BIO and The RPM Report Present an Interactive Webinar Series
Speaker BIOs |
BIO Members: Download and listen to the recording of the first webinar |
Your interactions with the FDA are important to your company, and in today's regulatory environment it is imperative that sponsors have a firm understanding of FDA's expectations around drug and biologic risk management.
This webinar series will focus on specific segments of the FDA approval process in order to provide more in-depth discussions with FDA regulatory experts. The third webinar in this series will focus on Risk Evaluation and Mitigation Strategy (REMS).
The goal of this webinar is to provide background and strategic insight for emerging or established companies regarding the REMS process as a key element of FDA approval and global risk management. Specifically, panelists will discuss policy and operational considerations regarding development, FDA review, administration, and evaluation of REMS programs.
If you are an emerging biotech company executive, regulatory or clinical staff –
Participate in BIO's educational webinar program, Understanding REMS in the FDA Approval Process. As a biotech company, you will gain:
- Tips for improving your interactions with FDA when deciding if a REMS is necessary, and if so, what REMS elements and risk mitigation tools are appropriate for your product
- Understanding of FDA's expectations for REMS approval in both the pre- and post-market settings
- Analysis of FDA's new draft guidance on "Format and Content of Proposed Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, and Proposed Modifications"
- Insights into successful REMS strategies from FDA and industry regulatory experts
- Better understanding of how to successfully assess and evaluate whether a REMS program is achieving its stated goals
- Best and worst practices in addressing FDA risk management concerns in a timely manner
Date: Tuesday, December 8, 2009
Time: 1:00 PM - 2:30 PM (EST)
Moderator: Ramsey Baghdadi, Editor-in-Chief, The RPM Report
Speakers:
Member of FDA - To Be Determined
Florence Houn, MD, MPH, Vice President, Regulatory Policy and Strategy, Celgene
Nancy Lurker, CEO, PDI,
Andrea Masciale, Senior Director for Global Regulatory Affairs Strategic Policy and Support, Johnson and Johnson
Reservations are limited. Free for BIO Members, $125 for non-BIO members.
The RPM Report provides unique insight and analysis for biopharmaceutical executives on FDA, CMS and public sector issues. www.therpmreport.com.
Ramsey is a founding member and editor of The RPM Report, a monthly magazine focused on the development of commercial strategies based on regulatory and policy realities. The RPM Report focuses its coverage on FDA, CMS and Congress as they impact biotech and pharmaceutical companies. Prior to The RPM Report, Ramsey was a contributing editor to The Pink Sheet and also covered the medical device and OTC drug industries.
