Module 6

1 Introduction to PV Regulation ICH CIOMS and definitions

2 Pre-marketing drug safety – Clinical Trials

3 Postmarketing PV-Safety overview

4 Risk Mitigation

5 From Signal to ADR – detection and evaluation

6 Mechanisms and classification of ADRs

7 Benefit-risk

8 PE lecture Oct18 MD

9 Maintaining a PV System_ Ruth Casserley

ema-post-authorisation-procedural-advice-users-centralised-procedure_en

guideline-gvp-module-viii-post-authorisation-safety-studies-rev-3_en.pd

Session 6 Programme