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

The Revised MDD: Practical Implications for Devices

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

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

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

Changing Your Approach for Success in Post-Market Research

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

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

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