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 probability 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 approach embracing biological variation will be proposed.

Biomarker Data Interpretation and Challenges of Biological Variation was presented by Gordon F Kapke Ph.D., Sr. Director Biomarker Services, with Covance Central Laboratory Services and aired on 2009-01-28. For more details or to download this event, please visit our site at 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 or to download this event, please visit our site at www.fxconferences.com

Best Practices for Implementing ISO14971:2007

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com

Best Practices for Creating & Translating Global Content

Today, life sciences companies are experiencing tremendous pressure from regulatory bodies to conform to mounting numbers of industry standards. At the same time, they must always look to improve cost and time efficiencies and maintain the highest levels of quality and safety. All of these pressures present a daunting challenge for companies who then need to translate and localize critical information into multiple languages around the world. They can no longer rely on paper-based, manual business processes that are time consuming and error prone. Fortunately, new technologies are revolutionizing the functionality of translation management systems, improving a company's ability to manage and translate information into multiple languages through a set of seamless business processes and best practices.

In this presentation, we discuss globalization best practices to help your organization scale your global reach, growing your business and your bottom line.

Best Practices for Creating & Translating Global Content was presented by Steve Billings & Bill Rabkin, Idiom Technologies and aired on 2007-11-29. For more details or to download this event, please visit our site at www.fxconferences.com

Asian Clinical Trials: What to Know Before You Go

Thinking of conducting clinical trials in Asia?

Certainly more and more pharmaceutical companies are, and with good reason. The predominantly secondary healthcare environment, treatment-naïve patients and large population can mean less time to recruit and faster clinical development. Data quality is high, there are fewer competing studies, and the presence of large hospitals means more patients per site and dramatically reduced trial costs. But jumping on the Asian bandwagon without the proper forethought and knowledge could turn your trial into a tribulation.

Asian Clinical Trials: What to Know Before You Go was presented by Anthony Bishop, Quintiles East Asia and aired on 2004-07-27. For more details or to download this event, please visit our site at www.fxconferences.com

An Introduction to Translation Memory Technology

You've heard of translation memory, but what exactly is it? What can and can't it do for you and your company? And what's the difference between translation memory and machine translation?

This audio conference gives an overview of some of the translation memory systems on the market today, and introduce attendees to their main features -- like statistics, recycling of previous translations, and improved consistency through the use of TMs and terminology databases. The speaker also presents case studies highlighting the use and benefits of TM technology.

An Introduction to Translation Memory Technology was presented by Angelika Zerfass, Translation Tools Consultant and is previously recorded. To download this event, please visit our site at www.fxconferences.com

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference discusses the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study was presented by Michael Rosenberg, M.D., Ph. D., CEO, with Health Decisions and aired on 2009-02-18. To download this event, please visit our site 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 is previously recorded, and is available for download at www.fxconferences.com

21 Steps to Easier Globalization through Better Writing

Going global? Many of the problems encountered during the localization 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. Attendees will be able to put the conference material to immediate use in improving their technical literature.

21 Steps to Easier Globalization through Better Writing is previously recorded and is available to download at www.fxconferences.com

Regulatory Framework to Support Biomarker Development: EU & the USA

The European and US regulatory authorities recognize the potential of biomarkers to support the clinical and nonclinical development of medicinal products. Guidelines to clarify regulatory expectations have been published and both EMEA and FDA have developed procedures for companies to obtain input and advice on biomarker development. Importantly, those same regulatory authorities have both also formalized qualification procedures that result in an opinion on the acceptability/suitability of a biomarker.

This audio conference provides an overview of the EU and US biomarker qualification procedures. The speaker explains the steps involved, the data package required, and provides insight into why going through these procedures can add significant value with regards to investment opportunities, partnering and licensing deals.

Regulatory Framework to Support Biomarker Development: EU & the USA is being presented by Dr. Patricia Hurley, Head of Project Management and Biomarkers Division, with ERA Consulting (UK) Ltd. and airs on Thursday, January 21, 2010. For more details or to register, please visit our site at www.fxconferences.com

EU Medical Device eLabeling, Compliance & Software Requirements

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy. The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest proposed revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

EU Medical Device eLabeling, Compliance & Software Requirements is being presented by Salma Michor, CEO & Principal Consultant, with Michor Consulting EU and airs on Wednesday, January 13, 2010. For more details or to register, please visit our site at www.fxconferences.com

Post-Marketing Issues for Medical Device Companies

Mismanaged product recalls can prove to be a drain on a business’ resources and reputation, both of which can erode a company’s bottom line for years to come. Timely, effective product recalls, on the other hand, can strengthen an organization’s brand image well into the future. Inefficient medical device reporting also presents a clear and present danger. It can damage your company’s reputation and even threaten your ability to operate. So how should an organization alter the way it does business to guarantee that if post-market problems arise, it is equipped to quickly meet and resolve these issues?

This audio conference, conducted by Caryn M. Silverman, partner at Sedgwick, Detert, Moran and Arnold LLP, provides practical, step-by-step information that will help guide you through these challenging post-marketing processes. She defines and discusses medical device reporting, recall classifications and strategies -- as well as where and when exceptions to the rule apply -- Dear Doctor letters and post-marketing surveillance. This event airs on Wednesday, January 20, 2010, for more details please visit our site at www.fxconferences.com

ANDA vs. 505(b)(2): When and Why?

The cost of development and the uncertainty of regulatory review make the development of new drugs, and even new forms of older drugs, a risky proposition. Generic drugs can utilize the ANDA pathway or, with some allowed changes, the 505(j)(C) regulatory route. This simplifies the development process and greatly shortens the time to market for products that fit the definition. But what if your product cannot fit the generic definition for approval through an abbreviated pathway? In this situation, many companies employ a 505(b)(2) strategy.

This presentation is designed to help regulatory executives understand some of the nuances of these two regulatory pathways. Our speakers clarify the processes involved in the ANDA and the 505(b)(2), and examine the advantages and disadvantages of both.

ANDA vs. 505(b)(2): When and Why? is being presented by Joel Falk & Dr. Nick Fleischer, Executive Vice President & Vice President, with The Weinberg Group and airs on Thursday, January 14, 2010. For more details or to register, please visit our site at www.fxconferences.com

Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit

Regardless of the pharmaceutical development company, therapeutic area or regulatory pathway taken to get a drug onto the market, at some point there is a need to validate the business and scientific/regulatory case in a “proof-of-concept” clinical trial. If the development program supporting a proof-of-concept trial is done well, then it is up to the drug to demonstrate an acceptable risk-benefit profile.

In this audio conference, our speaker examines the framework necessary to maximize the chance of a successful proof-of-concept trial for a new chemical entity (the hardest case). The session also includes a discussion and case histories of the supporting nonclinical safety program, pharmacokinetic and pharmacodynamic evaluations, maximum tolerated dose issues, study design and endpoints in the context of a regulated industry.

