Session Information
2007 BIO International Convention
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RiskMAP Plans: Enhance Patient Safety While Mitigating Product Liability Risk
Track
:
Intellectual Property/Legal
Program Code:
INT010
Date:
Monday, May 7, 2007
Time:
9:15 AM to 10:45 AM
Location:
257 AB
CHAIR
:
Frank Goudsmit, Vice President, Chubb Group of Insurance Companies
SPEAKER
(S):
Edgar Adams, ScD, Exective Director, Epidemiology, Late Stage Development Services, Covance Inc., NJ, United States James Walters, Managing Director, Life Sciences National Practice Leader, Aon Risk Services, Inc.
Description
The FDA had embraced RiskMAP (Risk Minimization and Action Plans) as a framework within which companies can assess and mitigate risks. This panel session will address considerations in designing a RiskMAP plan, offer practical advice on how to make such plans powerful and effective, and discuss how implementing such plans affects litigation vulnerability.
Objectives:
Educate attendees about the process of developing RiskMAP plans.
Share practical advice from companies that have been through the process (Biogen Idec for Tysabri).
Provide regulatory and legal advice on the considerations surrounding such plans.
Objectives:
Streaming Audio with
PowerPoint Slides
PowerPoint Slides
(Code: INT010)
This session is a part of: