Wednesday, April 21, 2010
Post-Conference Workshop
9:00 a.m. – 12:00 p.m.
(registration begins at 8:15 a.m.)
Manufacturers’ Working Session – Preparing for and Implementing a REMS
Debra S. Dunne
Partner
STRADLEY RONON STEVENS & YOUNG, LLP (Philadelphia, PA)
Michelle T. Dillione
Assistant General Counsel, US Sales & Marketing
AstraZeneca (Wilmington, DE)
Developing and implementing a successful REMS can be a daunting task. Because there are so many different components involved, manufacturers need to know what to expect and have a strategy in place before they are faced with a product that requires a REMS. While each product is unique, there are universal issues that each company faces and general strategies that can be applied to solve your company’s unique challenges.
This workshop will be a working session where attendees will work through the challenges and issues a company faces when developing a REMS. Through the presentation of a hypothetical involving a pre-approval product that raises safety/risk issues for the company and presenting mock FDA interactions, speakers will address the following issues:
- Determining whether a product will need a REMS
- reviewing and evaluating clinical trial data
- Presenting safety information to the FDA
- Navigating the REMS negotiation process
- Drafting a REMS
- Executing a communications plan
- working with third parties that will be communicating risks and dissemination medication guides
- what role should sales representatives and MSLs play?
Conference Details