Proof-of-Concept Clinical Trials: How to Maximize the Chances of Your Drug Demonstrating Benefit is being presented by Dr. Scott Oglesby, Director, Scientific Consulting, with Beckloff Associates, a Cardinal Health Company and airs on Tuesday, January 19, 2010. For more details or to register, please visit our site at www.fxconferences.com

Best Practices: Recording and Translating Audio for eLearning

Voiceover dramatically increases the impact of training programs, and has become ubiquitous in eLearning. While new technologies have lowered audio production and distribution costs in recent years, it remains an expensive component and must therefore be done right the first time. This can be critical when dealing with large amounts of audio files or multiple languages.

In this presentation, the speaker gives practical advice to streamline the different steps of audio production, both in English and in foreign languages: script preparation, voice selection, audio recording, post-production, file naming, linguistic quality assurance and more. Attendees on the media production side, as well as the localization side, learn valuable tricks to help them achieve higher quality, faster turnaround times and lower costs.

Best Practices: Recording and Translating Audio for eLearning is being presented by Xavier Marchand, Chief Operating Officer, with JBI Studios and airs on Tuesday, January 12, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

An Integrated Approach to Managing Supply Chain Risk

Supply chain integrity has never been a bigger or more complex challenge for today's global businesses. Increased pressure for improved financial performance, combined with the need to optimize assets and resources, has resulted in a growing reliance on outsourcing and offshoring, often to developing countries. However, with the benefit of reduced costs comes the increased and more complex threat of supply chain interruption. Efficient supply chains are by definition lean, stretched and fragile, resulting in an ever-present threat of breakdown. While most organizations prepare themselves for the more obvious areas of weakness, breakdown can come from unanticipated causes and all too often, traditional insurance products fail to provide any, or sufficient, financial help.

Many companies fail to appraise the full extent of supply chain vulnerabilities, and as a result, are not totally confident that risks are managed within acceptable financial targets. In this session our experts explain how an integrated model for the identification, treatment and acceptance of risk can address these concerns.

An Integrated Approach to Managing Supply Chain Risk is being presented by James Bird & Andrew Tait, Partner, Jardine Lloyd Thompson & Principal, Core Risks Ltd. and airs on Wednesday, January 27, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com

Overcoming Cultural Barriers to Global Marketing

Jean Monnet, the founder of the European Community, once declared, "If I were again facing the challenge to integrate Europe, I would probably start with culture." Culture is the context in which things happen. Whether you develop, market, sell or purchase products for a global audience or interact with people from around the world -- even if they work in the next cubicle -- you must address the issues of culture to be effective.

How and why do the needs of people from one country differ from those in a different country? How do you assess this? In this presentation we examine definitions of culture and consider how cultural differences are expressed. We will then explore the use of tools called cultural models, review the variables that define these models of culture, and weigh their usefulness. We also discuss how to develop a customized model of culture for your particular context.

Overcoming Cultural Barriers to Global Marketing was presented by Nancy Hoft, of Nancy Hoft Consulting and is previously recorded. To learn more or download this event, please visit our site at www.fxconferences.com

Contracts: Aligning Sponsor & CRO Interests

A primary objective for the outsourcing and procurement divisions of pharmaceutical and biotech companies is to select the best CRO to undertake their project and deliver it to success. A primary objective for the CRO is to deliver the project to success and earn repeat business with the Sponsor. Both parties' core objective is the same: to deliver the study to success. However, for both organizations it is essential that the business objectives are aligned and therefore, when entering into a Sponsor-CRO contractual arrangement, there are various elements of risk to be considered by both parties.

This presentation, the last in a three-part series on best practices for outsourcing, focuses on the components of managing both legal and financial risk through effective contracting.

Contracts: Aligning Sponsor & CRO Interests was presented by Lynn Polgar, Associate Director, US Contract Management Group, with Covance and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

Leveraging Clinical Development Opportunities in India

India presents a compelling environment for global clinical trials because of its access to investigators, large patient populations with diseases of the industrialized and developing world, a cost-effective, English-speaking graduate workforce, and progressive regulatory environment. These benefits are now well recognized by the global pharmaceutical industry. Moreover, because of India's pristine FDA audits, continued streamlining of regulatory approvals and demonstrated intent to uphold international intellectual property standards, the country has become even more attractive as an important locale for clinical development.

As a result, multinational pharmaceutical companies are striving to build clinical development capabilities within their local operating companies in India, and the country's nascent CRO industry is enjoying an annual growth of about 40%. This, however, poses resourcing constraints and unresolved ethical issues about the robustness of patient consent. Hence, it is becoming increasingly important for sponsors to select investigators, sites and resources that will be able to deliver data of the quality and integrity that they seek.

This presentation draws on recent experiences and case studies related to the benefits and challenges of conducting clinical trials as well as data management in India.

Leveraging Clinical Development Opportunities in India was presented by Dr. Nermeen Varawalla, Vice President, Investigator Relations, with PRA International and aired on 2007-05-30. For more details or to download this event, please visit our site at 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 was presented by Eunice Franklin-Becker, Project Manager, Registries and Observational Studies, with Covance Periapproval Services and aired on 2009-02-25. For more details, or to download this conference please visit our site at www.fxconferences.com

The ABCs of FDA: Regulatory, Fraud and Abuse Issues

More and more companies are venturing into medical devices, drugs or biologics in an effort to diversify or to promote new biotechnologies. At the same time, the United States government is taking a more active role in regulating the manufacturers, providers and payers in the healthcare industry. The collision of these two trends – increased interest in marketing healthcare products along with increased government involvement in regulation and enforcement – require companies to attain FDA regulatory compliance and prevent fraud and abuse violations in order to be successful in this industry and avoid multi-million dollar fines and penalties.

In this audio conference, the speaker addresses the basic things that people and companies need to know about dealing with the FDA and succeeding in the life sciences industry.

The ABCs of FDA: Regulatory, Fraud and Abuse Issues was presented by Bethany Gilbert, with Hodgson Russ LLP and aired on 2008-05-15. For more details, or to download this event please visit our site at 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 opportunities and 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 was presented by Michael van der Woude, Partner, with EDM Services and aired on 2008-10-21. For more details or to download this event, 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. Along with mandating the inclusion of medical device trials, additional requirements 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 requirements and responsibilities to comply with Title VIII, and the FDA is working to provide the answers and guidance.

In this audio conference, you will learn the latest information on registration of medical device trials and what you must do for compliance.

Registering Device Trials on ClinicalTrials.gov was presented by Amy Wise, Manager of Clinical Research, with PharmaNet and aired on 2008-11-13. For more details, or to download this event please visit our site at 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 was presented by Peter Simpson, President, of Segmedica and aired on 2008-11-12. For more details or to download this event, please visit our site at www.fxconferences.com

Industry Update: EU Labeling for Medical Devices

Many companies believe that by simply having the CE mark on their products they are in position do business in Europe. However, things are not always that straightforward. They tend to forget that the European Union is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with national language requirements. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

This audio conference discusses these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels. In addition, the presentation covers proper language for the intended users in conjunction with risk management.

