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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
NIKOLAS TSIAKKAS AND CO OE, 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)
EMA GVP on RMM: Updates from a Regulator
Nuria Semis-Costa, MSc
European Medicines Agency, Netherlands
Scientific Specialist (Risk Management)
Signaling: EVDAS
Achint Kumar Gupta, DrMed, MD
Incyte, Netherlands
EU / UK QPPV
EFPIA Updates: Feedback from Regulation Implementation Public Consultation
Judith Weigel, MSc
vfa - Association of Research-Based Pharmaceutical Companies, Germany
Pharmacist, Pharmacovigilance/ Interface Regulatory Affairs,
ICH Updates
Vicki Edwards, RPh
Abbvie, United Kingdom
Vice President, Pharmacovigilance Excellence and International QPPV
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