Clinical Trials Conduct: PV perspective - EU Clinical Trials Regulation and publication of Risk Management Plans – impact on DSURs and RMPs

1:35 PM - 2:00 PM

The Clinical Trials Regulation harmonises the processes for assessment and supervision of clinical trials throughout the EU. It entered into application on 31 January 2022. The regulation has had an impact on processes that are relevant for the creation of the Development Safety Update Report (DSUR) and that have become frequent issues in health authority inspections.

Recently, EMA has announced to immediately make not only the summary of a Risk Management Plan (RMP), but the full text RMP of a centralised, authorised product available to the public. 

This session discusses the impact of these changes in regulations on the DSUR and RMP writing process using real-live examples and possible solutions.