Industry Update: EU Labeling for Medical Devices was presented by Dr. Jaap Laufer, Vice President, Public & Regulatory Affairs, with Emergo Group and aired on 2009-03-12. For more details or to download this event, please visit our site at www.fxconferences.com

Device Design in the Current Regulatory Climate

The current regulatory environment is dominated by post-market issues. Recent high-profile drug recalls have caused physician groups, Congress, the press and FDA to take new interest in post-market issues. To survive and prosper in this environment, medical device designers must recognize and accept several key truths.

Unlike drug molecular design, device design is an evolving process, not a one-time event. Also, a medical device is not just hardware, as the product labeling determines its use and its regulatory status. The associated service and customer care can make the difference between success and failure. Therefore, each post-market event causes you to look back into your design process; how far back and in what detail to do so are the key process issues.

This presentation discusses the increase in post-market scrutiny, how it came about, and how device designers can best deal with it.

Device Design in the Current Regulatory Climate was presented by Robert J. Klepinski, with Fredrikson & Byron and is previously recorded. For more details, or to download this event please visit our site at www.fxconferences.com

Conducting Drug Trials in Central & Eastern Europe

Over the next several months, ForeignExchange will present a series of audio conferences featuring expert speakers from Covance discussing the key benefits and drawbacks of using non-traditional sites for conducting clinical research.

In this first first presentation, we focus on the opportunities present in Central and Eastern Europe. This presentation will highlight the current status of the health care system in this region, and how it creates a propitious environment for clinical research business development, boasting rapid recruitment and high quality data.

Conducting Drug Trials in Central & Eastern Europe was presented by Dr. Malgorzata Szerszeniewska, Director of Strategic Development, Central & Eastern Europe, with Covance and is previously recorded. To download this event, or for more details please visit our site at www.fxconferences.com

Design and Regulatory Considerations in Anti-Infective Drug Development

The current regulatory environment in anti-infective drug development is changing due to updates in submission requirements as well as the potential for risk mitigation strategies post-launch. Conversely, the need to develop drugs with acceptable risk/benefit profiles for emerging and re-emerging infectious diseases is certainly present considering the rising concerns of disease due to drug-resistant pathogens, biothreat agents and novel influenza strains.

In this conference our speakers review some of the basic principles surrounding anti-infective drug development in the framework of regulatory submissions. They also provide an update on some of the most important changes in recent years related to specific anti-infective indications.

Design and Regulatory Considerations in Anti-Infective Drug Development is being presented by Dr. John Powers, George Washington University School of Medicine & Dr. Carl Kraus, PRA International and airs on Wednesday, December 16, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Considering Human Factors in Designing Medical Device Trials"

Increasingly, FDA is requiring that clinical evaluations take into account human factors and their effects on device design. It is becoming more important to address how these affect the safety, performance and reliability of medical device use to ensure appropriate device design.

Evaluating the human interface in the user environment produces critical data for pre-market applications to FDA. However, medical device trials intending to collect these unique data must be carefully designed to bring the most valuable data to light.

In this audio conference the speaker looks at various human factors which must be taken into consideration when designing a medical device clinical trial, and uses a series of real-life examples to illustrate how best to incorporate them into the design process. In addition, all attendees will receive a copy of Pleiad's Human Factors Considerations checklist.

But hurry! If you purchase Considering Human Factors in Designing Medical Device Trials by November 26, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Clinical Investigations in Asia

Managing clinical studies in Asia can be both rewarding and challenging, as researchers face such issues as language, regulatory requirements and logistics. However, delays and frustrations can also arise if local practices -- such as standard treatments, insurance and reimbursement, indemnification of sites and investigators, and administration of study grants -- are not considered and anticipated. In addition to a well-structured feasibility study which provides meaningful information and data, the unique considerations of "locality" and corresponding solutions would be of value.

Whether or not a sponsor engages a CRO for Asian studies, it is important that they thoroughly understand the differences, the uniqueness (what and why things are done the way they are in Asia), and the latest on the local regulatory fronts, in order to assemble a solid and achievable clinical management plan.

Focused on China, Taiwan, Hong Kong, South Korea, Japan, Thailand and Singapore, this presentation draws on the benefits and challenges of managing clinical trials in Asia, based on recent experiences. The speaker also addresses critical points to ensure successful project start-up and conduct.

Clinical Investigations in Asia was presented by Edward C. Ian, Director of Operations in Asia, with PRA International and is previously recorded. For more details or to download this event, please visit our site at www.fxconferences.com

ForeignExchange Translations provides specialized Korean, Japanese, and Chinese translation services to medical device and pharmaceutical companies.

Building Better Business Relationships

Relationships are fundamentally critical to business success. However, most individuals and organizations lack the number, quality and level of relationships to achieve their goals and have no effective way to address this critical problem. With the right mindset, process, skills and best practices, individuals and organizations can dramatically improve the productivity and speed at which they build business relationships and achieve critical business outcomes. In this high-energy session, you learn to apply proven techniques that will help you rapidly develop, deepen and manage the relationships that are most important to your success.

Building Better Business Relationships was presented by Dr. Jeff Kaplan, Director of Leadership Development & Training, with Ferrazzi Greenlight and aired on 2009-04-02. For more details or to download this event, please visit our site at www.fxconferences.com

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study

Adaptive methods are increasingly used for statistical issues in research, but this limited use overlooks the most powerful and sustained advantages: application of the same adaptive principles to how a study is run. This approach focuses on continuous measurement and refinement of key study metrics that include rapid enrollment, reduced waste, lowering monitoring costs, and quick study conclusion and database lock. Compared to traditional approaches, adaptive methods typically enable 20% faster enrollment, 20-80% lower study query rates, 20-60% lower monitoring costs, and 50% faster database locks.

This audio conference will discuss the tools and processes essential to this approach, along with design and planning issues and net financial impact on Net Present Value and Internal Rate of Return.

Adaptive Clinical Trials: How Advanced Adaptive Methods Can Improve Your Next Study was presented by Michael Rosenberg, M.D., Ph. D., CEO, with Health Decisions and aired on 2009-02-18. For more details or to download this event, please visit our site at www.fxconferences.com

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance

On August 6th, FDA Commissioner Margaret Hamburg outlined the agency’s new enforcement strategy and her plan for creating “a strong FDA.” With greater scrutiny and a more streamlined enforcement process, it is critical that firms be prepared to respond and take corrective action quickly upon receiving a warning letter. This audio conference is designed to help senior life science executives understand what the new strategy means to them, how to maximize the chances that an FDA inspection will not trigger additional agency enforcement action and, if it does, how to respond.

