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Round Table Luncheon Discussions
Session Chair(s)
Round Table Discussions
United States
There will be a 30 minute session for a limited number of participants to join roundtable discussions during the lunch break. Key thought leaders will help facilitate the discussions.
Speaker(s)
Moderator: Topic #1 - Electronic Reporting and E2B
Sanjay K Sahoo
FDA, United States
Associate Director, Tools, Technology, and Innovation, OCS, OTS, CDER
Co-moderator: Topic #1
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
Moderator: Topic #2 - MedDRA Coding Data Quality
Sonja Brajovic, MD
FDA, United States
Medical Officer, OSE, CDER
Co-moderator: Topic #2
Judy Harrison, MD
United States
Chief Medical Officer
Moderator: Topic #3 - Patient Safety in Phase I Trials
E. Stewart Geary, MD
Eisai Co., Ltd., Japan
Senior Vice President
Moderator: Topic #4 - Global Management of Reference Safety Information
Stephen Knowles, MD, MRCP
Halozyme Therapeutics, United States
Chief Medical Officer
Moderator: Topic #5 - Pharmacovigilance Outsourcing Decision Making
Annette S. Williams, MBA, RPh
IQVIA, United States
Vice President, Pharmacovigilance
Moderator: Topic #6 - Customer Engagement Program Data for Pharmacovigilance Efforts
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Moderator: Topic #7 - Pharmacovigilance for Biosimilars
Thomas Felix, MD
Amgen Inc., United States
Medical Director, R&D Policy, Global Regulatory Affairs and Safety
Moderator: Topic #8 - Comparisons Between FDA and EMA/MHRA Pharmacovigilance Inspections
Jill W. Buckley, PharmD
Rutgers, the State University of New Jersey, United States
Adjunct Assistant Professor
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