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