FDA's New Enforcement Strategy: The Growing Perils of Inadequate Compliance is being presented by Matthew Weinberg & Michael Swit, CEO & Vice President, with The Weinberg Group and airs on Wednesday, December 9, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Device e-Labeling & Regulatory Compliance in the EU"

Medical device labeling in the EU continues to pose a challenge for manufacturers, who must create compliant Instructions for Use in all required languages. Currently, most Instructions for Use are provided in paper format, which can be very lengthy.

The term "e-labeling" refers to innovative means for providing Instructions for Use in an electronic format for medical devices. This is especially the case with IVDs, since these are usually used by healthcare professionals in a clinical environment, with relatively common access to computers and Internet facilities.

However, the latest revisions to Directive 93/42/EEC and Directive 90/385/EEC introduce an amendment to an annex of the directives that will be pivotal for e-labeling, and also for Class IIb and Class III devices. In this audio conference, we look at some of the labeling-related compliance issues faced by medical device manufacturers and the advantages of using e-labeling.

But hurry! If you purchase Device e-Labeling & Regulatory Compliance in the EU" by November 19, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

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 conference, 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 the second edition, changes you need to know about 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 is being presented by Leo Eisner, Product Safety & Regulatory Consultant, with Eisner Safety Consultants and airs on Wednesday, November 18, 2009. For more details or to register, please visit our site at www.fxconferences.com

The Art and Science of Drug Product Regulatory Submissions

Collectively, pharmaceutical drug products include a surprisingly wide variety of possible dosage forms and functions. No matter the dosage form, there are requirements that must be met in manufacturing and testing. A high-quality, organized CMC submission should be organized based on the CTD format, and contain information that will aid in a positive review and a quality drug product for patients. Fortunately, there are many similarities across this wide variety of dosage forms, including general product development principles which can be utilized throughout the life of any drug product.

This session provides an overview of the similarities -- and some unique differences -- of manufacturing, analysis and regulatory expectations. Our speaker explains how these similarities can fit together to produce a high-quality submission to the FDA for marketing approval, as well as regulatory maintenance after approval.

The Art and Science of Drug Product Regulatory Submissions is being presented by Dr. Andrew Trammel, Director, Executive Consultant, with Beckloff Associates and airs on Tuesday, December 8, 2009. For more details or to register, please visit our site at www.fxconferences.com

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times

What do you want others to say of your leadership during these challenging times? When the going gets tough, thanks to conditions such as dropping revenues and profits, mergers and acquisitions, re-organizations or shrinking pipelines, there is an opportunity for leaders to step up and stand out. It is also a time to step back for a little self-reflection on just what are the leadership requirements for this “new normal” of organizational life.

Based on over 20 years of experience working with such companies as Pfizer, Sanofi-Aventis, Biogen Idec and Boehringer Ingelheim, in both research and commercial divisions around the world, Lynda McDermott provides attendees with “best practice” leadership learnings and tools to help you and your people “stay in the game."

Stay in the Game: Leading Pharma and Biotech Teams in Tough Times is being presented by Lynda McDermott, President, of EquiPro International and airs on Thursday, December 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices

With health care reform on the horizon, the business case for quality and efficiency in health care has never been clearer. The new system will encourage payers to reimburse only for consistent and efficient care. Increasing transparency will make it easier for patients, who will in turn demand care that meets their needs. Preparing for the future of health care is therefore critical to the survival of many organizations. This changing health care landscape will have implications for medical providers and suppliers alike.

This session provides an overview of health care reform by understanding Massachusetts reform as a likely model. Dr. John Freedman outlines how such changes are likely to impact clinicians, as well as medical suppliers. This includes outlining key macro trends related to performance measurement, improvement, efficiency and cost containment.

Cost & Effectiveness: Healthcare Reform and its Implications for Pharma & Devices is being presented by Dr. John Freedman, Principal, of Freedman HealthCare, LLC and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "GCP for Medical Device Trials: Upcoming Revisions to ISO 14155"

An important standard for conducting medical device research is changing. How will it affect you?

Conducting global clinical trials in accordance with recognized standards provides improved assurance that clinical trial data will be accepted to support global marketing authorization applications. ISO 14155 (clinical investigation of medical devices for human subjects - Parts 1 and 2) is currently under revision.

This audio conference focuses on the status of revisions to ISO 14155, anticipated changes to the standard, and acceptance of the standard by regulatory authorities. This presentation reviews the required clinical investigation elements presented under ISO 14155 and provide tools for integrating the standard into your clinical research quality system.

Participants also receive a medical device clinical research map comparing requirements of ISO 14155 (2003) Parts 1 and 2, the draft revised ISO 14155, and FDA 21CFR 820. The speaker also provides attendees with an essential clinical investigation document checklist.

But hurry! If you purchase GCP for Medical Device Trials: Upcoming Revisions to ISO 14155 by November 12, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Protecting Data Under Current EU Pharma Legislation

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.

Protecting Data Under Current EU Pharma Legislation was presented by Dr. Ulrich Granzer, with Granzer Regulatory Consulting & Services and aired on 2006-12-14. For more details or to download this event, please visit our site at www.fxconferences.com

Comparative Effectiveness Research: Threat or Opportunity?

Comparative effectiveness research (CER), a prominent component of legislative and regulatory efforts to rationalize the use of health care resources, improve outcomes and constrain the explosive growth of health care spending, is widely perceived as a financial threat by medical technology and pharmaceutical companies. During the current healthcare reform debate, industry has supported stringent limits on payers’ use of CER results in an effort to minimize its impact. But CER also has the potential to define new market opportunities for existing technologies and to open new pathways for the introduction of innovative diagnostics and therapeutics. Opposition to CER initiatives may foreclose significant growth potential for industry.

This presentation explores how CER is likely to be implemented, analyzes the nature of the threat posed by CER to the commercial status quo, and evaluates the opportunities that a robust implementation of a CER program would create.

Comparative Effectiveness Research: Threat or Opportunity? is being presented by Dr. Edward E. Berger, Principal and Founder, Larchmont Strategic Advisors and airs on Thursday, December 3, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Trial Success in Latin America

Latin America has proved to be a solidly performing region for clinical trials, catching the interest of global pharmaceutical and biotech companies. GCP (Good Clinical Practice) has been adopted as local regulatory requirement in most Latin American countries over the last decade. Since then, industry-funded clinical research has grown rapidly, and Latin America is routinely considered for global drug development programs. The reasons for this growth are simple: a large patient population, solid investigators with experience in clinical research, well-equipped qualified study institutions, strengthened clinical research infrastructure (laboratories, drug depot services and logistics), and internationally recognized standard treatments.

This audio conference reviews the major factors that have made Latin America a successful region for global clinical research studies. Drawing on recent experiences, the speaker outlines the benefits and challenges to managing Latin American clinical trials, while sharing practical advice on critical points to take into account when conducting trials in Latin America.

