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Session 6: PRAC Referrals – Lessons Learned
Session Chair(s)
Martin Huber, MPH, MPharm
Pharmacovigilance Risk Assessment Committee (PRAC) Vice Chair, Federal Institute for Drugs and Medical Devices (BfArM), Germany
Martin Votava, MD, PhD
Chief Medical Officer , PrimeVigilance, Czech Republic
Pharmacovigilance referrals are important tools to address concerns over the safety profile or the benefit-risk balance of a medicine or a class of medicines. This session will look into finished referrals but will also reflect on future challenges both from a regulator’s and industry perspective. The following aspects will be discussed: - Describing the evolution of referrals including recent trends - Reflecting on what can be learnt from experience gathered so far - Looking into future challenges – what can be improved?
Speaker(s)
Álmath Spooner, PhD
Director of Regulatory Policy and Intelligence, AbbVie, Ireland
Referrals at PRAC – Recent Trends and Future Challenges
Vera Tóth, MD
Medical Expert, Gedeon Richter Plc., Hungary
Implementing CHMP/PRAC Conditions: Pitfalls and Challenges
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