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PRE-CONFERENCE SYMPOSIA Thursday, May 28, 2009 |
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7:00 a.m. |
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Congress Registration |
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8:00 a.m. |
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PRECONFERENCE I |
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INTERNATIONAL COMPLIANCE PROGRAM BASICS Sue Egan Vice President Compliance, AstraZeneca PLC, London, UK Dominique Laymand, Esq. Senior Director Compliance & Ethics EMEA (Europe, Middle East, Turkey, Russia and Africa), Bristol-Myers Squibb, Paris, France Presentation Material (Acrobat) |
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9:45 a.m. |
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Preconference I Adjournment |
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8:00 a.m. |
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PRECONFERENCE II |
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FCPA, ANTIBRIBERY AND ANTICORRUPTION Paul V. Gerlach, Esq. Partner, Sidley Austin LLP, Former Associate Director, Division of Enforcement, US Securities & Exchange Commission, Washington, DC Presentation Material (Acrobat) SanDee Priser Partner, Fraud Investigation and Dispute Services, Ernst & Young AG, Germany Presentation Material (Acrobat) Philipp Rau Associate, Clifford Chance, Frankfurt, Germany Presentation Material (Acrobat) |
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9:45 a.m. |
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Preconference II Adjournment |
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8:00 a.m. |
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PRECONFERENCE III |
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COMPLIANCE RISK MANAGEMENT Thomas E. Costa Vice President, U.S. Pharmaceuticals Compliance & Ethics, Bristol-Myers Squibb, Princeton, NJ, USA Jonathon L. Kellerman Partner, Pharmaceutical and Life Sciences Practice, PricewaterhouseCoopers LLP, Philadelphia, PA USA Presentation Material (Acrobat) |
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9:45 a.m. |
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Preconference III Adjournment |
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International Pharma Congress Day One Thursday, May 28, 2009 |
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10:00 a.m. |
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Welcome and Overview of Day I - Morning Plenary Session Sue Egan Vice President Compliance, AstraZeneca PLC, London, UK (Co chair) |
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10:15 a.m. |
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Opening Keynote Address Nicola Braggio Marketing Company President, Astrazeneca Italy, Milan, Italy No Presentation Provided |
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10:45 a.m. |
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Major Trends and Challenges of the Pharmaceutical Industry, in the EU and the Emerging Markets Richard Bergstrom, MScPharm Managing Director, Swedish Association of the Pharmaceutical Industry, Chairman, IFPMA Code Compliance Network, Chairman, EFPIA Code Steering Committee, Stockholm, Sweden No Presentation Provided |
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11:15 a.m. |
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Reputation is Everything - Pharma Transparency and Sustainability Challenges Ted Acosta, Esq. Principal, Ernst & Young LLP, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY, USA and Paris, France Frederique Santerre Director, IFPMA, Geneva, Switzerland Heather Simmonds Director, Prescription Medicines Code of Practice Authority, London, UK Willy Vanbuggenhout, JD, MBA Chief Compliance Officer, Johnson & Johnson, Brussels, Belgium Dave O'Shaunessy Vice President and Compliance Officer, Emerging Markets and Asia Pacific, GlaxoSmithKline, Brentford, Middlesex, UK (Moderator) No Presentation Provided |
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12:15 p.m. |
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Networking Luncheon |
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1:30 p.m. |
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Concurrent Sessions I |
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1.01 |
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Track I: Regulatory-The Burden of Compliance following the European Commission's Sector Study: Where Do We Go From Here? Tim Frazer, Esq. Partner, Arnold & Porter (UK) LLP, Former Professor and Dean of Law, Newcastle University, London, UK Presentation Material (Acrobat) |
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1.02 |
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Track II: Interactive Case Studies in Navigating the Issues and Pitfalls of Sponsoring International Events, including Practical Considerations Relating to Local Country Approvals, Educational Grants, Involvement in Content, Sponsorship of Invitees, etc. Sue Egan Vice President Compliance, AstraZeneca PLC, London, UK Michael Shaw Global Head, Ethics & Compliance, Novartis Oncology, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, Florham Park, NJ USA Presentation Material (Acrobat) Elisabethann Wright, Esq. Partner, Hogan & Hartson, Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium |
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1.03 |
