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Session 1: Overview of the Clinical Trials Regulation Environment
Session Chair(s)
Karina Griffiths
Director – Clinical Trial Application (CTA) Lead
Pfizer Ltd, United Kingdom
- Current Clinical Trial Directive & Rationale for Change
- Why a New Regulation
- What is the New EU Clinical Trial Regulation
- What supports the new Regulation
- Differences between Directive & Regulation
- Submissions Process Part I & Part II
- What are the Current Timelines for Implementation
Speaker(s)
Karina Griffiths
Pfizer Ltd, United Kingdom
Director – Clinical Trial Application (CTA) Lead
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