EU PV, Legislation, GVP, changes, Drug Safety

EU PV Legislation & GVP Modules: Challenges

At the 2014 World Drug Safety Congress Americas, Dr Janet Hormbrey, Merck Sharp and Dohme, gave a presentation on “EU PV Legislation & GVP Modules: Challenges”. Download and learn: GVP Implementation Upcoming Modules Implementation Challenges Module V – Risk Management Plans Module VII – Periodic Safety Update Report Module VIII – Post Authorisation Safety Studies Module IX – Signal Management …

Download: Presentation ‘CCDS, PSUR, RMP, DSUR, signal validation: Interrelations, modules and impact of the new GVP’

Véronique Basch, Executive Director, Global Pharmacovigilance, United BioSource Corporation, spoke at last year's World Drug Safety Congress Europe. I thought you might be interested in downloading her presentation on ‘‘CCDS, PSUR, RMP, DSUR, signal validation: Interrelations, modules and impact of the new GVP' for free. Download the presentation here. If you are interested in the topics discussed you might be …

Recent updates: EU pharmacovigilance legislation

I caught up on how the EU pharmacovigilance legislation has been progressing today on the EMAs website. I wanted to highlight a few of the most recent developments that will be affecting the pharma industry. There is lots of information being released to help guide, advise and influence the integration of the new legislation into pharma's pharmacovigilance strategy and operations. …