The first meeting of the Pharmacovigilance and Risk Assessment Committee (PRAC) of the European Medicines Agency took place
26.07.2012
The European Medicines Agency (EMA) held from 19 to 20 July 2012 in Brussels a founding meeting of the Pharmacovigilance and Risk Assessment Committee (PRAC). PRAC was founded according to the new pharmacovigilance legislation that came in effect in the European Union from July 2, 2012.
The Pharmacovigilance and Risk Assessment Committee (PRAC) will have an important role in monitoring the safety of medicines in the European Union and its functioning will be entirely transparent, which involves a proactive information publishing on safety issues, holding of public consultations and publishing of Committe's programmes and minutes held. The EMA's Executive Director, Professor Guido Rasi stated that PRAC with its actions would additionally reinforce the existing system of the safety of medicines for human use in the European Union.
The list of Committee's members and the programme of the founding meeting is available on the official webpages of the European Medicines Agency (EMA). The next meeting of the Pharmacovigilance and Risk Assessment Committee will take place in September this year.
By the date of accession, Croatia participates as an active observer with two delegates in the PRAC meetings, the Head of Agency, Viola Macolić Šarinić, MD, PhD, clinical pharmacologist and toxicologist and an Agency's expert, Marin Banovac, MPharm.
More information on the new pharmacovigilance legislation, prepared by the European Medicines Agency is available below.
