How to Successfully Select a Translation Vendor: Best Practices and Common Pitfalls

Selecting the wrong translation vendor can cripple your new product launch or upgrade, waste your precious time, drive up your overall project costs and potentially result in significant lost revenue. What you don't know CAN hurt you!

The selection of the right language partner directly affects the success of your translation project. Whether your text is promotional or technical in nature and whether you need to have it translated into one language or many, find out how to select the right translation vendor to fit your company's specific needs. So that you can minimize the hassles and unexpected surprises that can occur over the course of a translation project -- big or small!

Learn how to avoid common pitfalls when selecting linguistic specialists and how to dig beneath the surface to find out who can really get the job done.

How to Successfully Select a Translation Vendor: Best Practices and Common Pitfalls was presented by Eve Lindemuth Bodeux, Founder of Bodeux International LLC. This audio conference aired on 2003-04-29 and is available at www.fxconferences.com

How to Evaluate Your RiskMAP

A key element of any Risk Minimization Action Plan (RiskMAP) is the description of ways in which the Sponsor will determine if the risk minimization efforts are working.

In this audio conference, Dr. Stemhagen discusses strategies and approaches for evaluating RiskMAPs, in conjunction with the types of risk minimization "tools" that can be implemented. She also describes the range of evaluation methods that can be used to evaluate risk management interventions, such as use of existing databases, market research data, and ad hoc data collection through registries and large simple studies. Dr. Stemhagen provides attendees with examples of metrics developed from ongoing programs, and outline strategies for selecting the most appropriate evaluation tools for the circumstances.

How to Evaluate Your RiskMAP was presented by Dr. Annette Stemhagen, VP Epidemiology & Risk Management, with United BioSource Corporation and aired on 2006-10-12. For more details or to purchase a download of this conference, please visit our site www.fxconferences.com

Biologic vs. Non-biologic: Current FDA Thinking on IVDs

In the United States, in vitro diagnostic products are classified and reviewed under two separate FDA Centers, depending on whether the product is intended to be used to diagnose a condition, predict if a particular treatment will be effective or monitor the effect of a treatment, or if it is intended to be used in the testing of transfusable blood or cellular products.

In this audio conference we highlight the differences in the two product review processes between the Centers and provide insight into their expectations regarding information required in submissions and following product approval. Recent Guidance Documents issued by FDA are discussed.

Biologic vs. Non-biologic: Current FDA Thinking on IVDs was presented by Ann Quinlan-Smith & Pamela J. Vaughan, President & Senior Principal Consultant, with Alquest, Inc. and aired on 2008-02-28. For more details about purchasing a download, please visit our site www.fxconferences.com

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have?

In our current business climate it seems like everyone is trying to do more with less, and that includes people at your workplace, too. So how can you maximize results when people are overwhelmed and stressed out? Through strategic talent development - and engaging people to further develop their skills and enhance their desirability to their employer. What if you don't have time to develop people? Is this time to strategically add people to your team? You bet.

Through GAP Analysis and Case Studies you will discover how to evaluate your current team, maximize their production, and produce better results. In this session, we will go step by step through a skills inventory and GAP Analysis to help you clarify your team member’s strengths and areas of development to meet or exceed your corporate objectives, and help you determine whether or not you need to hire to supplement team strengths.

Maximizing Results Through Your Workforce: Hire More People or Develop the People You Have? is being presented by Laura Raynak, Managing Director, with Raynak Executive Search and airs on Wednesday, January 21, 2009. For more details, please visit our site www.fxconferences.com

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs

Management of registries and other longitudinal studies creates unique challenges for sponsors, CROs, and other vendors. Programs of many years’ duration are faced with management and operational challenges. Management challenges include staff turnover at the sponsor as well as CROs and vendors. Proactive management of these staff changes that ensure successful ongoing team interactions is essential to program survival. Maintenance of project document history and documentation is another management challenge for long term programs. Ensuring that project decisions and documentation are well specified and accessible to all relevant stakeholders ensures common understanding and expectations across all stakeholder groups and assists project teams in addressing questions about decisions made by predecessor teams or team members.

Operational challenges for managing long term programs include changes in the marketplace and standards of care. Changes in these over time can significantly impact sponsor needs for data. Additionally data collection tools and strategies can also change significantly over time. Use of sequential adaptive methodology to anticipate potential changes at the program planning stage can facilitate changes as these are required over time.

Finally, challenges can be posed by turnover of site staff site, and long term involvement and enthusiasm of sites can be difficult to maintain. Strategies for successful engagement of sites for the study’s duration, and retraining of site staff over time require upfront planning and ongoing re-examination. Representatives from stakeholder groups including CROs, Other Vendors/Sponsors/Sites will discuss lessons learned from the management of long term programs including strategies that have contributed to successful management as well as pitfalls to avoid in managing future programs.

Managing Long-Term Registries: Strategies for Successful Management of Long-Term Clinical Programs is being presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and airs on Thursday, February 25, 2008. For more information or to register for the conference, please visit our site www.fxconferences.com

The Employee Free Choice Act: What it Means for Employers

If the Employee Free Choice Act passes, it may be the biggest shift in Federal Labor Law since the 1940s, and could severely affect your organization. Employers should understand and be prepared for the movement this Act will create toward a labor organization. This Act will amend the National Labor Relations Act and change the procedures in which employees choose to or not to join a union. Employers should be proactive in learning and creating a good offense to limit labor organizing.

Lisa Anne Friday, a leading expert in the Medical Human Resources field, will give a comprehensive overview of the act, and how it will impact the way you and your company do business. This presentation is set to arm you with a greater understanding of the Employee Free Choice Act and better understand the new climate your organization may be working under, should the Act pass in the first quarter of 2009.

The Employee Free Choice Act: What it Means for Employers is being presented by Lisa Anne Friday, Human Resource Division Director, with Community Health Systems and airs Wednesday, January 7th 2009. For more details or to register for this audio conference, please visit our site www.fxconferences.com

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)

December 31, 2009 is 385 days away. Why is this significant? European regulatory authorities are targeting January 1, 2010 for all national Competent Authorities(NCA) to accept eCTD-only submissions for marketing applications. In addition, for Sponsor organizations already filing eCTD submission in Europe, version 1.3 of the EU Module 1 specification for eCTD submissions is effective January 1, 2009. The EU Module 1 specification was revised in May 2008 to include section 1.10, Paediatric Information.

With the multiple filing procedures in Europe, the eCTD presents many interesting challenges. Which filing procedure is most appropriate? Should a Sponsor file individual submissions or combined submissions for the Reference Member State(RMS) and the Concerned Member States(CMS)? Which countries accept eCTD-only submissions, eCTD with a paper copy of one or more modules, or non-eCTD Submissions(NeeS)?

Now is the time for Sponsor organizations to recognize the true value of the eCTD for global regulatory submissions.

Electronic Submissions in Europe – eCTD and non-eCTD Submissions (NeeS)is being presented by Gina A. Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates and airs Tuesday, January 20th 2009. For more details or to register, please visit our site www.fxconferences.com

The New Rules for Continuing Medical Education

Both industry supporters (pharmaceutical, biotech and medical devices companies) and Continuing Medical Education providers have been affected by changes in the rules governing commercial support of CME programs. Industry support of CME has been scrutinized by Congress. The ACCME has issued new guidance, as well as a “Call for Comment,” on the issue of industry funding. The new PhRMA Code specifically addresses CME funding, as do certain state laws, most notably the new Massachusetts law governing relationships between industry and physicians.

Life sciences companies need to keep abreast of these changes to make sure their internal policies are consistent with the latest law and guidance. CME providers need to be current as well, both to maintain their accreditation status and to be sure they are able to remain competitive in the current environment. In this audio conference, we take a look at the new rules and what sponsors and providers need to do to comply.

The New Rules for Continuing Medical Education is being presented by Maria D. Buckley, with Nutter McClennen & Fish LLP and airs on Thursday, January 8, 2009. For more details or to register for this conference, please visit our site www.fxconferences.com

Risk Management Best Practices for Medical Devices

Managing risk has always been an integral part of medical device development, but is now becoming more integrated with quality management systems. Previous experience with “risk assessment” had been the application of risk analysis to determine specific risks associated with a device. This is no longer the case with a quality management system such as ISO 13485 and the recently updated ISO 14971 standard defining and clarifying the risk management process.

This presentation helps organizations to better understand how risk management can reach its full potential as a management tool. When there are complaints or adverse events for a product family, have these been addressed in the risk analysis? When does the risk management file get updated or reviewed? How does an organization go about creating a system to assure that risk management fulfills that role within the product life cycle? These questions will be answered as the speaker walks attendees through the process of implementing a risk management system within a medical device company.

