Keith M. Korenchuk Covington & Burling LLP, Washington, DC

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Presentation transcript:

Keith M. Korenchuk Covington & Burling LLP, Washington, DC Ninth Annual Pharmaceutical Regulatory and Compliance Congress Washington DC October 28, 2008 Track VI Interactive Case Studies Sue Egan Vice President Compliance, International Sales and Marketing Organisation, AstraZeneca PLC, London, UK Michael Shaw Global Head, Ethics and Compliance, Novartis Oncology, Florham Park, NJ Doreen F. Shulman Vice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb Keith M. Korenchuk Covington & Burling LLP, Washington, DC

Morning Track VI: Interactive International Case Studies Topics 1. Distribution Channel Challenges; 2. Third Party Oversight (Including Use of HCPs as Third Parties, and Anti-bribery and Anti-corruption Considerations); 3. Organization of International Congresses and Conferences for HCP Attendance; and 4. Management of Allegations and Investigations

Interactive International Case Studies: Key Questions What action would you take? Other discussion Items: What are the compliance program elements implicated by this scenario? What would you look for in evaluating the compliance framework?

Afternoon Track V: Interactive Domestic Case Studies Topics 1. Speaker Management Issues 2. In-Office Interactions 3. Conflicts of Interest with Customers 4. Firewall Issues Related to Marketing/Medical Vendors 5. PhRMA Code Issues Pre- and Post- implementation. and Investigations

Interactive Domestic Case Studies: Key Questions What action would you take? Other discussion Items: What are the compliance program elements implicated by this scenario? What would you look for in evaluating the compliance framework?