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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)
Referrals at PRAC – Recent Trends and Future Challenges
Álmath Spooner, PhD
AbbVie, Ireland
Head of Europe Regulatory Policy & Intelligence (RPI)
Implementing CHMP/PRAC Conditions: Pitfalls and Challenges
Vera Tóth, MD
Gedeon Richter Plc., Hungary
Medical Expert