Risk Management Best Practices for Medical Devices is being presented by Richard Vincins, Senior Consultant, with Emergo Group and airs on Thursday, January 22, 2009. For more details, or to register for this audio conference, please visit our site www.fxconferences.com

Effective Licensing in the Wake of MedImmune v. Genentech

The licensing of life science technologies, especially oncology-related technologies, is becoming an essential part of doing business. With MedImmune v. Genentech, the United States Supreme Court transformed the relationship between patent licensors and licensees. Historically, licensees were prevented from challenging patents on invalidity grounds. Now, a licensee may challenge a patent's validity while paying royalties to the licensor.

Although framed as a procedural question of standing to bring suit, the application of this Supreme Court case has the potential to shift the decision making of licensors and licensees and to significantly change the volume and cost of patent licensing activities. In this audio conference Dr. Samardija explores the Supreme Court decision and the various decisions that have followed, and provides attendees with 10 drafting tips to decrease the risks associated with a licensee challenging the validity of a patent.

Effective Licensing in the Wake of MedImmune v. Genentech is being presented by Michael R. Samardzija, PhD, with Bracewell & Giuliani and airs on Thursday, January 29, 2009. For more details, or to register for this conference please visit our web site at www.fxconferences.com

Global Patent Standards

Is your patent adequately protected in all of the markets where you do business? Are you sure about that?

In many industries, patent protection in both the United States and abroad is critical, but the requirements for each country are not necessarily the same. Thus, in developing a patent strategy, the different requirements of countries where protection is desired must be considered prior to filing.

In this audio conference, we review the various global patent standards in countries where patent protection is typically sought. Particular emphasis will be placed on written description requirements, obviousness and inventive step standards in the United States and in Europe.

Global Patent Standards is being presented by Christopher Rhodes, PhD, JD, Intellectual Property Attorney, with Lowrie Lando & Anastasi LLP and airs on Thursday, January 15, 2009. For more details or to register for this event, please visit our site www.fxconferences.com

Medical Device Research and Regulations in Israel

Israel represents the largest single medical device market in the Middle East, valued at roughly 885 million dollars and growing at an annual rate of almost 5%. There is an extensive medical network and high doctor-to-patient ratio, both reflected in a low infant mortality rate and high life expectancy. Distribution of medical conditions and trauma is comparable to the EU and USA.

Israeli schools provide medical professionals with Western-level training, and as a result the country operates on the frontier of medical technology development. With its experienced doctors and high-tech medical facilities, Israel offers medical device companies a regulated, accepting environment in which to conduct clinical studies of the highest quality. Study enrolment is high, as is data quality.

This audio conference provides attendees with information on the regulations governing Israeli clinical studies, and the requirements for placing your medical device on the market in Israel.

Medical Device Research and Regulations in Israel is being presented by Efraim Roe Kozorovitsky, Executive Director - Medical Devices, with Premier Research Group and airs on Thursday, February 5, 2008. For more details or to register for the audio conference, please visit our site www.fxconferences.com

Device Advertising and the First Amendment: Your Rights

Within recent years the effect of the First Amendment on FDA-controlled speech has drastically changed. Courts have stated standards for what FDA can do in controlling speech in advertisements. The difficult question is predicting the practical impact of these court decisions. FDA still has enormous authority to control speech and labeling. This presentation discusses the balance between FDA control of indications versus court restrictions on FDA control of speech.

Device Advertising and the First Amendment: Your Rights was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-08-23. This audio conference will be replayed on Wednesday, December 17, 2008 by popular demand. For more details or to register for this conference please visit our site www.fxconferences.com

Indications: The Next Battleground in FDA Advertising Enforcement

Recent Supreme Court decisions have provided new protection to commercial speech, challenging the manner in which FDA regulates industry. In response, FDA takes great care to not mention advertising and has shifted its enforcement focus to indications.

The Food, Drug, and Cosmetic Act (FDCA) does not give FDA broad control over advertising, yet it does give FDA explicit control over the approval/clearance process and the resulting indications. FDA is tightening up on statements in ads by closely interpreting indications. This makes it even more critical to plan and write accurate PMA and 510(k) scopes to prevent FDA enforcement.

This audio conference discusses the best way to work within the new reality of FDA advertising enforcement.

Indications: The Next Battleground in FDA Advertising Enforcement was presented by Robert J. Klepinski, of Fredrikson & Byron and aired 2007-01-18. For more details or to purchase a download of this event, please visit our site www.fxconferences.com

The Case for Value-Based Content Management

In these days of productivity gains and cost reduction at all costs, is what you are optimizing driving value to your customers? Are you maximizing ROI with your content and translation processes, but delivering content used most as doorstops and paperweights?

This presentation draws heavily upon the example of JD Edwards, a company that set the bar in how to efficiently single-source content, reuse it across multiple deliverables and outputs, and get it into target languages. JDE's optimized processes became the poster child for the localization industry and its single-source methodology became the model of best practices for content management thought leaders. Yet, in order to drive value to the customer and the bottom line, JDE had to shift from a cost-based optimization model to a value-based strategy.

Using this case study, we will trace the thought processes that led to the value-based breakthrough and then apply the system dynamic analysis to abstract the factors into a model that can be applied to other applications.

The Case for Value-Based Content Management was presented by Ben Martin, Partner, with Industrial Wisdom and aired on 2004-12-16. For more details or to purchase a download, please visit our site www.fxconferences.com

Risk Mitigation and Prevention in Real-Life Trials

Managing and preventing risk is an integral part of managing any clinical trial. This presentation showcases a series of real-life examples, and explore ways to leverage sophisticated tools and proactive approaches to managing project-related risk. Naturally, a flexible approach customized to each individual case is required, and this presentation shows how to go about it.

Acknowledging the need for continuous mitigation of project related risks, the speaker also explains and demonstrates methods for overcoming challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.

Risk Mitigation and Prevention in Real-Life Trials was presented by Jill Johnston, Senior Director, Project Management & Clinical Ops, with Covance and aired on 2007-04-05. For more details, or to purchase a recording, please visit our site www.fxconferences.com

Challenges Encountered & Lessons Learned in the New EU (IVD)

On May 1, 2004, the European Union expanded from 15 to 25 member states with the addition of Poland, Hungary, the Czech Republic, Slovenia, Slovakia, Malta, Cyprus, Estonia, Latvia and Lithuania. One year after these accession countries became full EU members, what has the experience been like for the IVD industry? What have been the toughest challenges to overcome? What has industry learned along the way?

This presentation examines those questions, as well as the current regulatory issues affecting IVD manufacturers in Europe.

Challenges Encountered & Lessons Learned in the New EU (IVD) was presented by Karen Howes, Director of Regulatory Affairs, with European Diagnostics Manufacturers Association and aired 2005-07-14. For more details or to purchase a download of this event, please visit our site www.fxconferences.com

State of Readiness? XML in the Life Sciences

The life sciences industry is being thrust into the world of XML. FDA's recently mandated Structured Product Labeling (SPL) initiative as well as private initiatives with Standard Response Letters, Clinical Data, and Product Information Management (PIM) for EMEA labeling have made it clear that the use of XML is on the upswing. But how do you benchmark your organization with your peers? What are the biggest problems in working with documentation?

ForeignExchange Translations, RWD Technologies, and Data Conversion Laboratory asked these questions to a broad cross-section of the life sciences industry through a comprehensive survey. In this presentation we unveil the results, looking at where the industry stands on XML initiatives, and where it needs to be. You learn how your peers are tackling the issues associated with SPL, Standard Response Letters, and Clinical Data Reports. You hear what they report as the biggest problems, and what they are doing to solve them.

State of Readiness? XML in the Life Sciences was presented by Don Bridges, Commercial Technical Documents Manager, of Data Conversion Laboratory (DCL) & Joe Jenkins, Life Sciences Market Director, of RWD Technologies and aired 2006-11-30. For more details or to purchase a download, please visit our site www.fxconferences.com

Navigating the European Human Tissue Maze

The European regulatory requirements over the past 10 years covering products using human tissue has been more than a little confused. Excluded from the Medical Device Directive, and not always appropriate to pharmaceutical rules, product manufacturers have had to deal with a raft of national regulations ranging from 'non-regulation' to 'medicines regulation'.

Although pan-European regulation has been mooted, the confusion is set to continue for at least two more years. In this audio conference, Phil Brown describes how this maze of regulation came about, as well as how the current European map offers opportunities for product introduction.

Navigating the European Human Tissue Maze was presented by Phil Brown, Sr. Consultant, with Quintiles Consulting on 2005-02-09. For more details on this conference, or to purchase a download, please visit our site www.fxconferences.com

Japan's Revised PAL: What Device Companies Need to Know

In 2002, the Japanese Ministry of Health, Labour and Welfare announced sweeping changes to its Pharmaceutical Affairs Law and the regulations governing the sale of medical devices in Japan. Japan represents a 10% share of the global medical device market, and it is vital that device manufacturers have a thorough understanding of the revised PAL if they wish to gain legal market entry.

