戻る Agenda
Session 1: Overview of the Clinical Trials Regulation Environment
Session Chair(s)
Karina Griffiths
Senior Director – Head, Clinical Trial Regulatory Operations
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
Senior Director – Head, Clinical Trial Regulatory Operations