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 firstname.lastname@example.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.
Posted 26 July 2012 | By Alexander Gaffney, RAC
The European Medicines Agency (EMA) announced today (26 July) the release of two additional guidelines on good pharmacovigilance practices (GPhVPs) and the shuttering of its Pharmacovigilance Working Party.
In a statement, the agency said the working party has been phased out of its original charge-given to it at the time of the agency's founding in 1995-to provide advice on the safety of medicines. Its duties will now be absorbed by a newly-established Pharmacovigilance Risk Assessment Committee (PRAC), which EMA noted was a "main deliverable" of the 2012 pharmacovigilance legislation.
A list of new members involved with the PRAC did not return any members previously on the PhVWP.
In addition to announcing the final report of the PhVWP, EU regulators also said they had released the two additional Guidelines on GPhVPs: Module XV on safety communication and Module IV on pharmacovigilance audits.
Both guidelines are scheduled to come into effect in December 2012, with comments due by 21 December 2012. A further five guidelines are scheduled to be released by the end of 2012, EMA said in a statement.
Tags: Good Pharmacovigilance Practices, PhVWP, Modules, Guidelines, Latest News, safety, pharmacovigilance
Regulatory Focus newsletters
All the biggest regulatory news and happenings.