This presentation gives an introductory overview of the structure of the Japanese regulations, and highlight the main requirements device companies must meet in exporting their products to Japan.

Japan's Revised PAL: What Device Companies Need to Know was presented by Steve McRoberts, Global Principal Engineer, Medical Regulatory Programs, of UL International (UK) Ltd. on 2006-01-11. For more details, or to purchase a download, please visit our site www.fxconferences.com

Global Unifying Trends in Device Regulation

Device manufacturers who want to reach world markets are faced with a plethora of regulatory schemes that appear to be disjointed and unconnected.

Although, at first glance, this may be true, there are some harmonizing influences afoot that wise manufacturers can take advantage of in marketing their products across the globe. The audio conference with explore these possibilities.

Global Unifying Trends in Device Regulation was presented by Harvey Rudolph, PhD, Global Program Manager, of Underwriters Laboratories on 2005-04-13. For more details on this audio conference, or to purchase a download, please visit our site www.fxconferences.com

How to Mark & Label Devices Under IEC60601-1 3rd Edition

Get up to speed on the latest requirements incorporated into the 3rd Edition of IEC 60601-1 and take the guesswork out of marking and labeling your medical devices.

Marking and labeling is just one area to tackle in the complicated development of medical devices, but it is a critical one to understand. How do you make sense of all those regulations? It’s challenging enough preparing and testing the device; then you have to worry about the user manuals, screen prompts and packaging too!

In this audio seminar, Leo Eisner guides you through each new, added or modified regulation incorporated into the most recent revision of IEC 60601-1. The third edition of this cornerstone standard for medical electrical devices sees major changes from version two you need to know for successful compliance. Ease your marking and labeling stress with detailed guidance from a leading expert.

How to Mark & Label Devices Under IEC60601-1 3rd Edition was presented by Leo Eisner, Product Safety & Regulatory Consultant, of Eisner Safety Consultants on 2007-10-23. By popular demand, we are re-broadcasting this audio conference on Tuesday, December 2nd, 2008. For more details or to register, please visit our site www.fxconferences.com

Improving Clinical Development with Six Sigma

The current industry model for drug development is premised on failure by the investigative sites, and most funds are spent finding and repairing mistakes. In comparison to most other industrial systems in the last 30 years, this reactive and repair-focused approach is an anachronism, which causes delays and cost overruns. In contrast, Six Sigma facilitates a systematic attack against site and project management performance variance by shifting the focus from error remediation to error prevention.

This presentation provides a high-level introduction to Six Sigma, practical examples of how has Six Sigma has been deployed, and its impact on drug development. The speaker explores how Six Sigma process improvements can be applied to clinical program execution and provide several real life examples. Other topics of discussion include hurdles to success, necessary organizational commitments to support transformative measures such as Six Sigma, and what types of results can be expected.

Six Sigma is NOT a quick fix for all development woes, and this presentation will provide examples not only of the good, but also the bad and the ugly, where Six Sigma projects were inappropriately selected or scoped, or not well operationalized.

Improving Clinical Development with Six Sigma was presented by Tim Strauss, Executive Director Business Process Improvement of Covance on 2007-07-12. This audio conference is available for download at www.fxconferences.com

New EU Rules for Tissue Engineered Products

After years of discussion, the Commission of the European Union finally published its proposed regulations for Tissue Engineered Products in November 2005. The decision has been taken to place such products under the Medicinal Regulation umbrella with other (already regulated) products such as Somatic Cell Therapy and Gene Therapy medicinal products, creating a new category, namely 'Advanced Therapies Medicinal Products'. In doing so however, the Commission acknowledged that Tissue Engineered Products require radical adaptations of the existing medicinal product regulation in order to succeed.

This presentation describes the scope and specificity of this new regulatory framework, and highlight areas where industry is likely to ask for adaptations. In addition, Dr. Chignon provides insight into where this new regulation fits within the existing framework of European Directives, so that the participants will better understand how they all work together. The presentation incorporates several product examples to help attendees better understand this new regulatory framework.

New EU Rules for Tissue Engineered Products was presented by Dr. Thierry Chignon, Principal Consultant & Director, of Quintiles Consulting Europe. This audio conference aired 2006-03-16 and is available for download at www.fxconferences.com

Biomarker Data Interpretation and Challenges of Biological Variation

With the emphasis on biomarkers to improve drug development the question arises as how to interpret the data.

The traditional clinical laboratory methodology for interpreting data involves the identification of the expected values (the normal range) and from this range defining the probably of disease or no disease (sensitivity and specificity). The challenge in drug development is in monitoring the patient over time while identifying if important changes have occurred in the biomarker values that indicate inappropriate toxicity or demonstrate appropriate efficacy.

The use of the reference interval as a means of identifying toxicity or efficacy will be challenged and an alternative approached based embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation is being presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, Covance Central Laboratory Services and airs Wednesday, January 28th 2009. For more details or to register for this audio conference, please visit our site www.fxconferences.com

e-Consent: An Idea Whose Time has Come

This presentation will discuss the key elements to consider in implementing e-informed consent. Based on currently implemented online trial consents, crucial steps in the implementation process will be described.

Drawing from current national and international trial experience with electronic multimedia informed consent and the research literature on multimedia consent, presenters will discuss key lessons learned concerning subject and trial characteristics that impact on implementation of electronic consent and its’ success in a clinical trial. The session will discuss a decision path for determining if e-consent can be effectively implemented for a trial.

e-Consent: An Idea Whose Time has Come is presented by Susan Brink, President & CEO, of ConsentSolutions, Inc. and Jovianna DiCarlo, President, of Accugenex Technologies, Inc. This audio conference airs on Wednesday, December 3rd 2008, for more details or to signup, please visit our site www.fxconferences.com

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting)

Inefficient medical device reporting presents a clear and present danger: It can damage your company’s reputation and even threaten your ability to operate. After sending some mixed signals in the second half of 2007, FDA eMDR experts have said they’ll mandate eMDR within two years. The only debate now is how quickly it will happen, and what kind of timeline mandate will be imposed.

It’s therefore not surprising to learn the agency is pushing harder for eMDR (electronic medical device reporting) than anyone else. By attending this audio conference, you'll learn more about the future of eMDR, the options available to you now, and why it makes good business sense to implement an electronic medical device reporting system today.

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting) is presented by Tamar June, Vice President of Strategic Marketing, of AssurX. This audio conference airs on Wednesday, December 10th, 2008, for more details or to register, please visit our site www.fxconferences.com

International Sponsor-CRO Relationships: A Legal View

An ever-present issue for sponsor companies is whether to partner with a Clinical Research Organization. From that follows questions and strategies on how to best select a CRO and manage the relationship. The process takes on added dimension when conducting research internationally.

In this presentation, the speaker highlights key contract and relationship issues and the recurrent problems that arise within these relationships, and also offer practical, experience-based tips for maximizing the relationship's value and efficiencies. We discuss the difference between partner and vendor, and contract versus relationship. The presentation also examines local vs. U.S.-based CROs, and how to assess a CRO's experience and ability to comply with local rules and regulations and FDA requirements, as well as cooperating with the sponsor and other participating CROs.

International Sponsor-CRO Relationships: A Legal View was presented by Maria D. Buckley, of Nutter, McLennen & Fish, LLP. This audio conference is available for download at www.fxconferences.com

Recruiting Research Participants Using Web-Based Software

Could the Internet be the key to driving participation in your clinical research? More and more institutions and organizations are successfully using web-based software to recruit larger numbers of research participants for clinical trials and studies. Internet technology can increase recruitment numbers and enrollment, and increase the revenue to the institution when studies are filling with subjects. Anyone with Internet access can get the information they need, register, provide consent, answer a series of questions, and join a pool of potential research participants online.

In this audio conference, our speakers examine how web-based software can make patient recruitment faster and more efficient, and provide real-life examples of the positive results achieved at two leading health care institutions.

Recruiting Research Participants Using Web-Based Software is presented by Marjorie Tharp, mdlogix and Charles Rathmann, Washington University. This audio conference airs on Thursday, Dec. 11, 2008, for more details, please visit our site www.fxconferences.com

Pharma 2010: The Threshold of Innovation

While some analysts predict the pharmaceutical industry will grow by 9% by the year 2010, IBM Business Consulting Services is anticipating a much lower rate of 5.3%. However, in Pharma 2010: The Threshold of Innovation, IBM predicts that a new business model based on Targeted Treatment Solutions has the potential to achieve breakthrough growth. The authors propose that this new business model is needed to meet the challenge of governments and insurers who are no longer willing or able to pay high prices for "me too" medicines.

