Module 3 Presentations

07/05/2024

Purpose of a Clinical Trial ?

Quality

Efficacy

Safety

Benefit/ Risk

The Organisation for Professionals in Regulatory Affairs

5

Directives / Regulations for IMP

EU: 536/2014 – Clinical Trials Regulation (EU CTR) • Came into force on 31st Jan 2022 • Supersedes Clinical Trial Directive 2001/20/EC & GCP directive 2005/28/EC • Transition periods – 1 year for new applications, 3 years for ongoing clinical trials • GCP inspection procedures: Commission Implementing Regulation (EU) 2017/556 • GMP for Investigational Product: Delegated Regulation (EU) 2017/1569 • Safety assessment of clinical trials: Implementing Regulation (EU) 2022/20

The Organisation for Professionals in Regulatory Affairs

6

6

3