International Pharma Congress: Agenda: Preconference & Day 1

	PRE-CONFERENCE SYMPOSIA Wednesday, May 28, 2008

	7:00 a.m.			Congress Registration
	8:00 a.m.			PRECONFERENCE I
				Global Compliance Program Operational Issues: Infrastructure, Monitoring, Auditing and Managing with Limited Resources Julien Durand Director, Global Compliance Implementation, AstraZeneca PLC, London, UK Andrew Hayward, Esq. Chief Counsel, Global Compliance, AstraZeneca PLC, London, UK Ethan M. Posner, Esq. Partner, Covington & Burling LLP, Former Deputy Associate Attorney General, US Department of Justice, Washington, DC, USA Sigrid Willame Vice President, Legal Affairs, UCB Group, Brussels, Belgium Keith M. Korenchuk, JD, MPH Of Counsel, Covington & Burling LLP, Washington, DC, USA (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	10:00 a.m.			Preconference I Adjournment

	8:00 a.m.			PRECONFERENCE II
				Comparing, Contrasting and Complying with the Various Pharmaceutical Global Codes of Conduct Gabor Danielfy Senior Director, Global Compliance & Business Practices, Schering-Plough Corporation, Levallois-Perret Cedex, France Presentation Material (Acrobat) Presentation Material (Powerpoint) Steve Mohr, Esq. Global Compliance Officer, AstraZeneca PLC, London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) John Bentivoglio, Esq. Partner, King & Spalding LLP, Former Special Counsel for Health Care Fraud and Chief Privacy Officer, United States Department of Justice Washington, DC, USA (Moderator) No Presentation Provided
	10:00 a.m.			Preconference II Adjournment

	8:00 a.m.			PRECONFERENCE III
				Advanced Issues in Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act Thomas H. Suddath, Jr. Partner, Reed Smith; Former Assistant United States Attorney, US Attorney's Office for the Eastern District of Pennsylvania, Philadelphia, PA, USA Ted Acosta, Esq. Principal, Ernst & Young LLP, Former Assistant Inspector General for Legal Affairs, Office of Inspector General, US Department of Health and Human Services, Paris, France (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	10:00 a.m.			Preconference III Adjournment

	8:00 a.m.			PRECONFERENCE IV
				An Overview of the United States Regulatory Environment (FDA and Healthcare) for Global Pharmaceutical Compliance Professionals Ann Leopold Kaplan, Esq. Assistant General Counsel, PhRMA, Washington, DC, USA Lynn Shapiro Snyder Senior Member, Epstein Becker & Green, P.C., Washington, DC, USA Wendy C. Goldstein, Esq. Member of the Firm, Epstein Becker & Green, New York, NY, USA (Moderator) Presentation Material (Acrobat) Presentation Material (Powerpoint)
	10:00 a.m.			Preconference IV Adjournment

	8:00 a.m.			PRECONFERENCE V
				Dangerous Documents: Finding Landmines in Your Emails and FDA Records Frances Richmond, PhD Director of the Regulatory Science Program, USC School of Pharmacy, Los Angeles, CA Nancy Singer, JD President, Compliance-Alliance LLC, Former Special Counsel, AdvaMed, Washington, DC Permission to post not granted
	10:00 a.m.			Preconference V Adjournment