This presentation provides an in-depth overview of the "Pharma 2010" strategies that will lead to a more adaptive and flexible way of conducting business and treating patients.

Pharma 2010: The Threshold of Innovation was presented by Sam Barnett, Lead Partner, Life Sciences & Pharma of IBM Business Consulting Services and aired on 2004-06-29 and is available for download at www.fxconferences.com

Moving Target: Animal Tissue Regulations Update

Animal tissues have been utilized in medical devices and pharmaceuticals for many years, but the change in the 'state of the art' has meant an understandable and justifiable increase in the awareness of safety issues.

Directives such as 2003/32/EC and Regulation 1774/2002 have steadily increased the burden on the manufacturer to demonstrate safety. Moreover, additional guidelines from the CVMP/CPMP, monographs from the EDQM, and standards covering viral contamination potentially add to the confusion. Was your medical device product in compliance before the October 2004 deadline? Is the EDQM procedure too much of a challenge?

In this audio conference, Phil Brown looks at the development of -- and explains the differences between -- the Directive, the Regulation and all the other documents, with the aim of providing some clarity.

Moving Target: Animal Tissue Regulations Update was presented on 2005-03-09 and is available for download, for more details please visit our site www.fxconferences.com

Optimizing RFPs: Simple Steps to Better Responses

Is your organization in the process of putting together an RFP? Have the responses to your past RFPs fallen short of expectations? CRO teams respond to hundreds of RFPs each year. It is clear which sponsors have invested time to build internal consensus and to develop a document that clearly articulates their needs and project goals. The result is a guide that assists the CRO in assembling a higher quality response that directly addresses the needs of the sponsor.

This audio conference is the first in a three-part series designed to share best practices for optimal outsourcing.

Optimizing RFPs: Simple Steps to Better Responses was presented by Beth Mandel, Director of Strategic Solutions, with Covance. It aired on 2006-12-06 and is available to download at our site www.fxconferences.com

Optimizing Site Performance: Risk Planning vs. Remediation

What causes the widespread variance in site performance in clinical trials, declining data quality and missed timelines? What can drug development service providers and sponsors proactively do to optimize site performance?

A large percentage of clinical trial budgets is allocated to fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors. This audio conference discusses protocol violations as a consequence of stressed environmental conditions at investigative sites. The presentation looks at why these violations are so pervasive, and the inability of conventional measures to adequately detect and address them. The speaker then discusses how protocol violations are preventable within a risk management paradigm, and outlines a process for addressing them using Failure Mode and Effect Analysis (FMEA).

Optimizing Site Performance: Risk Planning vs. Remediation is being presented by Pam Atwell, Director, Operational Strategies and Planning, of Covance Clinical Development Services and airs Thursday, Dec. 4, 2008. For more details or to register, please visit our site www.fxconferences.com

Real-Time Adverse Event Analysis Using IVR

This audio conference provides an overview of practical considerations regarding the challenges of obtaining adverse event (AE) data, particularly in real-time. A fundamental challenge in the adverse event reporting arena is a lack of, or incorrect, information on patient exposure data and AE incident reporting.

This presentation suggests a strategy for utilizing your IVRS data stream to enhance understanding of patient exposure and enable real-time, proactive decision-making on the progress of the clinical trial. Data already captured in your IVR can provide significant insight into clinical trial performance and improve your understanding of adverse events in your trial. The strategy presented in this audio conference enables you to immediately improve your understanding of AEs without any additional capital expenditure.

Real-Time Adverse Event Analysis Using IVR was presented by Hal Ward, Executive Director Global Head of Drug Safety of Covance on 2007-08-15 and is available for download at www.fxconferences.com

Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams

Today, whether the task is to develop a new drug, launch a product or work on a strategic project, much of our work is done through global teams. These teams are usually cross-functional, cross-geographic, cross-cultural and span multiple time zones. They may also cross company lines through strategic alliances. They face the challenges of having to work "virtually", with a balance of high tech and high touch.

Based on Lynda's experience working with over 1,000 global teams in over 25 countries, She will provide the participants with "best practice" learnings and tools relevant to developing and leading world class global teams.

Building Bridges: A Practical Guide to Leading Global Pharma and Biotech Teams is presented by Lynda McDermott, President, of EquiPro International and airs Wednesday, November 19, 2008. For more details or to register please visit our site www.fxconferences.com

Marketing Your Medical Device in Canada

Despite the downturn in the global economy, Canada remains an important and growing market for medical device manufacturers. However, differences between Health Canada and FDA regulations and device classifications have resulted in some confusion over the best approach to take when entering the Canadian marketplace.

This presentation covers the basic steps you will need to take to obtain the appropriate licences for your company and/or medical device (e.g. Medical Device Licence or Medical Device Establishment Licence). The presentation will include a discussion about the Canadian Medical Device Regulations, the role of ISO 13485:2003 CMDCAS, and issues related to language translation.

Marketing Your Medical Device in Canada is presented by Daryl Wisdahl, Director, of Wisdahl Consulting Group and airs on Thursday, Nov. 20, 2008. For more details or to register for this conference, please visit our site www.fxconferences.com

Managing Global Market Research for Consistency and Insight

Medical companies are increasingly sponsoring global research projects – but is this research effective? How can cultural and linguistic differences be managed to ensure the integrity of the result? Are differences between cultures just skin deep or do they extend to personality? How can we create research metrics that will have consistent meaning around the world? In this Webinar we will provide understanding of these issues and tools for managing global research projects.

Managing Global Market Research for Consistency and Insight is presented by Peter Simpson, President, of Segmedica and airs Wednesday, November 12, 2008. For more details or to register, please visit our site www.fxconferences.com

Brand Development and Enforcement Strategies

In uncertain economic times, it is especially important that companies develop strong, identifiable, unique and protectable trademarks and brands, and enforce against encroachment. In this presentation the speaker covers the entire range of brand development, from brand selection to trademark searching and counseling, international brand registration and brand expansion.

The presentation also covers enforcement strategies for brand owners, with discussion on improper importation of counterfeit or infringing merchandise and the steps that can be taken at the border to prevent it. Other enforcement targets to be discussed include: counterfeiters operating at the local level; distributors, exporters and manufacturers operating up the commercial line; and infringers who do not directly copy a brand, but use marks likely to cause confusion. The presentation also covers brand development and enforcement over the Internet.

Brand Development and Enforcement Strategies is presented by Anthony F. Lo Cicero, Intellectual Property Attorney of Amster Rothstein & Ebenstein LLP and airs Tuesday, Nov. 25, 2008. For more details or to register, please visit our site www.fxconferences.com

The New Europe: Overview for Device Manufacturers

The new 25-member European Union has its roots in World War II and the Cold War. It is a collection of 25 very different markets in terms of size and development.

Although European law and policy attempts to create a huge single market of more than 450 million people, in reality much of that market is still highly segmented. The legacy of Communism still weighs heavy in most of the new members that joined in 2004, affecting the ability of Western medical device manufacturers to do business and deal with regulatory issues in these countries.

The New Europe: Overview for Device Manufacturers was presented by Mika Reinikainen, VP, of Quintiles Consulting on 2004-09-16. For more information, or to download this product, please visit our site www.fxconferences.com

The Revised MDD: Practical Implications for Devices

The Medical Devices Directive (MDD), which sets down the rules and regulations for marketing medical devices in the EU, is in the final stages of a lengthy revision process. The general consensus is that the directive has been working well to date, but that certain aspects need to be tightened up. To this end, there are no radically new requirements, but there will be an increased demand for clinical data and post-market surveillance. What will this mean for medical device manufacturers?

In this audio conference, Dr. Helen Colquhoun summarizes the revisions and describe in detail those with the greatest potential impact. She discusses the implications of these revisions for medical device manufacturers, illustrating points with practical examples and using different scenarios to explain how best to approach the issues raised.

The Revised MDD: Practical Implications for Devices was recorded on 2006-02-23 and is available for download at www.fxconferences.com

Writing & Designing for an International Audience

Are you responsible for generating content for global markets? Are you worried that the meaning in your message might be lost or altered because of cultural differences? Culture, translation, writing, and design interweave in curious ways when preparing content for an international audience. These elements require important skills for creating global content, especially given the increasing pressure to standardize and comply with various international and internal standards.

This presentation highlights some key contradictions inherent in writing and designing for a multicultural and multilingual audience and discuss proven strategies for their resolution.

