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HALMED host of the Pharmacovigilance and Risk Assessment Committee informal meeting


The Agency for Medicinal Products and Medical Devices (HALMED) is host of an informal meeting of the European Medicines Agency’s (EMA) Pharmacovigilance and Risk Assessment Committee (PRAC), opened today in Dubrovnik. The meeting of the central EMA’s committee for review and safety monitoring of medicines for human use in the European Union is taking place from 22 -23 May 2014 and organised under the Greek Presidency of the EU.

Participants were addressed by Viola Macolić Šarinić, MD, PhD, the Head of HALMED and Dr June Raine, the PRAC President and Head of the MHRA’s (Medicines and Healthcare Products Regulatory Agency) Vigilance and Risk Management Department. In her opening speech, Dr Raine acknowledged the Croatian PRAC members for their significant contribution to the Committee’s work, highlighting the exceptional success of a new Member State.

Presentations and discussions emphasize the current topics in medicine’s safety such as efficacy and risk minimisation measures, risk minimisation plans for generics, safety signal detection, referral procedures, importance of pharmacoepidemiology and pharmacogenomics for pharmacovigilance, availability of centrally authorised products in smaller EU member States and the collaboration of the PRAC with the EMA’s Committee for Human Medicinal Products (CHMP).

The meeting is attended by approximately 50 experts from 22 EU Member States and three HALMED members participate as speakers.

The PRAC is an EMA’s committee established under the new pharmacovigilance legislation that entered into force in the EU in July 2012 with the aim to improve the patient protection and promote the public health through strengthening the EU pharmacovigilance system. The PRAC members are experts from the EU Member States (national medicines agencies) and patient and healthcare professionals members delegated by the European Commission. Two HALMED representatives participate in the PRAC’s work as active members.

The role of the PRAC is to reinforce the existing monitoring system of human medicinal products in the entire EU. The Committee is responsible for detection, assessment, minimisation and communication related to risks from adverse reactions, taking account of the medicine’s therapeutic effect. It is responsible for creating and validating post-marketing safety investigation, as well as for pharmacovigilance inspection. The main PRAC responsibility is preparation of recommendations related to pharmacovigilance issues and risk management systems whose’ effectiveness it controls. The Committee is competent for providing scientific review in cases where a Member State or the European Commission initiate an EU referral procedure to review the safety or benefit/risk ratio for certain medicine or group of medicines.

This meeting will be an opportunity for experience sharing and exchanging views among experts from different institutions and Member States with the aim to improve the safe use of medicines in the EU.

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HALMED host of the Pharmacovigilance and Risk Assessment Committee informal meeting