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 raps@raps.org 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.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
RAPS recognizes that the current situation in Ukraine impacts our members and customers on many levels. If you are directly impacted by the current situation in the region and are challenged to meet your deadlines or obligations to RAPS, please reach out to raps@raps.org so that we can defer those challenges. Your health and safety are paramount to us.
Posted 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