Writing & Designing for an International Audience was recorded on 2007-12-11 and it running again Oct 29th, 2008 by popular demand. For more details or to register, please visit our site www.fxconferences.com

What You Need to Know to Get Started in XML

So you've heard about XML, and now you are trying to decide whether or not to start using it at your company. Or, perhaps you are just curious about what XML is and whether it lives up to the hype. Maybe your boss has made noises about converting to XML, and you need a crash course on the subject.

This presentation is aimed at giving those with little or no knowledge of XML an overview of what exactly XML is, and what it is -- and is not -- good for.

What You Need to Know to Get Started in XML was presented by Kit Brown, Principal, of Comgenesis LLC, and is now available for download. For more details or to download this audio conference, please visit our site www.fxconferences.com

Workflow & Version Control: Taming the Documentation Tiger

Take a look at your email inbox. Chances are someone has sent you a working document as an attachment because they are finished with it and now it's your turn. It's also a good bet bet that the folder containing your current project has file names like Operation-v1.doc and Operation-v2.doc. Every document goes through some kind of workflow and version control. Many companies do this using email attachments and file naming conventions. A true document management environment will include workflow and version control, but these systems are usually too costly for the small documentation shop.

In this audio conference, Brian Travis discusses the shortcomings of current document management practices, and ways to streamline and improve the process.

Workflow & Version Control: Taming the Documentation Tiger was presented on 2007-05-10 and is available for download. For more details or to download this conference, please visit our site www.fxconferences.com

Writing for Translation: The 1% Solution

Why should you learn how to use Controlled English? Increasingly, documentation must be designed for two distinct but related types of audiences—-those reading the text in translation, and those for whom English is a second language.

While many businesses still have their documentation translated, English is quickly becoming the standard of our global village. But English is a complex language to read, write, and understand. Using Controlled English makes documents easier for non-native English speakers to understand, and the more consistent, less ambiguous language also makes for less expensive translations. It is critical that technical documentation and training manuals clearly convey meaning in fields with complex products and liability issues.

This audio conference explains how 1% of the English language is sufficient to communicate with customers in 181 countries. It will also cover the steps to implement Controlled English and its pitfalls and benefits for the translation of technical documentation.

Writing for Translation: The 1% Solution was presented by John Smart, SMART Communications, on 2005-06-21 and is now available for download. For more details or to purchase a recording, please visit our site www.fxconferences.com

An Introduction to Regulatory Writing: Creating an Effective Message

Did you ever wonder what reviewers look for in your regulatory submissions? This audio conference combines the results of two in-depth interviews regarding effective writing in regulatory submissions and with known effective writing techniques and practices. The interviews were with a previous FDA reviewer and a current reviewer for a large Notified Body. Both interviewees shared their reactions to the quality and effectiveness of the writing in the hundreds of submissions they have each reviewed.

Topics include: analyzing the audience, identifying topics, organizing the topics in a logical way, applying document design principles, establishing document management conventions, writing, and assessing the effectiveness of your writing.

An Introduction to Regulatory Writing: Creating an Effective Message is being re-broadcast on Tuesday, October 21st, and is presented by Nancy Hoft, of Nancy Hoft Consulting. For more details or to register, please visit our site at www.fxconferences.com

Registering Device Trials on ClinicalTrials.gov

It has been a full year since Title VIII of the Food and Drug Administration Amendments Act of 2007 expanded the scope of information that must be registered in ClinicalTrials.gov and mandated the inclusion of medical device trials. Additional new requirements also included increasing the amount of trial information, requiring results, and setting penalties for noncompliance.

One year later, the medical device community still has a lot of questions about its requirements and responsibilities for compliance with Title VIII, and the FDA is still working on providing the answers and guidance. This audio conference looks at the latest information surrounding registration of medical device trials and what you need to do to be in compliance.

Registering Device Trials on ClinicalTrials.gov is presented by Amy Wise, Manager of Clinical Research, of PharmaNet and airs Thursday, Nov. 13, 2008. For more details or to register, please visit our site www.fxconferences.com

Search Marketing: What Healthcare Marketers Need to Know

With over 80% of consumers and business people starting their quests for information on the Web via the major search engines, search marketing has become a critical component of a successful marketing strategy. While an expertly executed search marketing campaign is a cost-effective and easily measured investment, there are many misconceptions about what search marketing is, how it works, and which practices (known as “black hat”) can cause your brand irreparable harm

Veronica “Niki” Fielding of Digital Brand Expressions will cover the basics of search marketing and what it means for the life sciences industry. Attendees will get an executive review of the four key components used to generate visibility on Google and the other major search engines. These are: - Search engine optimization - Search engine advertising - Search engine reputation management - Social media management.

Search Marketing: What Healthcare and Pharma Marketers Need to Know is presented by Niki Fielding, President, of Digital Brand Expressions and airs Wednesday, October 29th, 2008. For more details or to register, please visit our site www.fxconferences.com

20 Tips for Better Telephone Presentations

We live in an age when even the smallest of companies routinely operate on a global scale. Meanwhile, the cost of travel continues to spiral ever higher. As a result, many businesses are cutting back on face-to-face meetings, relying instead on teleconferences, webinars and other communications vehicles to make the connection with clients and prospects. However, while it is comparatively cheap and convenient to give presentations and conduct meetings using the telephone or web-based technology, it is not without its drawbacks. This presentation discusses the most common pitfalls, and provides actionable tips for more professional and effective long-distance business relations.

20 Tips for Better Telephone Presentations is presented by Rob Wagner, Executive Producer, of FXConferences.com and airs Wednesday, October 15th. For more details or to register please visit our site www.fxconferences.com

Integrating Data Streams for More Efficient Trials

Are you interested in faster clinical trials and improved data quality? For most sponsors and CROs, the answer would be an emphatic "Yes!". Managing a clinical trial effectively requires collaboration across multiple trial requirements. This presentation illustrates how IVR/IWR and lab data can be integrated and reconciled in real-time, improving the speed and overall quality of trial results. The presentation uses real-life case studies to demonstrate the trial efficiencies and benefits gained when combining labs and IVR/IWR data in real-time. The speaker also discusses technical considerations to enable an integrated data stream.

Integrating Data Streams for More Efficient Trials is presented by Vicky Czarnik, Senior Technical Strategy Manager, of Covance IVRS and airs Thursday, Nov. 6, 2008. For more details or to register, please visit our site www.fxconferences.com

Conducting Exploratory Trials in Scandinavia

Debating where to take your trial? While emergent research settings like India and Asia have captured much of the media spotlight in recent years, there are few places in the world better-suited for phase 1 and phase 2 clinical trials than Scandinavia. Populations in the Nordic region are ethnically homogeneous with a majority of caucasians. Both governments and populations generally display a positive attitude toward clinical research, and trial participants have high compliance rates. All citizens have free and equal access to healthcare, preventing sampling bias due to differences in social status. Health care facilities in the region all have access to state-of-the-art medical equipment, and the infrastructure is of the highest standards. In this audio conference, the speaker discusses these and other factors that make the Scandinavian countries a leading choice for exploratory trials.

Conducting Exploratory Trials in Scandinavia is presented by Dr. Claes Strom, Partner and COO, of aCROnordic and airs Thursday, Oct. 30, 2008. For more details please visit our site www.fxconferences.com

How to Write for a Global Audience

In today's world, technical documentation must be designed for multiple audiences - both the users who read the text in translation, and those for whom English is a second language. By using Controlled English and authoring with an eye to translation, companies can make the entire process of product globalization faster, cheaper and less prone to errors.

This audio conference provides some basic guidelines on how to write for a global audience, enabling attendees to reduce the cost and improve the quality of translations, improve training and customer support, and protect their companies from litigation under the "failure to warn" principle.

How to Write for a Global Audience was presented by John Smart, President, SMART Communications on 2006-05-18 and is now available for download at www.fxconferences.com

Best Practices for Medical Device Design

Medical device design should not be the result of happenstance. Device development by happenstance might or might not be successful. However, there do exist within the process opportunities for improvement.

This presentation highlights brief case studies concerning the development of several novel medical devices. It will also examine the practical realities faced by the developers, and discuss their respective approaches. The presentation also looks at key factors leading to failures and successes of device design.

Best Practices for Medical Device Design was presented and recorded on 2005-03-16 and is now available for download at www.fxconferences.com

Changing Your Approach for Success in Post-Market Research

There is a growing industry awareness of post-marketing research, thanks to the many pressures surrounding this phase of drug development. The demands of new regulatory guidelines, decreased pipelines, challenges to extend life cycle management, and increases in drug and healthcare costs, have propelled pharmaceutical and biotech personnel into the world of post-marketing research. These changes have, in turn, made it necessary to understand the differences between pre-marketing and post-marketing environments.

In this audio conference, the speaker provides a fresh perspective and useful tools to help attendees strategically plan and execute post-marketing research.

