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