Clinical Trial Success in Latin America is being presented by Dr. Frederico Lerner, Senior Director of Operations, with PRA International and airs on Friday, November 13, 2009. For more details or to register, please visit our site at www.fxconferences.com

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit

Successfully implementing EDC depends on having processes in place that take advantage of the technology. Although it is generally possible to use EDC with processes that were designed for paper case report forms, there are many ways EDC can be integrated into the clinical trial process to make it more efficient, and depending on the goals for EDC, there are many metrics that can be captured to help establish benefits. Among these are cycle time for resolving queries, use of standards, quality of data, cost per form or datapoint, time between last patient visit and database lock.

This conference explores how processes related to EDC can be integrated into clinical trial processes for creating and deploying case report forms, as well as monitoring and managing trials. Our speaker shares insights on how to use lean concepts to look at the processes you have, identify opportunities for improvement and show measurable progress.

EDC Front to Back: Integrating Clinical Trial Data for Operational Benefit is being presented by Ross Rothmeier, Senior Director, EDC Portfolio, Clinical Development Services, with Covance and airs on Tuesday, November 17, 2009. For more details or to register, please visit our site at www.fxconferences.com

Communicating Policies & Procedures for the 21st Century Organization

Are your organization’s policies and procedures (P&P) out of date, unclear or inconsistent? Are you still reading and writing P&P in paragraphs with academic outlines accessible in dusty binders or in PDFs? This presentation introduces you to P&P communication as a body of knowledge, while exploring the latest trends and best practices for developing and managing P&P systems and information -- thus transforming performance for the 21st Century organization.

Led by a leading expert in P&P communication, this highly engaging presentation is filled with insights, anecdotes, resources and examples on and about policies and procedures.

Communicating Policies & Procedures for the 21st Century Organization is being presented by Raymond Urgo, Principal, with Urgo & Associates and airs on Wednesday, December 2, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Hazard Analysis for Medical Devices Under IEC60601 and ISO14971"

If you have participated in hazard analysis meetings, you have probably spent hours discussing whether a scenario is a hazard, or the cause of a hazard, or debating whether the probability of an unmitigated hazard is high or low, or went off on a tangent evaluating very unlikely hazard scenarios, or wrestled with group members who consider hazard analysis meetings a waste of time.

This presentation looks at what is required under IEC60601 and ISO14971, and provides guidance on how to motivate groups to perform hazard analyses, structure meetings effectively and make them meaningful. It discusses documentation formats and hazard evaluation strategies, as well as presenting ideas on how to get the most benefit out of the risk management process.

But hurry! If you purchase Hazard Analysis for Medical Devices Under IEC60601 and ISO14971 by November 5, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Developing a Post-Approval Labeling Risk Management Strategy

Patient injured because of event described in black box warning: Company still liable, long established FDA approved warnings not sufficient...

Patient injured on generic drug: innovator company could be liable for inadequate warnings...

FDA-approved labeling is no longer a regulatory and liability safe zone. Companies face rapidly escalating FDA, product, reimbursement and patent liabilities tied to labeling management. Penalties, damages and fines are hitting billion-dollar-plus levels, with consideration of direct liability for executives being openly discussed. Traditional labeling development and management approaches that center on FDA approval and adverse event reporting are not up to the task of protecting companies and their executives. This audio conference explains what has happened over the last year and likely changes for the coming years and what to do now to position products for success and avoid liability or regulatory disaster.

Developing a Post-Approval Labeling Risk Management Strategy is being presented by Gary Gamerman, President, of Seraphim Life Sciences Consulting LLC and airs on Tuesday, December 1, 2009. For more details or to register, please visit our site at 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.

Maximizing Productivity Among Spanish-Speaking Employees was presented by Melissa Burkhardt, President, of Futuro Sólido and aired on 2008-02-13. For more details or to download this event, please visit www.fxconferences.com

To learn more about Spanish translations, please visit ForeignExchange Translations' web site.

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 presented by Dr. Stefan Blesse, with Granzer Regulatory Consulting and aired on 2007-07-19. To download this event, or for more details please visit our site at www.fxconferences.com

An Introduction to Analyzing Risk in Medical Devices

Medical device technology has become so advanced and diverse, it is extremely challenging to identify and anticipate all risks. Risk analysis is a regulatory requirement in which a medical device manufacturer is to identify a complete, unbiased picture of all possible hazards that could potentially be created by a device and design plans to avoid, mitigate, or control these hazards. The science of risk analysis and documentation of a risk management plan must incorporate the objective identification of defects or failures along with the subjective determinations of likelihood, severity, and acceptable risk limits during the entire life cycle of the medical device. This audio conference will provide an overview of risk analysis for medical devices, including information on the various international regulations with which manufacturers must comply.

An Introduction to Analyzing Risk in Medical Devices was presented by Amy Wise, Manager, Clinical Research, with PharmaNet and aired on 2008-07-31. For more details, or to download this conference please visit our site at www.fxconferences.com

Friday special - save 75% on "Pre-IDE Submissions and Meetings: Best Practices"

Companies that develop medical devices today have the option of informally meeting with the FDA staff in what is called a "pre-IDE meeting." This meeting will ultimately review their marking application in order to gain clarity about the agency’s expectations regarding the preclinical and clinical testing requirements for their device. In most cases, it is critical to take advantage of this opportunity.

This presentation describes how to optimize the pre-IDE submission of information to FDA, as well as the meeting that follows this submission, in order to maximize the information derived and facilitate your device development plan.

But hurry! If you purchase Pre-IDE Submissions and Meetings: Best Practices by October 29, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

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.

Best Practices for Back Translation as a QA Tool was presented by Hilary Davies, Senior Project Manager, with ForeignExchange Translations, and aired on 2008-08-06. For more details or to download this conference, please visit our site at 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.

The topics covered will include successful strategies for the transport of cold chain including regulatory and import considerations. Also discussed will be aspects of clinical sample logistics including site and lab selection, and customs.

Global Clinical Studies: Logistical Challenges from Supply to Assay was presented by Karen Oliver, Director Global Accounts, with World Courier and aired on 2008-10-08. For more details or to download this audio conference, please visit our site at 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 also addresses general topics such as vigilance requirements, language and the operational process of conducting trials in the EU and USA.

Medical Device Clinical Evaluations: EU vs. US was presented by Helen Colquhoun, MD, CEO, with Pleiad Devices. For more details, or to download this event please visit our site at www.fxconferences.com

To learn more about German Translations, please visit ForeignExchange Translations website at www.fxtrans.com

Optimizing Preclinical Data for Medical Device Submissions to FDA

When preparing medical device submissions for FDA, it pays to get it right the first time. Not only are mistakes costly in terms of time and money, but they can leave a lasting and unfavorable impression on FDA. Fortunately, there are abundant resources available to help sponsors optimize their preclinical submissions.

In this audio conference, we look at the most common errors sponsors make when submitting preclinical data for medical devices to FDA, and how best to avoid them. Areas discussed include: using and justifying clinically relevant acceptance criteria, testing under appropriate conditions, optimizing study design, justifying protocol deviations, selecting appropriate test models, writing test reports with FDA in mind, providing adequately detailed descriptions, justifying sample sizes, including raw data, ensuring submission quality through proofreading, and clearly articulating intended use.

