Module 5 Presentations

05/07/2024

In the UK  Statutory Instrument 2004 No. 1031 and its amendments  UK Statutory Instruments 2019 No. 744: The Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

 CT-1 and CT-3 guidance can be referred to, but only for aspects concerning the UK as sovereign country

In the European Union (EU): Clinical Trial Regulation (CTR) 536/2014 (not applicable to the UK!)

The Organisation for Professionals in Regulatory Affairs

3

What is the purpose of pharmacovigilance?

SUSARs SAEs RSI USMs DSUR

Risk mitigation measures

The Organisation for Professionals in Regulatory Affairs

4