Changing Your Approach for Success in Post-Market Research is presented by Maria Harrison, Vice President, Late Phase Development, of PRA International and airs Thursday, Oct. 16, 2008. For more information or to registration, please visit our site www.fxconferences.com

Partnering with the New e-Patient for Recruitment Success

The Internet has changed the way people approach their own health care, creating a new breed of engaged, empowered consumer known as the ‘e-patient’. They are taking charge of finding information about their diagnoses and treatment options, and they aren’t shy about interacting online with other patients to exchange experiences and learn more. The most active searchers, according to a groundbreaking white paper by Dr. Tom Ferguson and the e-Patients Scholars Working Group, are acute (newly diagnosed) and chronic patients – arguably, the optimal candidates for clinical trial participation.

This conference profiles the new e-patient, offers strategies for getting his/her attention, and assesses the benefits and challenges of partnering with this population to optimize clinical trial participation.

Partnering with the New e-Patient for Recruitment Success is presented by Linda Wolf & Yuriy Zhuk, of BBK Healthcare, and airs December 16th, 2008. For more details or to register, please visit our site www.fxconferences.com

Global Clinical Studies: Logistical Challenges from Supply to Assay

As the nature of clinical trials becomes more complex, the focus and expertise of personnel involved has become more specialized. To manage a successful study, awareness of all aspects in this process is critical.

In this audio conference, Ms. Oliver reveals all of the logistical challenges involved in clinical studies and effectively illustrates them through two scenarios: 1) drug distribution through delivery and 2) specimen transport from patient to assay.

Takeaways include Tips for successful logistics planning in global clinical studies, Strategies for effective clinical supply shipping, and many more. Global Clinical Studies: Logistical Challenges from Supply to Assay is presented by Karen Oliver, Director Global Accounts, of World Courier, and runs Wednesday, October 8th, 2008. For more details or to register please visit our site www.fxconferences.com

Ensuring GCP-Compliant Trials with Clinical Quality Audits

In the race to start and complete clinical trials, securing investigator, CRO, and sponsor GCP compliance can be an overwhelming task. Clinical quality audits are an essential tool in ensuring that clinical research is conducted in accordance with GCP requirements. Given the pressures of executing efficient and expedited research, including audits in your overall clinical investigative plan increases the quality of research data and protects sponsor investment. Addressing compliance issues early and consistently, through corrective and preventative action, enhances data integrity and the quality of the overall clinical trial.

This audio conference provides attendees with tips for an efficient and effective clinical audit strategy, along with tools to assist in conducting GCP audits of clinical investigators, clinical research organizations and sponsors.

Ensuring GCP-Compliant Trials with Clinical Quality Audits is presented by Carol Houts, Director of Regulatory, Quality and Safety, with Pleiad on Thursday, Oct. 9, 2008. For more details or to register. please visit our site www.fxconferences.com

Setting Up and Managing a European Distribution Network

Lining up European distribution can be a daunting challenge. The European market is the largest consumer and industrial market in the world. The European Union (EU) has added 12 countries since May 2004, bringing the total population of the 27 EU countries to almost 500 million. The European medical technology market has 30% of the world market. With an aging population, this market has huge growth potential and is the recipient of almost half of all US medical technology exports.

To be successful in Europe, you need to set up distributors in each local market. After you determine which countries have the highest market potential, it is vital to conduct a thorough screening & selection process to find the best possible distribution partners in those countries. In addition to setting up distributors, you may also need to consider a European support structure to accommodate long term growth, including European warehousing, reverse logistics, and potentially European product support.

This presentation focuses on the challenges of doing business in Europe, with practical advice for handling key distribution and product support issues.

Setting Up and Managing a European Distribution Network runs Tuesday, Oct. 21, 2008 and is presented by Michael van der Woude, Partner, of EDM Services. For more information or to register, please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker discusses the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation also examines the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented Thursday, Sept. 18, 2008 by Linda Alexander, CEO & Founder, of Alquest. For more information, please visit our site www.fxconferences.com

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations

Is your company preparing to market a new pharmaceutical product in Europe? Pharma companies intending to bring new products to market in the EU must follow one of three distinct processes – Centralized Procedure, Decentralized Procedure or Mutual Recognition. Previous presentations by Dr. Granzer have dealt with Centralized Procedure. This presentation focuses on the other two methods, Decentralized Procedure and Mutual Recogniton.

These procedures can be used for certain new drugs, generics and herbal medicinal products. In the case of the MRP there must be a national marketing authorization in place, whereas DCP can be used to seek approvals where none currently exist. This presentation provides an overview of DCP and MRP, including which procedure is appropriate for which products, the expected timeframe for each, and the kinds of submissions expected.

Using Mutual Recognition and Decentralized Procedure for EU Drug Registrations is presented by Dr. Ulrich Granzer, of Granzer Regulatory Consulting on 2008-10-02. You can register at our site www.fxconferences.com

21 Steps to Easier Globalization through Better Writing

Going global? Many of the problems encountered during the globalization process can be traced back to the earliest stages of developing product documentation. The good news is most of these problems can be avoided by following a few basic rules.

John Smart has spent over two decades helping companies market to 218 countries. In this presentation, he will describe the 21 most common problems encountered in writing for a global audience, identifying each type of error, describing the problem and showing how to make corrections. The presentation uses real-life examples to highlight potential cultural problems, including inappropriate number and color references, and the confusing use of dates and numbers. Listeners will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing was recorded on 2005-09-27 and is now available for download at www.fxconferences.com

Introduction to ISO 13485:2003 and ISO 14969

ISO 13485:2003 has hit the street several years ago. Understanding the impact that these standards have on devices and diagnostics will help you to develop a forward-looking ISO strategy.

Drawing on her work with industry-leading device and diagnostic companies on ISO standards, Sue Spencer discusses the technical and strategic challenges being faced by those charged with maintain ISO. This audio conference walks you through the maze of updates to ISO 13485:2003 and provides insight to supporting guidance document ISO 14969.

Introduction to ISO 13485:2003 and ISO 14969 was recorded on 2003-07-16 and is now available for download at www.fxconferences.com

Industry Update: Revisions to the Medical Devices Directive

Due to the widely held view that certain aspects needed to be clarified, the EU Medical Devices Directive (MDD) is being revised. A number of proposed revisions have been under consideration for over a year now. Among the likely changes, there will be an increased demand for clinical data and post-market surveillance.

In this audio conference, Dr. Helen Colquhoun provides an update on the review progress, and describe the revisions, giving detail on those of greatest importance to device companies.

Industry Update: Revisions to the Medical Devices Directive was recorded on 2007-02-22 and is now available for download at www.fxconferences.com

CE Marking: 7 Steps to Getting Started in Europe

With a population approaching a half-billion people, the EU represents arguably the most lucrative market today. However, before any medical device company can sell in Europe, it must first obtain the CE Mark. The process of obtaining approval to affix the CE Mark to your product differs significantly from the US FDA system.

This presentation covers the basic steps companies need to follow in obtaining the CE Mark, including a discussion about ISO 13485:2003 and how it differs from FDA Good Manufacturing Practices (GMP), issues related to language translation and labeling, creation of a Technical File and how this differs from the FDA 510(k) application, dealing with Notified Bodies, selecting an Authorized Representative and an overview of the costs and timelines involved in achieving certification.

CE Marking: 7 Steps to Getting Started in Europe was recorded on 2007-04-03 and is now available for download at www.fxconferences.com

The EU Perspective on Risk Management

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commercialization.

In this audio conference Dr. Blesse will provide a detailed overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use and its legislative background. He will also provide examples of why this new regulation should not be perceived as another threat to industry, and how it offers strategic options.

The EU Perspective on Risk Management was recorded on 2007-07-19 and will replay on September 16th, 2008 at 11:30 Eastern time. For more information on this audio conference, please visit our site www.fxconferences.com

Adaptive Trial Design: Streamlining the Clinical Supply Process

Adaptive trial design has generated intense press coverage and industry excitement as it represents a significant change from traditional study design. This type of trial uses real-time patient information to make critical trial decisions as the study is ongoing. While this design offers the pharmaceutical industry the opportunity to speed up the drug approval process, mid-trial changes to treatment arms and patient populations has a significant impact on drug supply management.

From a clinical supply perspective, the inventory implications of an adaptive trial design must be carefully analyzed. Cost vs. benefit analysis is paramount as well as identifying inventory strategies for all possible scenarios well before first patient in (FPI).

Adaptive Trial Design: Streamlining the Clinical Supply Process is presented by Geert Langendries, Covance IVRS Project Management Group. This audio conference was recorded on 2007-12-05 and is now available for download at www.fxconferences.com

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees

Even when employee benefits material is well translated and presented in Spanish, many companies find that Spanish speakers are still reluctant to participate and instead opt out of very valuable opportunities for health coverage, retirement plans, etc. This tendency is frustrating to HR professionals, brokers and benefits providers who have invested putting together a Spanish presentation.

