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EMA’s Pharmacovigilance Risk Assessment Committee gains new members

Filip Babylon to represent HCP organisations and Albert van der Zeijden to represent patient organisations

EMA PRAC Albert van der ZeijdenThe European Medicines Agency's (EMA) newest committee - the Pharmacovigilance Risk Assessment Committee (PRAC) - has added two new members.

Filip Babylon, president of the Belgian Pharmaceutical Association (APB), will represent healthcare professionals' organisations and Albert van der Zeijden (pictured right), chairman of the International Alliance of Patients Organisations (IAPO), will represent patient organisations.

The PRAC was formed as part of European pharmacovigilance legislation implemented last year, and had its first meeting in July 2012.

Its objective is to assess and monitor safety issues for human medicines, giving recommendations for consideration by the Committee for Medicinal Products for Human Use (CHMP).

Its current chair is Dr June Raine of the UK's Medicines and Healthcare products Regulatory Agency (MHRA).

Its new members Babylon and van der Zeijden will participate in the PRAC from April 2013.

The EMA said: “Their role is to bring the views, concerns and experiences of patients and doctors to the PRAC's scientific considerations thus enriching its decision-making.”

Their respective alternates are Kirsten Myhr, from the Norwegian Board of Health, and Marco Greco, from the European Federation Crohn's and Ulcerative Colitis Associations.

12th March 2013

From: Regulatory



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