Optimizing Preclinical Data for Medical Device Submissions to FDA is being presented by Dr. Elisa Harvey, Senior Regulatory Consultant, with CardioMed Device Consultants and airs on Thursday, November 19, 2009. For more details or to register, please visit our site at www.fxconferences.com

Preparing to Translate: Tips for Faster, Easier, Cheaper Localization

We live in the era of globalization, when people are accustomed to dealing with colleagues and companies all over the world. and yet language barriers are still creating obstacles and challenges. In the life sciences and other industries where accuracy of information is paramount, getting your content to cross language boundaries flawlessly is still a difficult and often costly endeavor. Language will always have a human dimension, and communicating from one country or culture to the next requires planning, preparation and forethought. However, a little preparation can go a long way towards helping your company achieve substantial cost savings in the global market.

In this conference our speaker, veteran translation industry expert Sandra La Brasca, gives advice on how to prepare your materials for translation. She also illustrates how writing for translation ultimately results in cheaper, faster, more accurate global products.

Preparing to Translate: Tips for Faster, Easier, Cheaper Localization is being presented by Sandra La Brasca, Solutions Development Director, with ForeignExchange Translations, Inc. and airs on Tuesday, November 24, 2009. For more details or to register, please visit our site at www.fxconferences.com

Maximizing the Performance & ROI of Patient Recruitment Materials

It goes without saying that being able to communicate effectively with subjects is paramount in the world of patient recruitment. It is critical to have the necessary tools to ensure you are getting the most out of your global patient recruitment communication materials. This session reviews the established methodologies for accurately measuring the reading level of materials and addresses the impact of design and font elements on readability. Key cultural considerations are also discussed.

In this audio conference, our speaker examines the latest patient insights and presents principles for optimizing clinical trial communication pieces. Utilizing real-life examples, she also provides best practices for ensuring that recruitment materials retain their ability to convey compelling messages as they pass through the regulatory review process.

Maximizing the Performance & ROI of Patient Recruitment Materials is being presented by Mary Schwarz, Vice President, Core Services & Operations, with MMG and airs onWednesday, November 11, 2009. For more details or to register, please visit our site at www.fxconferences.com

Friday special - save 75% on "Risk-Based Software Validation for Medical Devices"

It isn't glamorous, and sometimes it isn't even considered a core competency necessary for our business. But in the medical device industry, software validation often consumes a huge portion of the budget for new software products, even when that wasn't the original intent. Unfortunately, software testing methods haven't kept pace with innovations on the product development side. Just as we look to new and improved ways to complete software development, medical device companies also need to be looking for new and improved ways to validate that software.

This audio conference examines the various approaches to software validation, and discusses how and why to consider risk as part of the validation process. The presentation also looks at ANSI/AAMI/IEC 62304:2006 Medical Device Software - Software Lifecycle Processes, and how it uses risk to drive software verification and validation.

But hurry! If you purchase Risk-Based Software Validation for Medical Devices by October 22, 2009, you can enter coupon code FXC75%OFF and save 75% of the regular purchase price.

Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality

A cornerstone of the translation industry is the quality of the linguistic work completed, yet linguistic quality remains nebulous for many end clients and translation suppliers. Linguistic quality means different things to different organizations and for different types of projects. With lack of measurable quality systems comes the need to add steps to the process to “ensure” quality. This perceived increase in quality (more people looking at the text) results in slower time-to-market and increased costs.

This audio conference looks at how to move from an uncertain quality outcome to measurable, predictable quality, while presenting an approach to defining, measuring and improving linguistic quality within an organization. The speaker also discusses how to utilize these measurements to meet the organization’s business objectives on a broader scale, spanning improvements in cost and time-to-market.

Bridging the Linguistic Quality Gap: How to Measurably Improve Translation Quality is being presented by Sonia Monahan, Executive Vice President, Quality Systems, with ForeignExchange Translations, and airs on Tuesday, November 10, 2009. For more details or to register, please visit our website at www.fxconferences.com

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan

The End-of-Phase 2 FDA meeting is the optimum time to obtain FDA input at a single Type B meeting on the remaining pharmacology and toxicology studies, chemistry manufacturing and controls (CMC) of the clinical formulation, and the overall IND clinical plan to support an NDA submission for market approval. Therefore, it is essential to give proper forethought and attention to the all-important steps in preparing for the EOP-2 FDA meeting.

In this conference our speaker, veteran industry expert Dr. Larry Hofmann, gives expert guidance on the optimum background and makeup of your EOP-2 FDA meeting team. He also discusses strategic planning for and preparation of the FDA meeting information package, which must include available pharmacology and toxicology, Phase 1 and Phase 2 study summaries, as well as a summary of CMC data on the previous IND clinical formulations and proposed Phase 3 formulation to support the proposed Phase 3 and remaining Phase 1 study protocols.

FDA End-of-Phase 2 IND Meeting: Finalizing the IND Clinical Plan is being presented by Dr. Larry Hofmann, President, of LMH Associates, Inc. and airs on Tuesday, November 3, 2009. For more information, or to register for this event please visit our site at www.fxconferences.com

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine

In the ever-expanding market of clinical trial supply, the challenges are becoming more and more complex. This is particularly true of the increasingly popular, but still developing, emerging market countries. This session focuses on four emerging market locations -- China, Brazil, Russia and the Ukraine -- that can pose many obstacles for logistics professionals. Our speakers share insights into country regulations, potential pitfalls during the importation process, and the potential effects on the cold chain that these mistakes may cause.

In this audio conference, our speakers also identify the most common denominators that can impede clinical supply chain distribution, while sharing their experiences and the actions taken to find solutions in this complex arena.

Clinical Trial Supply Challenges in China, Russia, Brazil & the Ukraine is being presented by Karen Oliver & Tracci Gilchrist, Director, Global Accounts & Manager, International Issue Resolution, with World Courier and airs on Thursday, November 12, 2009. For more details or to register, please visit our site at www.fxconferences.com

To learn more about Brazilian Portuguese translations, please visit ForeignExchange Translations website by clicking here

A Systematic Approach to Japanese Medical Device Submissions

Planning to take your products to Japan? Japan represents an 18-billion-dollar market for medical device manufacturers, and 40% of that is imports. However, entering the Japanese marketplace requires careful forethought and planning.

In this audio conference we provide an overview of the regulatory process in Japan including detailed timelines, cost estimates, and common mistakes made during market entry. The first part of the presentation will focus on the time and cost associated with a Japanese device submission, as well as outlining the steps needed to prepare for a submission. In the second part, our speaker discusses the initial steps of any Japanese submission and explains the difference in device classifications and approval categories. From there, we move on to common pitfalls and shortcomings of most foreign device submissions. This will include a detailed look at the different data and analysis needed, as well as a cultural section on dealing with Japanese reviewers, market authorization holders (MAH) and distributors.