This discussion addresses misconceptions Spanish speakers commonly hold about insurance and finance in this country and present practical and cost-effective strategies for conducting effective enrollment meetings and maximizing participation among Spanish speakers in benefit plans.

Achieving Benefits Plan Buy-In from Spanish-Speaking Employees is presented by Melissa Burkhardt, President, of Futuro Sólido. This audio conference was recorded on 2008-05-28 and is now available for download at www.fxconferences.com

A Guide to Efficient Translation Management

Managing translation projects efficiently is all about choosing the right tool for the job. Translators use translation memory tools. Localizers use localization tools. What specialized tools exist for managing translation projects? When is automation and workflow management the answer?

This presentation, Angelika Zerfass provides an overview of the latest tools and technology available to the translation project manager, from small helpers to full-fledged workflow management tools. Learn how and when these tools can help them work faster and more efficiently, cutting costs and improving translation quality.

A Guide to Efficient Translation Management was previously recorded on 2005-12-15 and is now available for download at www.fxconferences.com

3 Steps to Successful Translation Management

Translators have been around since the time of the Babylonians, yet the US translation industry is still relatively new. Yellow Pages translation bureaus are a dime a dozen, but pharmaceutical, device and diagnostics companies need a true partner that can help them effectively manage the translation process.

This audio conference will give you the skills to evaluate different vendors, service delivery methods and quality. It will also enable you to put in place a process to document, measure, audit and improve your overall translation activities.

3 Steps to Successful Translation Management is presented by Andres Heuberger, President, ForeignExchange Translations, Inc. This audio conference was previously recorded on 2008-01-30 and is now available for download at www.fxconferences.com

Adapting Patient Recruitment to Global Cultures

Patient recruitment is often mistakenly equated with advertising, when in actuality it is a considered collection of practices in response to a problem or a set of risks. The discipline is still new to many world regions outside of North America, presenting challenges both in acceptance and in practice among study professionals globally.

This audio conference will focus on overcoming those challenges in order to successfully conduct patient recruitment globally using the most appropriate, effective, and ethically acceptable tactics. In addition, it will also illustrate methods for culturally adapting patient recruitment practices - particularly creating patient communications (including advertising) - to resonate with target populations in each country.

Adapting Patient Recruitment to Global Cultures is presented by Rob Laurens, Leader, Creative Services & Matt Stumm, Senior Art Director, of BBK Healthcare. This audio conference was previously recorded on 2008-01-23 and is now available for download at www.fxconferences.com.

Protecting Data Under Current EU Pharma Legslation

European pharma legislation has seen several major changes come into effect over the past several years. Amongst others, the data protection rules have changed substantially. The data protection period for new approvals is now 8+2+1 years. The orphan protection, a full market exclusivity period, is 10+2 years. And the very recently introduced legislation on paediatric drugs (PUMA and PIP) plays an important role as well. The concept of the "Global Marketing Authorisation" needs consideration for the planning of the effective data protection period.

This presentation helps attendees understand current EU data protection rules and how best to operate within the regulatory framework.

This event is presented by Ulrich Granzer, owner of Granzer Regulatory Consulting & Services. To learn more, please visit www.fxconferences.com.

Medical Device Clinical Evaluations: EU vs. US

In this presentation, Dr. Colquhoun explains the circumstances in which medical device manufacturers need to generate de novo clinical data. The audio conference also looks at the different types of clinical evaluations and the importance of conducting them in the EU (and USA).

The speaker presents an overview of the regulatory and quality controls of evaluations being conducted in the EU, and then highlights specific requirements in the four most popular European countries for medical device evaluations. These requirements are then compared and contrasted to those of the USA. Finally, the presentation addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.

This event is presented by Dr. Helen Colquohoun of Pleiad Devices. To learn more, please visit www.fxconferences.com.

The FDA & Risk Management for Biopharm Sponsors

What is required of biopharmaceutical sponsors by the FDA when it comes to managing risk? What are the best strategies for implementation?

The first part of this presentation focuses on the status of the FDA Guidance Documents on Risk Management back in 2005, including a description of what the FDA has termed the "toolbox" for Risk Minimization Action Plans (RiskMAP). The second part discusses the conduct of these unique programs through large simple trials, registries, and other approaches.

This event is presented by Annette Stemhagen of Covance. To learn more, please visit www.fxconferences.com.

Pitfalls and Best Practices for IVD Directive Language Requirements

Back in 2002, the $9 billion U.S. in vitro diagnostics (IVD) industry was ill prepared to meet the strict new regulations contained in the European Union's new IVD Directive. With only four business quarters left before the December 2003 deadline, IVD companies were realizing that translation is critical to earning the CE mark.

Manufacturers without effective plans for complying with the language requirements of the directive risked losing revenue and market share. Translation quality control, global labeling strategies and in-country reviews presented new challenges for the majority of diagnostics manufacturers who were dealing with non-English texts for the first time.

This event is presented by Andres Heuberger of ForeignExchange Translations. To learn more, please visit www.fxconferences.com.

The Foreign Corrupt Practices Act: Compliance Strategies

The Foreign Corrupt Practices Act (FCPA) is a U.S. anti-corruption law jointly enforced by the Department of Justice and the Securities and Exchange Commission. Its main provisions deal with improper payments to foreign offficials and questionable accounting practices to cover up these sorts of transactions. Violating FCPA requirements can result in criminal and civil penalties, and the law has had a major impact on the way companies conduct business abroad. The requirements of the FCPA are complex and apply to both companies in the U.S. and foreign-based companies subject to U.S. securities laws. Past enforcement actions have crossed industry boundaries and included the oil industry, telecommunications and pharmaceuticals. Recently, an increase in FCPA enforcement activity in the medical device industry has caught the attention of CEOs, CFOs, and Marketing and Sales executives.

In this audio conference, our speakers will combine their experience with real-world case studies to provide a clear background on the FCPA requirements and enforcement trends, along with practical compliance strategies to avoid prosecution.

The Foreign Corrupt Practices Act: Compliance Strategies is presented by Bethany Gilbert & Michelle Merola, of Hodgson Russ LLP. For more details please visit our site www.fxconferences.com

Implementing GMP for Combination Products: What Applies When?

For 10 years now FDA has been progressively developing its regulation of the complex product area known as combination products, with very few formal guidance documents for industry. Combination product manufacturers are faced with the challenge of deciding how to implement a quality system that is compliant with applicable Good Manufacturing Practices and Quality System Requirements.

In this audio conference, our speaker will discuss the applicable guidance and current thinking on meeting FDA expectations for combination products, sharing specific examples of accepted practices and how FDA regulations and guidance are currently being applied. The presentation will also examine the recent history of combination product approvals in the US, as well as important trends and issues for the future.

Implementing GMP for Combination Products: What Applies When? is presented by Linda Alexander, CEO & Co-Founder, Alquest, Inc. For more details, please visit our site www.fxconferences.com

A Practical Guide to Stress Management

"There cannot be a stressful crisis next week. My schedule is already full." - Henry Kissinger

Stress. It is a part of life. It cannot be avoided. For many, stress is perfectly manageable and taken in stride. Indeed, some even thrive on stressful situations, while for others it can become debilitating, impacting relationships, job performance and health. Book stores have entire sections devoted to stress and stress management, and the phone book is crowded with professionals who make a very good living trying to help people deal with stress. The fact is, most of us know what stresses us out, and we have a pretty good idea of how to reduce that stress. But knowing it and taking action are two very different things. This audio conference will present a layman's view of stress and stress management, identifying sources of stress and discussing the ways in which we can reduce the impact stress has on our everyday lives.

A Practical Guide to Stress Management is presented by Lindsay Gregory of ForeignExchange Translations. For more details on this audio conference, please visit our site www.fxconferences.com

Bulletproofing Personnel Policies Against Litigation

Are you concerned that your HR policies and processes might be leaving you vulnerable to lawsuits? No one sets out to create policy risks and personnel litigation. Yet every year a new crop of employee lawsuits are spawned by claims of inattention, inconsistency or unfairness in applying organization policies.

Learn how to avoid the costly loopholes in personnel policy and you could potentially save your company. This informative seminar helps you learn the basis of good policy and the importance of enforcing it consistently. There are basic rules you must know about workplace grievances and disciplinary issues to limit or avoid negative action altogether, especially litigation.

Grandma was right, you know. An ounce of prevention is worth a pound of cure.

