What's Past is Prologue: A Regulatory Perspective on Contemporaneous Diagnostic Co-Development

June 27, 2012 - PRLog -- Moderator: Janet Jenkins-Showalker, Director, Regulatory Affairs, FDA Liason,  
F. HOFFMANN-LA ROCHE

A Panel of Experts will discuss:
- Lessons learned from contemporaneous diagnostic co-development successes
- The current and future regulatory environment
- How the most recent "poster-child" success stories, along with the regulatory environment  and interested stakeholders, will shape the future of personalized medicine

Panelists:
Erling Thor Donnelly, Ph.D., R.A.C., Director, Worldwide Regulatory Strategy, PFIZER, INC.  (Regulatory Lead for Xalkori)

Pamela L. Swatkowski, Director, Regulatory Affairs, ABBOTT MOLECULAR, INC.
(Regulatory Lead for ALK FISH Test)

Linda Burdette, Ph.D., Director, Drug Regulatory Affairs, F. HOFFMANN-LA ROCHE, INC.
(Regulatory Lead for Zelboraf)

Lesley Farrington, Senior Manager, Regulatory Affairs, ROCHE MOLECULAR SYSTEMS
(Regulatory Lead for cobas BRAF Mutation Test) Co-Located Conference

View the entire conference agenda for the Regulatory Compliance in Drug-Diagnostic Co-Development conference at http://www.NextGenerationDx.com/Regulatory-Compliance-Dia....

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