The Case for Value-Based Content Management

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

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

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

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

Risk Mitigation and Prevention in Real-Life Trials

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

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

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

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

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

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

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

State of Readiness? XML in the Life Sciences

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

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

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

Navigating the European Human Tissue Maze

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

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

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

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

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

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

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

Global Unifying Trends in Device Regulation

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

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

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

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

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

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

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

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

Improving Clinical Development with Six Sigma

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

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

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

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

New EU Rules for Tissue Engineered Products

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

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

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

Biomarker Data Interpretation and Challenges of Biological Variation

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

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

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

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

e-Consent: An Idea Whose Time has Come

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

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

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

Leveraging the Benefits of eMDR (Electronic Medical Device Reporting)

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

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

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

International Sponsor-CRO Relationships: A Legal View

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

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

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

Recruiting Research Participants Using Web-Based Software

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

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

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

Pharma 2010: The Threshold of Innovation

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

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

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

Moving Target: Animal Tissue Regulations Update

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

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

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

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