Bulletproofing Personnel Policies Against Litigation is presented by Jay Rush, Director of Contracts & Legal Compliance, of Policy Technologies International. For more details please visit our web site www.fxconferences.com

Alternative Sites for Clinical Trials: Latin America

This is the third in a series of audio conferences featuring speakers from Covance discussing the benefits and pitfalls of using non-traditional sites for clinical research.

Conducting business in Latin America has proven beneficial to pharmaceutical companies by providing expanded patient access, including medically naive patients. This region also provides access to unique clinical indications. Business in the region continues to grow in spite of the many challenges that still exist and the regulations that continue to impact access to specimens in the different countries. In this audio conference, Conchita Delgado addresses these challenges and present solutions to overcome them.

Alternative Sites for Clinical Trials: Latin America is presented by Conchita Delgado, Manager, Latin America, of Covance Central Laboratories. For more details on this audio conference, please visit our web site www.fxconferences.com

Alternative Site Selection: China

This will be the second of two Covance audio conferences dealing with alternative site selection, and will focus on opportunities for the conduct of clinical research in China. This presentation will provide an overview of the current clinical research environment in China and explore reasons why China should be considered as part of global drug development strategies.

Alternative Site Selection: China is presented by Dr. Brett Bishop, Executive Director Operational Strategy & Planning, of Covance. For more details please visit our site www.fxconferences.com

Monitoring Essentials for International Medical Device Trials

The FDA publishes warning letters on its website, and these are increasingly concerned with the monitoring of medical device clinical studies. It is clear that some device manufacturers are finding it difficult to comply with the FDA's current guidance and regulations governing the monitoring of medical device clinical trials. In Europe, monitoring standards are similar but there is often a lack of clarity of what is expected because the audience for the clinical trial application (the competent authorities) and the CE marking dossier (the notified bodies) is different.

In this presentation, Dr. Helen Colquhoun will summarize the regulations and official guidance governing the monitoring of medical device clinical trials in the USA and EU. She will also provide the audience with the essentials necessary to ensure compliance with these regulations, including giving practical examples of what monitors need to do at site. Dr. Colquhoun will also cover how to deal with difficult investigators and sites that are unwilling to comply with regulatory standards. A discussion will follow on the consequences of non-compliance, as well as how to prepare for a monitoring audit by the FDA. Dr. Colquhoun will also discuss how clinical research departments need to be resourced to deal adequately with monitoring demands. The presentation will be illustrated by real-life examples.

Monitoring Essentials for International Medical Device Trials is presented by Helen Colquhoun, MD, CEO, Pleiad Devices. For more details on this presentation, please visit our web site www.fxconferences.com

Software as a Device: What You Need to Know About the New MDD

The current landscape of device regulations, as directed by the MDD, has undergone some substantial changes. The directive, published in April 2007, becomes a requirement in March of 2010. MDD: 93/42/EEC defines new regulatory challenges for device manufacturers groups and notified bodies, specifically in post market surveillance and vigilance.

It is time to start planning for the new requirements of the new MDD. Classification rules have been modified with some former devices now falling into higher class ratings, essential requirements have been changed, stricter definitions relating to medical devise, and more controls on software are jut some of the major changes.

Software as a Device: What You Need to Know About the New MDD is presented by Eric Henning, Sr. Project Manager, of KEMA. For more details on this audio conference, please visit our site www.fxconferences.com

Maximizing Productivity Among Spanish-Speaking Employees

On occasion, even when material and instructions are translated well, employers do not get the response that they need from Spanish-speaking employees. This happens not because of a lack of desire to be a valuable employee, but because of Spanish speakers’ misconceptions about what it takes to be a valuable employee in the United States.

In this audio conference we will address common challenges for employers---apart from the language barrier---and will offer various strategies for improving morale and encouraging desired behavior like compliance with training and regulation and participation in benefit plans.

This event is presented by Melissa Burkhardt of Futuro Sólido. To learn more, please visit www.fxconferences.com.

Writing & Designing for an International Audience

Are you responsible for generating content for global markets? Are you worried that the meaning in your message might be lost or altered because of cultural differences? Culture, translation, writing, and design interweave in curious ways when preparing content for an international audience. These elements require important skills for creating global content, especially given the increasing pressure to standardize and comply with various international and internal standards.

This presentation will highlight some key contradictions inherent in writing and designing for a multicultural and multilingual audience and discuss proven strategies for their resolution.

This event is presented by Nancy Hoft of Nancy Hoft Consulting. To learn more, please visit www.fxconferences.com.

Meeting the Challenges of Global Oncology Trials

Successful global oncology trials require careful planning, starting with looking at the strategic elements that span people, process and technology. Challenges in clinical research in oncology today include multiple new agents for multiple new targets combined with an increase in the number of patients needed to demonstrate that a therapy provides a significant benefit for patients. There is also a need to minimize the time it takes to go from basic science discoveries into clinical studies. The risk posed by delays in study start-up and patient recruitment can be mitigated by proactively planning for the study.

Planning needs to reflect the traditional and nontraditional considerations of feasibility and study design and incorporate trends and best practices. Patient recruitment is a key strategic consideration, along with epidemiological and genetic factors. Facilities, expertise and other resources along with technology play a key role in global trial planning.

Area-specific regulatory requirements vary in terms of standards of care, and differences among healthcare systems influence trial planning, as do local and cultural considerations.

This presentation will focus on the central challenges in global oncology trials today and make recommendations about how they might be addressed to mitigate risks in terms of timelines and costs.

This event is presented by Ute Berger of PRA International. To learn more, please visit www.fxconferences.com.

Medical Device and IVD Registration in China

China represents an attractive market for many mutinational companies due to two key elements: the dense population and huge consumer base; and the country's rapid economic growth. Due to the government policy of economic regeneration and the urbanization reshaping most regions, Chinese people are gradually becoming more affluent. As a result, there has been exponential growth in the medical device and IVD market in recent years. This phenomenon is similar to the drug industry in the early 90's.

The market potential for these two sectors is simply tremendous. Although there are different predictions and calculations from various experts regarding the market size of the medical device industry, a conservative estimate is over five billion US dollars. China is already the number two player in the Asia market and is just behind Japan in terms of volume. But while the potential is attractive, the registration process for medical devices and IVDs in China is quite lengthy, and the regulatory hurdles significant.

This presentation will provide an introduction to the regulatory environment in China, and the requirements and process for registering medical device and IVD products.

Medical Device and IVD Registration in China is presented by Janice Ma, Operations Director & Co-founder, of ChinaGate Ltd. For more details on this conference, please visit our site www.fxconferences.com

Predicting and Preventing Protocol Violations

Often, a large percentage of sponsor clinical trial budgets are allocated to remediation, focused towards fixing problems after they occur, rather than towards proactive activities which could help predict and prevent errors.

This presentation will discuss clinical trial protocol violations as a consequence of stressed "environmental" conditions at investigative sites, the potential risk for patient safety and the overall impact on the success of clinical trials. The speaker will examine why protocol violations are so pervasive, as well as conventional measures to handle them and their inability to adequately detect and address them. The presentation will look at Failure Mode and Effect Analysis (FMEA) as a proactive approach to predict and prevent protocol deviations/violations. The presentation will also discuss how clinical trial protocol violations are preventable within a risk management paradigm, and will outline a process for addressing protocol violations using the FMEA approach.

Finally, the presentation will address the implications to the sponsor's clinical trial budget of the proactive, predictive, prevention approach embodied by FMEA and how additional investment up-front can lead to improved clinical trial performance.

This event is presented by Brett Bishop of Covance. To learn more, please visit www.fxconferences.com.

Risk Management Strategies: US vs. EU

Does your company market its products in Europe, or are you planning to enter the EU market? Have you taken the requisite steps to address risk management? Risk management must be an integral part of global product development and commericalization.

In this audio conference, our speakers will compare and contrast the FDA and European Medicines Agency approaches to risk management. Dr. Stemhagen will focus on the US approache, while Dr. Blesse will provide an overview of EMEA's Guideline on Risk Management Systems for Medicinal Products for Human Use. We will also explore the epidemiological methods for post-authorization safety studies, and ways to reduce risk.

This event is co-presented by Annette Stemhagen of United BioSource Corporation and Stefan Blesse of Granzer Regulatory Consulting. To learn more, please visit www.fxconferences.com.

Best Practices for Back Translation as a QA Tool

Back translation is the translation of an already-translated text back into its original language. The use of back translation as a QA tool is becoming more prevalent in the life sciences industries, as often required by regulatory industries. These translated materials include product information, labels, informed consent forms, websites, software strings and a variety of other written content.

The issues presented by this growing trend in back translation are complex and often misunderstood by those removed from the localization process. Back translation as a QA tool can be successfully accomplished when these issues are fully understood and the process properly applied.

This event is presented by Hilary Davies of ForeignExchange Translations. To learn more, please visit www.fxconferences.com.