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    PRE-CONFERENCE SYMPOSIA
   Thursday, May 28, 2009






7:00 a.m.



Congress Registration




8:00 a.m.



PRECONFERENCE I






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)



9:45 a.m.



Preconference I Adjournment










8:00 a.m.



PRECONFERENCE II






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)



9:45 a.m.



Preconference II Adjournment










8:00 a.m.



PRECONFERENCE III






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)



9:45 a.m.



Preconference III Adjournment





    International Pharma Congress Day One
    Thursday, May 28, 2009






10:00 a.m.




Welcome and Overview of Day I - Morning Plenary Session

Sue Egan
Vice President Compliance, AstraZeneca PLC, London, UK (Co chair)



10:15 a.m.




Opening Keynote Address

Nicola Braggio
Marketing Company President, Astrazeneca Italy, Milan, Italy
No Presentation Provided



10:45 a.m.




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



11:15 a.m.




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



12:15 p.m.



Networking Luncheon



1:30 p.m.



Concurrent Sessions I


1.01  



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)



1.02  




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



1.03  




Industry and Corporate Standards-Transparency, Including:
  • Current State of disclosure laws-global implications
  • Where are manufacturers today?
  • Data and systems challenges
  • Current infrastructure is not sufficient to sustain
  • Regulations present opportunities
  • What should you be doing now?
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)

Jennifer Colapietro
Director, Pharmaceutical and Life Sciences Advisory Services, PricewaterhouseCoopers LLC, Florham Park, NJ, USA
Presentation Material (Acrobat)



2:30 p.m.




Transition Break


2:45 p.m.



Concurrent Sessions II


2.01  



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)



2.02  




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



2.03  




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)



3:45 p.m.




Transition Break


4:00 p.m.



Concurrent Sessions III


3.01  



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)



3.02  




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)



3.03  




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)



5:00 p.m.




Adjournment and Networking Reception




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