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Monday, June 8
2:00-5:00pm
Recommended Pre-Conference Short Course
(SC5) COLLABORATING TO ACCELERATE THE
ADOPTION OF NOVEL TECHNOLOGIES IN
THE PRECLINICAL R&D PROCESS
RISK MANAGEMENT & STRATEGY
Best Practices in Developing Risk Management Programs – A Life Cycle
Approach
Working to Improve Prioritization and Decision Making in the Area of
Drug Safety
Steps to Identify Earlier and Better Assessment of Potential Risk of
Compound in Development
Ernie Bush, Ph.D., Vice President, Collaborative Projects,
Drug Safety Executive Council
Anthony Lassiter, Senior Medical Director, Product Safety and
Pharmacovigilance, Astellas
Jack Reynolds, D.V.M., Chairman, Advisory Board, Drug Safety
Executive Council
Axel Olsen, Ph.D., Executive Director, Pharmacovigilance/Risk
Management, Quintiles
PRECLINICAL SAFETY STRATEGY &
RISK MITIGATION
Designing Preclinical Studies to Best Elucidate Safety Profiles
and Risks
Are There Ways for The Industry to Work Together through the Sharing of
Toxicity Data?
Early Risk Identification using Novel Multidimensional Data Mining
Technology
Mohammad Afshar, M.D., Chief Executive Officer, Ariana Pharma
Berengere Dumotier, Ph.D., Preclinical CardioSafety Expert, Preclinical
Safety, Novartis
Mitchell Friedman, Ph.D., Director, Toxicology, Nonclinical Safety &
Efficacy, Takeda
George McCormick, Ph.D., Vice President, Drug Safety & Disposition,
Cephalon
Yvonne Will, Ph.D., Group Leader, Exploratory Safety
Differentiation-Cell Based Assays, Pfizer
A HOLISTIC APPROACH TO DRUG SAFETY AND CROSS-FUNCTIONAL TEAMS
Developing a Cross Functional Team to Produce the Right Risk Management
Plan
How Can We Improve Cross-Discipline Collaboration in Risk Management
Planning?
Minimizing Legal Risks When Responding to an
FDA REMS Request
Julio Caso, M.D., Vice President, Global Medical Affairs, Sepracor
Robert Di Giovanni, M.D., Brand Safety Leader, CVM/CD&MA, Novartis
Joanna F. Haas, M.D., Vice President, Pharmacovigilance, Genzyme
Judith Marquis, Ph.D., Group Vice President, Pharmacology and
Preclinical Development, Genzyme
| Drug
Safety Executive Council |
The Drug Safety Executive Council (DSEC) is a peer-to-peer membership of drug safety leaders with the common objective of advancing the development of better and safer medicines worldwide. Membership in DSEC is limited to leaders representing companies who develop small and large molecule pharmaceuticals only. |
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