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Ninth Annual Pharmaceutical Regulatory and Compliance Congress Washington DC October 28, 2008 Track VI Interactive Case

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

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Ninth Annual Pharmaceutical Regulatory and Compliance Congress Washington DC October 28, 2008 Track VI Interactive Case

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  1. Ninth Annual Pharmaceutical Regulatory and Compliance CongressWashington DCOctober 28, 2008Track VIInteractive Case Studies Sue EganVice President Compliance, International Sales and Marketing Organisation, AstraZeneca PLC, London, UK Michael ShawGlobal Head, Ethics and Compliance, Novartis Oncology, Florham Park, NJ Doreen F. ShulmanVice President, Chief Compliance and Ethics Officer, Bristol-Myers Squibb Keith M. KorenchukCovington & Burling LLP, Washington, DC

  2. 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

  3. 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?

  4. 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

  5. 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?

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