3D Tissue Models
Managing Legal Risks and Avoiding Conflicts of Interest in Medical Affairs
The Union League
140 South Broad Street
Philadelphia, PA

Schedule of Presentations:

Monday, December 1, 2008
08:00:00 Registration and Continental Breakfast for the Boot Camp
08:30:00 Medical Affairs 101 - A Primer on the In’s and Out’s of Establishing, Maintaining and Monitoring Your Medical Affairs Department Gary C Messplay, Elizabeth V Jobes, Diane B Nelson
11:30:00 Boot Camp Concludes And Lunch
12:30:00 Main Conference : Registration Begins
13:00:00 Co-Chairs’ Opening Remarks Gary C Messplay, Beverly H Lorell
13:15:00 Update on Current Industry Initiatives, Regulatory Guidance and Enforcement Trends Affecting Medical Affairs Deborah Livornese, Brian A. Dahl
14:30:00 Networking Break
15:00:00 Drawing the Line with Off-Label Communications: Distinguishing Unsolicited Requests and Scientific Exchange from Proactive, Promotional Discussion Cynthia Phillips, Alan G Minsk
16:00:00 Revamping Policies for CME, Education Grants, and Physician-Industry Relationships to Achieve Increased Transparency in Operations Kristin Rand, Maureen Scharff Doyle, Frank Skopowski
17:00:00 Physician and KOL Activities Rachel Abramovitz
18:00:00 Conference Adjourns to Day Two
Tuesday, December 2, 2008
08:00:00 Continental Breakfast
08:30:00 Co-Chairs’ Remarks
08:45:00 Tackling New Issues Presented by the Evolving Regulatory Landscape Governing Clinical Trials and Registries under FDAAA Beverly H Lorell, Natasha Leskovsek
10:00:00 Overcoming Unique Challenges of Conducting Clinical Trials in International Waters: Maintaining Privacy, Safeguarding Data, and Complying with Varying Regulatory Nuances Grail Walsh Sipes, Elizabeth M Zechenter
11:15:00 Networking Break
11:45:00 Advanced Strategies for Implementing Defined Metrics and Achieving Adherence to Compliance in Your Department Howard L Dorfman, Marc J Scheineson
12:45:00 Main Conference Concludes and Registration Begins for the Master Class
14:00:00 Balancing the Interface Between Medical Affairs and Sales and Marketing - Specifying Appropriate Interdepartmental Practices and Procedures to Address Publications, Promotions, Authorship, Phase IV Studies, and the Use of Consultants Deborah Livornese, Maria D Buckley, Beverly H Lorell
17:00:00 Master Class Concludes
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