Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Our new book is a comprehensive look at a vital part of medicines development and regulatory affairs. Grab your copy today!
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
| 12 November 2012
The European Medicines Agency (EMA) has released a huge number of new guidance documents regarding the format of risk-management plans (RMPs). The revised documents are an integral part of its new strategy on pharmacovigilance, which is the result legislation passed earlier in the year that overhauled the way postmarket surveillance is conducted in the EU.
The new guidances-16 in all-relate to a wide number of topics and product types, and provide an overview of how sponsors should fill out the new risk-management plan forms in the EU.
Tags: EU, pharmacovigilance