	International Pharma Congress Day One Wednesday, May 28, 2008

	10:15 a.m.			Welcome and Overview of Day I - Morning Plenary Session Roeland van Aelst Executive Director, Health Care Compliance, Europe, Middle East, Africa, Johnson & Johnson, Brussels, Belgium (Co chair)
	10:30 a.m.			Pharma CEO Keynote Address Jaak Peeters President, Janssen-Cilag EMEA, Neuss, Germany Permission to post not granted
	11:00 a.m.			Setting the Stage: Crucial Issues in Global Compliance Panel Georgia Keresty Senior Vice President Pharmaceutical Compliance and Global Regulatory Affairs, Johnson & Johnson, New Brunswick, NJ, USA Steve Mohr, Esq. Global Compliance Officer, AstraZeneca PLC, London, UK Arthur Muratyan, Esq. Vice President Legal Corporate, Sanofi Aventis, Paris, France Dan Ostergaard Head of Corporate Integrity & Compliance, Novartis International AG, Basel, Switzerland Lori Queisser Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Kenilworth, NJ, USA Ted Acosta, Esq. Principal, Ernst & Young LLP, Paris, France (Moderator) Panel Discussion Only
	12:30 p.m.			Networking Luncheon
	1:30 p.m.			AFTERNOON TRACK SESSIONS The International Pharma Congress track sessions are intended to be interactive facilitated discussions. The session faculty will provide a brief overview of the issues and will set forth a series of questions and case studies to be addressed by the participants. Track I: Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act Gary F. Giampetruzzi, Esq., Deputy Compliance Officer, International Investigations and Programs, Pfizer Inc., New York, NY, USA (Co chair) Jonathon L. Kellerman, Partner - Advisory Health Industries, Pharmaceutical and Medical Device Sector, PricewaterhouseCoopers LLP, Philadelphia, PA, USA (Co chair) Track II: Pharmacovigilance and Drug Safety Ian Dodds-Smith, Esq., Partner and Co-Head, Food, Drug and Medical Devices Practice Group and Head, European Product Liability Practice Group, Arnold & Porter LLP, London, UK (Co chair) Valerie E. Simmons, MD, Qualified Person, Pharmacovigilance, Global Patient Safety, Eli Lilly & Company Ltd., London, UK (Co chair, Day I) Monika Pietrek, MD, PhD, MSc, Drug Development and Safety Expert, Weinheim, Germany (Co chair, Day II) Track III: International Clinical Trials Kathleen M. Boozang, Esq., Associate Dean and Professor of Law, Seton Hall University School of Law, Newark, NJ, USA (Co chair) Linda Horton, Esq., Partner, Hogan & Hartson LLP, Washington, DC, USA and Brussels, Belgium, (Co chair) Track IV: Practical Case Studies: Third Party Oversight, Distribution Channel Challenges and Management of Allegations and Investigations Sue Egan, Vice President Compliance, AstraZeneca PLC, London, UK (Co chair) Gerard Geneen, Compliance Officer, Pharmaceuticals Europe, GlaxoSmithKline, Brentford, Middlesex, UK (Co chair) Dave O'Shaughnessy, Compliance Officer, Pharmaceuticals International, GlaxoSmithKline, London, UK (Co chair)
	1:30 p.m.			Concurrent Sessions I
	1.01			Track I: Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act: European Laws and Regulations Relating to Promotion, Inducements and Corrupt Practices John Smart Partner, Fraud Investigation and Dispute Services, Ernst & Young LLP, London, UK No Presentation Provided
	1.02			Track II: Pharmacovigilance and Drug Safety: The European Commission's December 5, 2007 Proposal to Re-design Existing European Drug Safety Rules Outlining the Major Changes Maurits J.F. Lugard, MA, JD, LLM Partner, Sidley Austin LLP, Former Member of the European Commission Legal Service, Brussels, Belgium Presentation Material (Acrobat) Presentation Material (Powerpoint) Responses on the Consultation Christine Bendall, Esq. Consultant, Arnold & Porter LLP, London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Industry View on Practical Implications Margaret Walters Director, EU Pharmacovigilance, Merck, Sharp & Dohme Ltd., Hoddesdon, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Discussion Monika Pietrek, MD, PhD, MSc Drug Development and Safety Expert, Weinheim, Germany
	1.03			Track III: International Clinical Trials: Global Compliance Norms and European Union Focus Global Compliance Norms John R. Williams, PhD Former Director of Ethics, World Medical Association, Coordinator, Revision of the Declaration of Helsinki, Adjunct Professor, Department of Medicine, University of Ottawa and Department of Philosophy, Carleton University, Ottawa, Canada Presentation Material (Acrobat) Presentation Material (Powerpoint) European Union Focus Emmanuelle M. Voisin, PhD Principal, Voisin Consulting, Former General Manager of Quintiles France and Spain, Paris, France Presentation Material (Acrobat) Presentation Material (Powerpoint)
