Health China
Inaugural Risk Management and Drug Safety Strategies for Better Decision Making
Loews Philadelphia Hotel
1200 Market Street
Philadelphia, PA
Inaugural Risk Management and Drug Safety Strategies for Better Decision Making
Cambridge Healthtech Institute

Schedule of Presentations:

Wednesday, June 10, 2009
07:20:00 Check-In
13:55:00 Chairperson’s Remarks Jack Reynolds
14:00:00 An Industry Survey of Benefi t-Risk Management Best Practices Ernie Bush
14:30:00 Best Practices in Developing Risk Management Programs: A Life Cycle Approach Axel Olsen
15:00:00 How Can We Ensure Patient Safety? David Brewster
15:30:00 Sponsored Presentation (Opportunity Available)
15:45:00 Networking Refreshment Break in the Exhibit Hall
16:30:00 Risk Assessment, Evaluation and Management: A Safety Governance Structure Anthony Lassiter
17:00:00 Holistic Evaluation of Risk: Evaluation of ADME/PK, Pharmacology and Toxicology Data to Adequately Assess NMEs Mitchell Friedman
17:05:00 Chairperson’s Remarks
17:10:00 Announcements
17:30:00 End of Day
17:45:00 Discussion
18:25:00 Preparation for next day
Thursday, June 11, 2009
08:00:00 Morning Coffee
08:00:00 Registration Open
08:30:00 Chairperson’s Remarks Ernie Bush
08:40:00 Risk Mitigation Strategy for Cardiotox: A Case Study in Oncology Bérengère Dumotier
09:10:00 Designing Preclinical Studies to Best Elucidate Safety Profi les and Risks George C. McCormick
09:40:00 Preclinical Strategies in the Development of Biopharmaceuticals: Challenges and Opportunities Michael W. Leach
10:10:00 Networking Coffee Break in the Exhibit Hall
10:55:00 Better than Opinion: Using Low-Cost Toxicity Screening Methods To Set Occupational Exposure Limits For APIs And Intermediates. Mark Maier
11:25:00 Steps to Identify Earlier and Better Assessment of Potential Risk of Compound in Development Lewis Kinter
11:55:00 Luncheon Presentation
12:55:00 Session Break
13:25:00 Chairperson’s Remarks Sasha Latypova
13:30:00 Drug Safety Strategies: New Approaches to Old Problems Jack A. Reynolds,
14:00:00 FEATURED TALK: How Can We Create Awareness, Reduce Barriers and Improve Cross-Discipline or Cross- Department Collaboration in Risk Management Planning and Pharmacovigilance? Joanna F Haas, Judith K Marquis
15:00:00 Ice Cream Refreshment Break in the Exhibit Hall (Last Chance for Viewing)
15:40:00 Strengthening Relationships: How Safety Risk Management Changes The Role Of Drug Safety Janet M. Price
16:10:00 PANEL: Developing A Cross Functional Team to Produce the Right Risk Management Plan Joanna F Haas, Janet M. Price, Judith K Marquis
17:10:00 Close of Risk Management and Drug Safety Conference
17:15:00 Discussion
17:55:00 Announcements
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