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Industry and Corporate Standards-Transparency, Including:
Managing Director, Swedish Association of the Pharmaceutical Industry, Chairman, IFPMA Code Compliance Network, Chairman, EFPIA Code Steering Committee, Stockholm, Sweden Presentation Material (Acrobat) Jennifer Colapietro Director, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLC, Florham Park, NJ, USA Presentation Material (Acrobat) |
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2:30 p.m. |
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Transition Break |
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2:45 p.m. |
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Concurrent Sessions II |
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2.01 |
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Track I: Regulatory-The New EU Pharma Package: Impact of Proposed Rules on Information to Patients Maurits J.F. Lugard, MA, JD, LLM Partner, Sidley Austin LLP, Former Member of the European Commission's Legal Service, Brussels, Belgium Paul B. Woods, BPharm, MA, MRPharmS Global Compliance Policy Director, AstraZeneca, Co chair, EFPIA Information to Patients Task Force, Macclesfield, Cheshire, UK Elisabethann Wright, Esq. Partner, Hogan & Hartson, Former Senior Legal Officer and Hearing Officer, EFTA Surveillance Authority, Brussels, Belgium Presentation Material (Acrobat) |
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2.02 |
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Track II: Fighting Corruption Ted Acosta, Esq. Principal, Ernst & Young LLP, Former Senior Counsel, Office of Inspector General, US Department of Health and Human Services, New York, NY, USA and Paris, France Guitelle Baghdadi-Sabeti, PharmD, MPH Technical Officer, Medicines, Policies and Standards Department, World Health Organization, Geneva Stephen Mohr, Esq. Global Compliance Officer, AstraZeneca, London, UK Roeland van Aelst Executive Director International, WW Office Health Care Compliance & Privacy, (EMEA, Canada, Lat-Am, Asia-Pac), Johnson & Johnson, Brussels, Belgium No Presentation Provided |
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2.03 |
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Track III: Industry and Corporate Standards-Consolidation, Harmonization and Practical Implementation of Codes Richard Bergstrom, MScPharm Managing Director, Swedish Association of the Pharmaceutical Industry, Chairman, IFPMA Code Compliance Network, Chairman, EFPIA Code Steering Committee, Stockholm, Sweden Presentation Material (Acrobat) Thomas E. Costa Vice President, U.S. Pharmaceuticals Compliance & Ethics, Bristol-Myers Squibb, Princeton, NJ, USA Presentation Material (Acrobat) Marie-Claire Pickaert Deputy Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Brussels, Belgium Presentation Material (Acrobat) Jose Zamarriego Director, Code of Practice Surveillance Unit, Farmaindustria, Madrid, Spain Presentation Material (Acrobat) Dominique Laymand, Esq. Senior Director Compliance & Ethics EMEA, (Europe, Middle East, Turkey, Russia and Africa), Bristol-Myers Squibb, Paris, France (Moderator) Presentation Material (Acrobat) |
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3:45 p.m. |
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Transition Break |
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4:00 p.m. |
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Concurrent Sessions III |
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3.01 |
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Track I: Regulatory-Fighting Counterfeits and Diversion: Approaches to Fighting Counterfeits in EU Pharma Package, US and WHO Proposals Pierre E. Dupourque Regional Compliance Director, Corporate Compliance, International Investigations and Programs, Pfizer, Inc., Berlin, Germany Brett Rowland, Esq. Associate, Sidley Austin LLP, London, UK Presentation Material (Acrobat) |
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3.02 |
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Track II: Transparency-Working with Patient Groups Richard Bergstrom, MScPharm Managing Director, Swedish Association of the Pharmaceutical Industry, Chairman, IFPMA Code Compliance Network, Chairman, EFPIA Code Steering Committee, Stockholm, Sweden Presentation Material (Acrobat) Allison Weber Shuren, MSN, JD Partner, FDA and Healthcare Practice Group, Arnold & Porter LLP, Washington, DC Presentation Material (Acrobat) Paul B. Woods, BPharm, MA, MRPharmS Global Compliance Policy Director, AstraZeneca, Co chair, EFPIA Information to Patients Task Force, Macclesfield, Cheshire, UK Presentation Material (Acrobat) |
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3.03 |
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Track III: Industry and Corporate Standards-Managing Cultural Differences in a Consolidation and Harmonization Environment Sameh Farag Regional Compliance Director, MEA, Schering-Plough Corporation, Dubai Yuet-Ming Tham, Esq. Senior Regulatory Consultant, DLA Piper, Former Regional Compliance Director, Legal Division, Corporate Compliance, Pfizer Inc., Former Deputy Public Prosecutor, Singapore Michael Fadus Regional Compliance Director, Central & Eastern Europe, Schering-Plough Corporation, Lucerne, Switzerland (Moderator) Presentation Material (Acrobat) |
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5:00 p.m. |
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Adjournment and Networking Reception |
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