Posted on 28 Feb 2020

Webinar on managing safety concerns in DSURs, PBRERs and RMPs

Dear EMWA members,

Please join us on Thursday 5th March 2020, 14:00 CET for a webinar on Managing safety concerns in DSURs, PBRERs and RMPs by Sven Schirp, Boehringer Ingelheim International GmbH, Pharmacovigilance Corporate

To register, please click here.

Here's a brief summary:

Safety concerns are a set of important risks and missing information that are defined during clinical development and significantly impact the content of pharmacovigilance documents like the DSUR, the RMP, and the PBRER. For the RMP, the definition of safety concerns was revised with the EU Good Pharmacovigilance Practice (GVP) Module V Revision 2. This has implications for all pharmacovigilance documents and also for the management of safety concerns worldwide. After this webinar you will have a clear understanding of what safety concerns are and how to manage them in DSURs, PBRERs and RMPs.

Future webinar:

Our April webinar will be on Thursday 2nd April 2020, 14:00 CET about The obstacles to data transparency and how to overcome them by Andrea Rossi, Past President of EMWA - Medical writing, medical communications and scientific affairs consultant.

Here's a brief summary of April's webinar:

Why are most of the results included in abstracts presented at congresses not published? Why are several registered trials not reported in due time, even if data transparency is requested by editors and regulatory authorities? In this webinar, the available objective data on the lack of data transparency will be shared, together with their causes, to provide the instruments that could be applied to ensure data transparency.

Thank you!
The EMWA Webinar Team