CRED Understanding Clinical Development 2024

09/10/2024

Why do we do this ? • It’s the law • Regulations • Pre-approval • Post approval • Company policy • Patient safety

The Organisation for Professionals in Regulatory Affairs

5

Regulations (Clinical trial safety requirements)

• Europe (in period of transition)

• Clinical Trials Directive 2001/20/EC.

• EudraLex - Volume 10 Clinical trials guidelines

• Detailed guidance on the collection, verification and presentation of adverse reaction reports arising from clinical trials on medicinal products for human use (CT-3) • New legislation European Council Regulation (EU) No 536/2014 implemented Jan 2022 with transition period until Jan 2023 for approvals and Jan 2025 for other requirements e.g. safety

USA

•

• Federal regulations and multiple guidances

Japan

•

• PMDA regulations (ICH compliant)

The Organisation for Professionals in Regulatory Affairs

6

3