The Successful IDE

We know that 99% of IDEs are reviewed within 30 'FDA review' days, but how many are approved? Ultimately, less than 60% in 2007 and the review time was often 90 days or more. And was the IDE approved or withdrawn? The most common questions had to do with study design and statistical design, followed by issues with the consent form.

Benchmark your practices with those of an experienced regulatory professional and stay ahead of the issues before they become questions from FDA.

You will receive:
1. Help with IDE issues.
2. PowerPoint slides.
3. An expert speaker.
4. Case studies and examples.
5. Chance to listen to other's QnA.
6. CEUs and certification of attendance

The presenter:
Janice Hogan is a partner in the offices of Hogan and Hartson LLP and a member of the firm’s Food, Drug, Devices, and Agriculture Group. Her practice focuses on the representation of medical device [and other] manufacturers before FDA. She is a biomedical engineer and specializes in regulatory counseling related to high technology medical products. You can reach Ms. Hogan at http://www.hhlaw.com/jmhogan/

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 $422 for OnDemand access and $472 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.