2009 DIA US Annual Meeting GCP Session Advisory Committee Meeting 24 April 2008

Agenda Review Committee roles Review Process for selecting sessions Review 2008 Sessions Review 2009 Session Theme, Call for abstracts and Session Ideas Brainstorm additional ideas 4/24/2008

Advisory Committee Role Bring Ideas for session themes, chairs and speakers Review session topic lists and provide input Submit session abstracts 4/24/2008

2009 Session Mega Tracks 3 MEGA TRACKS What is a Mega Tracks? A mega track is where multiple tracks are encouraged to develop sessions within their interest area but also collaborate to eliminate overlap of similar session topics and promote broader discussion and fuller understanding of the topics presented. Advertising/Marketing/Medical Communications MegaTrack New for 2009! AD – Advertising, MA – Marketing, MC - Medical Communications Clinical Research MegaTrack AHC/IS-Academic Health Centers/Investigator Sites New for 2009! CR - Clinical Research and Development/Clinical Supplies New for 2009! OS – Outsourcing, PM/FI-Project Management/Finance Information Technology MegaTrack EC-eClinical, ERS/DM – Electronic Regulatory Submissions/Document Management, CDM - Clinical Data Management, IT - Information Technology, VA – Validation 4/24/2008

2009 Session Tracks 22 “Standard” Tracks BT-Biotechnology CMC/GMP - Chemistry, Manufacturing and Controls CP - Clinical Safety and Pharmacovigilance GCP - Good Clinical Practices IMP/EBM - Impact (Impact of Medical Products and Therapies)/Evidence-Based Medicines MW - Medical Writing NC - Nonclinical Laboratory Safety Assessment   NHP - Natural Health Products PP - Public Policy/Law RA - Regulatory Affairs RD - R&D Strategy ST - Statistics TR – Training 4/24/2008

Task List Call for Abstracts: Ask for sessions that are in line with our theme and topic ideas Evaluate 2008 Sessions Recruit Session Chairs Review abstracts submitted Organize by session topic Meet with other session chairs Finalize selections 4/24/2008

2008 GCP Track Theme Do Disclosure, compliance, auditing and QA Activities add value and improve patient safety and data integrity? 4/24/2008

2008 Session List 4/24/2008

2008 Call for Session Abstracts GCP - Good Clinical Practices The topics/issues related to the good clinical practices aspects of both global and local clinical trials, including internal QA programs and audit outcomes, regulatory inspection results and processes (FDA, EMEA, other countries, comparison of FDA and EMEA), discussion of the latest issues in the clinical trial process including impact of new developments in GCP to speed up the clinical trial process, human subject protection issues such as informed consent and IRB/ethics committee procedures, compliance and oversight of clinical trials, use of electronic systems in clinical trials, including validation and audit of these systems, detection and prevention of fraud and misconduct in clinical trials, financial aspects of clinical trials, GCP inspections, training of investigators, IRBs, and industry personnel, auditing practices and techniques, and discussion of evolving international clinical trial disclosure law and guidance and effects on the clinical trial life cycle. 4/24/2008

2009 GCP Track Theme Do Disclosure, compliance, auditing and QA Activities add value and improve patient safety and data integrity? Modify Theme? 4/24/2008

2009 Session Topic Ideas Session # 2009 Session Topic Idea 1 Are auditors really independent? Can they pass the test? 2 Off-shoring: how to tackle and address the quality management challenges 3 Are we learning from our mistakes? A review of recent FDA inspection findings. 4 Who should evaluate Vendor Qualifications? Company functional team vs QA? 5 Challenges of auditing in emerging countries 6 The Auditor as consultant: Terminate that site! 7 Clinical Trial Disclosure: Does it really inform the patients? 8 Is my company compliant with Clinical Trial Disclosure Law? 9 Review of Regulatory Agency Audit Reports 10 Does the audit program really contribute to enhanced quality and patient protection? 11 12 13 4/24/2008

2009 Call for Session Abstracts Keep same write up? Update to be more directed in request? 4/24/2008

Points to Consider for Sessions Audience level Basic or Advanced? Town Halls Debates; present different points of view and discuss? Panel discussions? Law updates/discussions 4/24/2008

Discussion 4/24/2008