Part 99 The Aftermath: Use of Off-Label Information?

Why should you take this eConference?
Is your marketing department frequently asking questions about the use of medical article reprints? Have you heard about recent court cases that may impact use of off label information, but are unsure how they may impact your company’s policies? This course is designed to help participants formulate sound regulatory strategy and procedures for use of off label information covered by Part 99.

You will learn:
You will learn not, only the content of Part 99, but the practical implications of what it means for industry; how it has been and may continue to be challenged; and what is FDA’s current enforcement approach.

Who should attend:
Regulatory and clinical professionals with responsibility for determining whether and how off label information can be used, as well as marketing and sales personnel who may be involved with this function.

You will receive:
- Slides
- An expert speaker
- A chance for QnA
- CEUs & Certificate

Presenter:
Clinical Device Group is proud to present Ms. Janice M. Hogan, Esq. and Partner of  Hogan & Hartson, LLP. Janice is a biomedical engineer and focuses on regulatory counseling related to high technology medical products. Prior to becoming an attorney, she held positions in marketing/ marketing research for a major pharmaceutical manufacturer. She has authored articles regarding orphan drug regulation and medical device products liability. She is currently authoring articles regarding the use of finite element analysis and other engineering modeling methods in FDA submissions, as well as the interface between FDA regulatory and reimbursement considerations in the design of medical product clinical trials. She has authored a chapter of a recent textbook, Promotion of Biomedical Products (FDLI 2006) and is authoring a chapter of a forthcoming textbook on the regulation of orthopedic implants. Janice has served as an adjunct professor at the University of the Sciences in Philadelphia and as a guest lecturer at Drexel University. She is also a frequent lecturer at FDA regulatory law symposia and conferences on topics related to premarket approval of medical products, combination products regulation, and product development. Janice can be reached at http://www.hhlaw.com/jmhogan/

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.