1. 2009 DIA US Annual Meeting GCP Session Advisory Committee Meeting
24 April 2008

2. 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

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

4. 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

5. 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

6. 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

7. 2008 GCP Track Theme
Do Disclosure, compliance, auditing and QA Activities add value and improve patient safety and data integrity?
4/24/2008

8. 2008 Session List
4/24/2008

9. 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

10. 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

11. 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

12. 2009 Call for Session Abstracts
Keep same write up? Update to be more directed in request?
4/24/2008

13. 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

14. Discussion
4/24/2008