Why Should You Register Your Clinical Trial

Why register? Because it is required by law!
US Public Law 110-85 (Food and Drug Administration Amendments Act of 2007) mandates the registration of certain device clinical trials. Will you be ready for the requirements effective on December 26, 2007?

Why register? So you can publish!
There are unpredictable changes happening in the publication world. The most recent example -- you may not be allowed to publish your trial results if you don't register your study before hand. Who says so? The International Committee of Medical Journal Editors says so. Where do you register? We'll tell you.

Objective:
The world doesn’t stop with submitting the clinical study report to FDA. To have marketing value, to become an accepted part of medical practice, to give your sales force a reason to walk through the customer's door, your message needs to get to the clinical community through peer-reviewed literature. This conference will tell you how to get there.

You will learn:
- How, when, and where to register your clinical trial
   - Overview of ClinicalTrials.gov.
   - How to apply for an organizational account.
   - How to register a clinical trial.
- New Requirements of US Public Law 110-85.
-Which trials should be registered?
- Why you should write the manuscript before you start the clinical trial?
- What you should tell the editor and when.
- What about ‘negative trials’?
- Maybe I can't write, can I hire it to be done?
- What's wrong with ‘ghost writers'?

Who should attend:
- Device Manufacturers
- Sponsors
- Regulators
- CROs
- Clinical and marketing professionals
- Project managers

Presenters:
The eConference will be co-presented by Dr. Nancy J Stark and Ms. Rebecca J. Williams, Pharm.D.

Dr. Stark was selected as one of 100 notable people in the medical device industry by Canon Communications in 2004. You can learn more about her at http://www.nancystark.com.

Rebecca Williams, Pharm.D., is Assistant Director, ClinicalTrials.gov at the Lister Hill National Center for Biomedical Communications in the National Library of Medicine. In this capacity, she is involved with policy issues affecting registration of clinical trials, outreach activities, and efforts related to researching and implementing a clinical trial results database. Her prior experience includes reviewer and supervisory roles at the U.S. Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research (CDER), Division of Drug Marketing, Advertising, and Communications (DDMAC). Most recently, she worked for SAIC as a consultant and provided expert advice to pharmaceutical industry on compliance with FDA regulations for promotional and scientific activities. She received her Pharm.D. from the University of Wisconsin–Madison. You can contact Ms. Williams at williamsre@mail.nih.gov.

The purchase is $402 for the CD. Event materials are available on the CD itself. Each attendee is eligible for 0.15 CEUs upon completing the course feedback via the link provided with the event materials. Click here to purchase.