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Session 0107: JOURNEY TOWARD PROACTIVE GCP COMPLIANCE
Session Chair(s)
Helen Li, MD, MBA
Director, Emerging Market QA Asia Lead
Pfizer Medical, China
The journey toward proactive GCP compliance is long and challenging. In this session, the regulatory agencies from China, US, and Europe will share proactive approaches, requirements, and progress in GCP inspections, challenges, and trend in global initiative toward GCP compliance. FDA and EMA GCP inspection updates will be shared and discussed.
Speaker(s)
CFDA Updates
Representative Invited
China
Update from FDA on GCP Compliance
Leslie Ball, MD
FDA, United States
Assistant Commissioner and Deputy Director, OIP, OC
Facts and Figures of GCP Inspections Conducted - EMA Perspective
David Cockburn
European Medicines Agency, Netherlands
Head of Manufacturing and Quality Compliance Service
GCP Compliance, Challenges, Strategies and Experiences
Vincent Yeung, PhD, MBA, RPh
MHRA, United Kingdom
GCP Operations Manager, Inspection, Enforcement, and Standards Division
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