Representation on the PRAC (EMA)

Pharmacovigilance Risk Assessment Committee (PRAC)

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency is responsible for assessing all aspects of risk management of human medicines, including the detection, assessment, minimisation and communication of the risk of adverse reactions, while taking the therapeutic effect of the medicine into account.

The PRAC consists of scientific experts from each Member State of the European Economic Area (EEA), who meet on a monthly basis at the European Medicines Agency (EMA).

Luxembourg representatives

The PRAC member and alternate for Luxembourg are:

• Anne-Cécile Vuillemin, Member
• Magdalena Wielowieyska, Alternate

Their declarations of conflicts of interests are published on the EMA website.

Highlights of monthly meetings

The EMA publishes the highlights of each PRAC meeting on its website: recommendations regarding risk management measures for medicinal products, as discussed during the meeting.

Safety communications at national level

Marketing authorisation (MA) holders, as well as by the pharmacovigilance department of the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments - DPM) may issue communications regarding the safety of medicinal products authorised in Luxembourg to healthcare professionals, depending on the subject area and context.