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Session 7: Hot Topics in Pharmacovigilance
Session Chair(s)
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
This will be year six 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 short, concise presentations that cover the key messages. This session is always a crowd pleaser!
Speaker(s)
Guy Demol
EU QPPV, MSD, Belgium
Update on ongoing Hot-Topics (ICH E2D, E19, EMA industry platform meeting areas for discussion)
Vicki Edwards, RPH
Vice President, Pharmacovigilance Excellence and International QPPV, Abbvie, United Kingdom
Impact of COVID-19 on Pharmacovigilance: Industry Perspective
Kiernan Trevett, MSC
Quality Policy Lead, Genentech, A Member of the Roche Group, United States
Impact of COVID-19 on Pharmacovigilance: Regulator Perspective
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