Setting Up Registries: Reasons and Roadmaps

Flexible way to get product 'in the door':
Registry studies provide a flexible way to bypass purchasing and introduce new products to physicians, collect post-market reimbursement data, demonstrate product effectiveness, explore new hypotheses, and persuade the doc that your device should be added to the hospital pharmacopoeia. So how do you set it up?

The e Conference:
Dr. Gail Radcliffe will combine examples and industry feedback to give a presentation that addresses how to use registries to bring products to market and introduce treatments to physicians. She will address why you might want to open a registry, study design, IRB issues, consent, how much to pay, use for off label submission to FDA, existing data sources, and other common concerns.

You will receive:
1. PowerPoint slides.
2. A well-researched presentation.
3. Valuable case studies.
4. An expert speaker.
5. Chance to listen to other's QnA.
6. CEUs and certificate of attendance.

The presenter:
Gail E Radcliffe, PhD assists IVD device, medical device, and biotech companies with technical, marketing, regulatory, and business development issues. She brings a unique viewpoint to the overall process of product development. Dr. Radcliffe helps emerging companies assess platform technologies to meet customer needs, conducts technical due diligence, and provides regulatory strategy assistance. She holds several patents and has worked with clients to obtain funding through angel investments, venture capital and Small Business Innovation Research (SBIR) grants. You can reach her at gradcliffe@charter.net. 

Audience suitability:
[x] Regulatory professionals.
[x] Clinical research professionals.
[x] People who work in clinical device trials.
[x] Marketing professionals.
[x] Monitors.
[x] Statistical professionals.
[x] Managers who sign off on clinical trials.
[x] Executives who are planning their companies futures.

The purchase is $420 for OnDemand access and $470 for the CD. Event materials are available by download for OnDemand or are 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.