A Systematic Approach to Japanese Medical Device Submissions is being presented by Michael Halper, President, of Small World Medical and airs on Tuesday, November 10, 2009. For more details or to register for this event, please visit our website at www.fxconferences.com

To learn more about Japanese Translations, please visit ForeignExchange Translations website at www.fxtrans.com

Achieving Compliance and Beyond with Simplified Technical English

Even the best product is only as good as its documentation and technical data, which allow the customer to use it safely and effectively. Simplified Technical English (STE) can help you meet documentation compliance requirements, and can also increase the efficiency and productivity of your employees. Formerly known as AECMA Simplified English, STE is an international standard (ASD-STE100) that helps to make technical documentation easy to understand and easier to translate for global customers. Simplified Technical English standardizes vocabulary, grammar and style, while letting users control their specific terminology.

In this session, Dr. Frans Wijma highlights some of the key benefits and rules of STE that can help to address 99% of the main challenges behind documentation processes, such as high cost, ease of translation, damage to product, delayed time-to-market and inadequate customer support.

Achieving Compliance and Beyond with Simplified Technical English is being presented by Dr. Frans Wijma, Managing Director, with Shufra and airs on Tuesday, November 3, 2009. For more details, or to register please visit our site at www.fxconferences.com

Studies in Special Patient Populations: More than Just a Regulatory Requirement

In global drug development, supportive trials -- such as those in special patient populations -- are required to complement the regulatory submission package. Studies in hepatically or renally impaired patient populations are therefore often performed in parallel to Phase III trials in order to have them completed when the NDA is filed. However, in aging populations with reduced organ function, these studies can provide valuable information on interpretation of clinical data generated in Phases II and III.

In this audio conference, the speaker discusses the strategic and organizational aspects of these trials, while providing a deeper understanding of their value in special patient populations.

Studies in Special Patient Populations: More than Just a Regulatory Requirement is being presented by Dr. Christian Reh, Vice President, Clinical Affairs, Early Development Services, with PRA International and airs on Thursday, October 29, 2009. For more details or to register for this event, please visit our site at www.fxconferences.com

Navigating State Sales & Marketing Laws for Drugs & Medical Devices

Marketing your pharmaceutical product or medical device while adhering to ever-changing state and federal laws can pose a signifcant challenge. For example, on March 11, 2009 the Massachusetts Department of Public Health issued requirements similar to those of other states, imposing restrictions on pharmaceutical and medical device manufacturers’ sales and marketing activities. This session looks at current state laws regulating the sales and marketing practices of pharmaceutical, biotech and medical device companies, with a particular emphasis on the new requirements in Massachusetts and Vermont.

In this conference, our speaker examines the federal legislation that regulates pharmaceutical and medical device sales and marketing, while also providing insight into how companies can develop compliance plans to take into account the "patchwork" of state laws, applicable federal laws and industry guidance.

Navigating State Sales & Marketing Laws for Drugs & Medical Devices is being presented by Maria D. Buckley, with Nutter McClennen & Fish LLP and airs on Wednesday, November 4, 2009. For more details or to register to attend this event, please visit our site 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 was presented by Melissa Burkhardt, President, of Futuro Sólido and aired on 2008-05-28. For more details on this conference, or to download it please visit our site at 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 was presented by Geert Langendries, with Covance IVRS Project Management Group and aired on 2007-12-05. For more details or to download this audio conference, please visit our site at www.fxconferences.com

Designing Web Sites for International Users

When it comes to building and maintaining international Web sites, many companies suffer from an English-centric world view. Neglecting global markets with your site, means you risk alienating potential customers and forgoing revenue opportunities. Whether your company is international "from the ground up" or selling products into select markets, it can benefit from a well-implemented global Web strategy.

This audio conference helps you successfully manage the daunting task of designing and maintaining a high-quality international Web presence.

Designing Web Sites for International Users was previously recorded and presented by Andres Heuberger, President, of ForeignExchange Translations. For more details, or to download this conference please visit our site at www.fxconferences.com

Best Practices for Building Global eLearning Programs

e-learning: One day you love it, the next you hate it. Where would you be without it, yet you curse it.

In order to reach and teach an increasingly diverse employee population, companies are adapting their e-learning programs. Designing, building, and deploying e-learning programs is hard enough for one culture - it becomes much harder when the audience doesn't all speak English or isn't all located in one country.

In this audio conference, we present how to apply good program design principles. Not only will you be able to maximize your e-learning investment, but by following best practices in conceptualizing and building your programs, you guarantee efficient training for today’s diverse employee population.

Best Practices for Building Global eLearning Programs is previously recorded and was presented by Eoghan O'Maolain, Director of eLearning Development, with Rendition Digital. For more details on this audio conference, please visit our site at www.fxconferences.com

Optimizing Country Selection for Clinical Research

A number of elements can influence decision-making when developing a global footprint within the clinical research environment. These elements include: knowledge of the regulatory framework and timelines, suitability of the healthcare setting, compatibility of standard of care, interest within the physician community, internal resource availability to train sites and monitor high quality data, and the competitive landscape.

In this presentation, Dr. Stansfield discusses these elements, with a primary focus on the ways that patient access can influence the successful outcome of clinical research for a new product. She also highlights the pros and cons of different approaches.

Optimizing Country Selection for Clinical Research was presented by Susan Stansfield, PhD, Executive Vice President Product Registration Europe, Africa & Asia Pacific, with PRA International and aired on 2008-02-14. For more details, or to download this conference please visit our site at 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, Fredrikson & Byron and aired on 2007-01-18. For more details, or to register please visit our site at 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 was presented by Nancy Hoft, with Nancy Hoft Consulting, and is previously recorded. For more information, or to download this conference please visit our site at www.fxconferences.com

EU Device Labeling: Issues and Requirements

For many companies, achieving ISO 13485 certification, applying the CE mark and finally exporting to Europe is a great victory. However, many companies forget that the EU is made up of 27 separate countries (Bulgaria and Romania being the newest members) and underestimate the complexity of dealing with language requirements and the use of symbols for each country. Will Germany allow English labeling for devices used only by a professional? Does Belgium require Dutch, French or German -- or all three?

In this presentation, we discuss these issues and also cover the use of symbols in packaging, instructions for use (IFU) and device labels.

EU Device Labeling: Issues and Requirements was presented by Dr. Jaap Laufer, .P. Public & Regulatory Affairs, with Emergo Group Inc. and aired on 2007-09-06. For more details, or to download this audio conference please visit our site at www.fxconferences.com

505(b)(2) Submissions: Eligibility, Strategies & Preparation

There are a variety of scenarios under which information that is not generated by an applicant could be useful to support a submission for drug approval under Section 505(b)(2) of the FDC Act. In developing a strategy, one must consider the quickest route to approval, the best labeling and the broadest use supported by the data. Depending on the products to be submitted for approval (changes to an approved drug, a marketed unapproved drug, or a new chemical entity with previously published information), the scope and the extent of the available information will have an impact on the bridging (nonclinical, clinical) studies to be performed and submitted.

