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Session 2: Hot Topics from Industry Perspective
Session Chair(s)
Vicki Edwards, RPh
Vice President, Pharmacovigilance Excellence and International QPPV
Abbvie, United Kingdom
This will be year three 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)
New Paediatric Guideline
Representative Invited
MSD
Module IX – Signal Management
Sue Rees, MS
Sue Rees Consultancy Ltd, United Kingdom
Director
Clinical Trials Regulation and RSI
Esteban Herrero-Martinez, PhD
AbbVie, United Kingdom
Director Regulatory Policy and Intelligence
Module VI Updates
Peter De Veene, MD
MSD Belgium, Belgium
GQPPV