	1.04			Track IV: Practical Case Studies: Third Party Oversight, Distribution Channel Challenges and Management of Allegations and Investigations Sue Egan Vice President Compliance, AstraZeneca PLC, London, UK No Presentation Provided Gerard Geneen Compliance Officer, Pharmaceuticals Europe, GlaxoSmithKline, Brentford, Middlesex, UK No Presentation Provided
	3:00 p.m.			Transition Break
	3:15 p.m.			Concurrent Sessions II
	2.01			Track I: Promotion, Inducements and Corrupt Practices, including Foreign Corrupt Practices Act: Walking thru a Mock Inspection, Inspection Readiness and Response Jonathon L. Kellerman Partner - Advisory Health Industries, Pharmaceutical and Medical Device Sector, PricewaterhouseCoopers LLP, Philadelphia, PA, USA Permission to post not granted
	2.02			Track II: Pharmacovigilance and Drug Safety: Risk Management - EU and US Developments Comparing the EU and US Approach to Risk Management Daniel A. Kracov, Esq. Partner and Global Head, Pharmaceutical and Medical Devices Practice, Arnold & Porter, Washington, DC Presentation Material (Acrobat) Presentation Material (Powerpoint) Dr. Lincoln Tsang Partner, Arnold & Porter LLP, London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Industry Experience in Implementation Valerie E. Simmons, MD Qualified Person, Pharmacovigilance, and Global Patient Safety, Eli Lilly & Company Ltd., London, UK Presentation Material (Acrobat) Presentation Material (Powerpoint) Discussion John Knight, MD, FRACP Senior Medical Advisor, Benefit Risk Management, Johnson & Johnson, North Ryde, NSW, Australia
	2.03			Track III: International Clinical Trials: Current Issues in Clinical Trial Regulation and Future Reforms: EU, US, and Beyond New US Law on Clinical Trials, Gov and Future FDA Proposals Linda R. Horton, Esq. Partner, Hogan & Hartson, LLP, Former Deputy Chief Counsel and Director of International Policy, US Food and Drug Administration, Washington, DC, USA and Brussels, Belgium Presentation Material (Acrobat) Presentation Material (Powerpoint) A Perspective from the European Commission, DG Research Fergal Donnelly Directorate-General for Research, European Commission, Brussels, Belgium Presentation Material (Acrobat) Presentation Material (Powerpoint) Paule Drouault-Gardrat Partner, Reed Smith, Paris France Presentation Material (Acrobat) Presentation Material (Powerpoint)
	2.04			Track IV: Practical Case Studies: Third Party Oversight, Distribution Channel Challenges and Management of Allegations and Investigations Sue Egan Vice President Compliance, AstraZeneca PLC, London, UK No Presentation Provided Gerard Geneen Compliance Officer, Pharmaceuticals Europe, GlaxoSmithKline, Brentford, Middlesex, UK No Presentation Provided
	4:45 p.m.			Transition Break
	5:00 p.m.			Introduction to Afternoon Plenary Session Lori Queisser Senior Vice President, Global Compliance and Business Practices, Schering-Plough Corporation, Indianapolis, IN, USA (Co chair)
	5:15 p.m.			Emerging Global Compliance Issues in North America, Europe, Middle East, Africa, Asia and Latin America Gonzalo Cornejo, Esq. Vice President and Associate General Counsel, Latin America and Canada, Legal Operations International & Japan, GlaxoSmithKline, Philadelphia, PA No Presentation Provided Michael Fadus Regional Compliance Officer, Schering-Plough, Central East AG, Lucerne, Switzerland No Presentation Provided Joe Henein Managing Director, Middle East and North Africa, Wyeth Pharmaceuticals, Chairman, MEA/LAWG Ethics Committee, Dubai, United Arab Emirates No Presentation Provided Juan Francisco Millan, MD Executive Director, CETIFARMA (Pharma Industry Association), Mexico Presentation Material (Acrobat) Presentation Material (Powerpoint) Yuet-Ming Tham, Esq. Regional Compliance Director, Legal Division, Corporate Compliance, Pfizer Inc., Hong Kong No Presentation Provided Brian Riewerts Principal, Global Life Sciences Governance, Risk and Compliance Leader, PricewaterhouseCoopers LLP, Baltimore, MD, USA (Moderator)
	6:30 p.m.			Adjournment and Company Best Practice Policy and Procedure Poster Board and Exchange Reception The International Pharma Congress Networking Reception will feature the exchange and presentation of company best practice policy and procedures at poster boards throughout the Pharma Congress Exhibits.