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Session 6: Hot Topics in Pharmacovigilance
Session Chair(s)
Gemma Jimenez Sese
Senior Director, Deputy EU QPPV, AstraZeneca, Spain
Nicolas Tsiakkas, MD
Scientific Director, Greece
This will be year seven for this very popular session. Typically, the session invites speakers who are leading discussions between industry trade associations and Regulatory Authorities on the key issues of the moment. The session provides insight into what are the hot topics under discussion, what progress has been made and what are the next steps. The session is of value to participants from both large and small companies alike as there is limited attendance possible at the public meetings with EMA so this is a fantastic opportunity to hear about these topics from individuals who are directly involved. The session consists of a series of several concise presentations that cover the key messages. This session is always a crowd pleaser!
Speaker(s)
Nuria Semis-Costa, MSC
Scientific Specialist (Risk Management), European Medicines Agency, Netherlands
EMA GVP on RMM: Updates from a Regulator
Achint Kumar Gupta, DrMed, MD
EU / UK QPPV , Incyte, Netherlands
Signaling: EVDAS
Judith Weigel, MSC
Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs, , vfa - Association of Research-Based Pharmaceutical Companies, Germany
EFPIA Updates: Feedback from Regulation Implementation Public Consultation
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
ICH Updates
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