trilogy, drug safety, risk

Download whitepaper: Risk management plans – New challenges for a new era

  The risk management plan (RMP) is currently a hot topic and the focus of much discussion in industry due to the recent overhaul of the RMP guidance template. The complexity of the new RMP has introduced many challenges in preparing a high quality document compliant with all requirements, not least in the production of the newly legislated Part VI.2 …

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 …