In this conference, the speaker describes the drugs that can and cannot be submitted under Section 505(b)(2), strategies for different products, the role of patents and marketing exclusivity, and types of bridging studies. He also shares insights into search strategies to obtain and select appropriate published literature references, preparation of summaries, use of previous agency findings of safety and effectiveness, and the potential pitfalls in using published literature findings and agency findings.

505(b)(2) Submissions: Eligibility, Strategies & Preparation is being presented by Dr. Howard Hubbell, President, of Hubbell Consulting, LLC and airs on Tuesday, October 27, 2009. For more details, or to register please visit our site at www.fxconferences.com

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway

The new FDA requirements cover both the format (SPL Release 4 files) and the submission modality (via the FDA Electronic Submissions Gateway – ESG) for electronic drug establishment registrations and drug listings, imposing a double electronic challenge upon all firms who must register and list. As of June 1, 2009, paper forms FDA 2656 and FDA 2657 are no longer acceptable. Many firms have been surprised by the challenge and complexity of electronic drug establishment registrations and drug listings. Headaches and frustrations with the tools, the process and the content are increasing as the end of 2009 approaches.

To meet an end-of-year deadline, firms must have a solution for ESG connectivity in place, as well as a means to prepare and validate their SPL R4 files. Most importantly, they must have a solid grasp of the content necessary to produce compliant drug registrations and listings. In this session, the speaker provides practical advice regarding SPL-R4 file content, submissions and validation.

Drug Establishment Registrations, Drug Listings and the FDA Electronic Submissions Gateway is being presented by Dr. Greg Onyszchuk, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates, Inc. and airs on Thursday, October 22, 2009. For more information about this audio conference, or to register please visit our site at www.fxconferences.com

Managing the Shift to Electronic Submissions

The electronic common technical document (eCTD) presents many challenges to a Sponsor organization, but may also yield significant benefits through increased efficiencies and improved reviews by regulatory agencies. Sponsor organizations that have decided to adopt the eCTD now have the challenging task of managing and implementing the paradigm shift from paper to electronic regulatory submissions.

The first of many challenges is to evaluate and modify existing document preparation processes to accommodate differences between paper and eCTD. Once these changes have been identified, the next step is to convince upper management the changes are necessary to move the organization forward to preparing electronic submissions. Another challenge is working with vendors to receive electronically-compliant documents. The eCTD requires sponsor organizations to rethink their business and those with whom they do business.

Managing the Shift to Electronic Submissions was presented by Gina Ross, Director, Managing Consultant, Regulatory Publishing Services, with Beckloff Associates a Cardinal Health and aired on 2008-04-17. For more information, or to download this audio conference please visit our site at www.fxconferences.com

Using SharePoint in an FDA-Regulated Environment

Pharmaceutical and biotech companies have been facing increasing demands to improve their organizational effectiveness through information sharing and collaboration. At the same time, there is an important need for a controlled document management system that is compliant with FDA regulations. In this conference, our speakers look at the steps necessary to design and implement Microsoft SharePoint within the confines of a regulated environment. The presentation discusses various solutions, with a special focus on regulatory needs at various stages of the drug development lifecyle.

Speakers John Postle and Cary Cyr explain how to achieve ongoing compliance through the use of SharePoint as a validated application in a qualified environment. They also present a real-life case study from Tufts Medical Center, which illustrates how research laboratories are using SharePoint for collaboration.

Using SharePoint in an FDA-Regulated Environment is being presented by John Postle & Cary Cyr, Vice President, Life Science Enterprise & Senior SharePoint Specialist, with Court Square Group and airs on Thursday, October 22, 2009. For more details or to register, please visit our site at www.fxconferences.com

Clinical Data Requirements under the New MDD & AIMDD

The Medical Device Directive (MDD 93/42/EEC) and the Active Implantable Medical Device Directive (AIMDD 90/385/EEC) have been significantly changed by the European Amended Device Directive (2007/47/EC), and many of these changes are expected to become active in March 2010. Clinical evaluations must follow a well-defined and methodologically sound procedure. In this audio conference, the speaker describes these expectations for clinical evaluations and provides suggested templates for clinical evaluation reports (literature reviews and clinical studies).

This session provides valuable information to Class I and Class IIa medical device manufacturers, who may now be expected to add clinical evaluations to their current technical documentation in the EU. It also provides important insights for regulatory, clinical and quality departments within device manufacturing companies, as well as to CROs and consultants who are assisting these companies with their 2010 compliance preparations.

Clinical Data Requirements under the New MDD & AIMDD is being presented by Dr. Joy Frestedt, President/CEO, of Frestedt Incorporated and airs on Wednesday, October 21, 2009. For more details, or to register please visit our site at www.fxconferences.com

Creating New Domains in CDASH

This is the third in a series of three audio conferences focusing on the CDASH (Clinical Data Acquisition Standards Harmonization) standard. The first two discussed the 16 existing CDASH core data domains and how to map CRFs to those domains. Most studies will also include data that are not part of CDASH, and making these data CDASH consistent will greatly increase the efficiency of data capture and submission. This session examines how to develop CDASH-consistent CRFs and data structures for these non-core domains.

Using the principles and assumptions underlying CDASH, the speaker walks through how to identify the correct CDASH data model, defines the CRF questions and associated data structures, addresses controlled terminology and determines compatibility with SDTM, the electronic regulatory submission data standards. The appropriate information sources are discussed and the results are captured in a useful online tool. This audio conference assumes the attendee has some familiarity with basic CDASH terms and concepts, and/or has attended previous sessions in this series.

Creating New Domains in CDASH is being presented by Kit Howard, Principal and Owner, with Kestrel Consultants and airs on Tuesday, October 20, 2009. For more details or to register, please visit our site at www.fxconferences.com

Outsourced Data Management: How to Align Performance Expectations

When it comes to clinical development outsourcing, it is not uncommon to see that data management has not been included in the process until it is well underway or nearly complete. Unfortunately, this tactical approach to data management outsourcing opens the door for performance expectations to diverge once the trial is underway, as initial expectations were never made transparent and fully aligned.

This session explores the challenges and strategies involved in successful data management outsourcing between sponsor companies and CROs. The speaker shares his insights and offers actionable, pragmatic approaches to consider, and reviews case studies which measure the impact of these approaches on a sponsor’s business success.

Outsourced Data Management: How to Align Performance Expectations is being presented by Mark Anderson, Senior Director, Clinical Data Management, with Covance and airs on Wednesday, October 28, 2009. For more details or to register, please visit our site at 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 includes 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 was presented by Daryl Wisdahl, Director, with Wisdahl Consulting Group and aired on 2008-11-20. For more details, or to download this conference please visit our site at www.fxconferences.com