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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 - PASS (Post-Authorisation Safety Studies) in Europe
Michelle Bulliard, BSN
Vice President, Global Head Real-World Evidence Strategy Unit, IQVIA, Switzerland
Moderator: Topic #2 - Informatic Insights into Drug Safety
Keith K. Burkhart, MD
Senior Advisor for Medical Toxicology, DARS, OCP, OTS, FDA, United States
Moderator: Topic #3 - Implementing the IND Safety Reporting Rule in a Global Environment
Marsha Millikan, RPh
Advisor, Expedited Reporting Global Patient Safety, Eli Lilly and Company, United States
Moderator: Topic #4 - Benefit-Risk: Finding the Optimal Balance
Elizabeth E. Garrard, PharmD
Executive Vice President, Global Safety Operations , Clinipace Worldwide, United States
Moderator: Topic #5 - Has the EU Pharmacovigilance Legislation Resulted in Improved Patient Safety Outcomes?
Saad Shakir, MD, FFPM, FISPE, FRCP
Pharmacovigilance Physician and Pharmacoepidemiologist, ADROITVIGILANCE, United Kingdom
Moderator: Topic #6 - Building Better Foundations for Patient Decision-Making
James A. Seaton
Executive Consultant, Seaton Associates, LLC, United States
Moderator: Topic #7 - Using the EMA Designated Medical Events List to Identify Suspected Adverse Events
Mariette Boerstoel-Streefland, MD, MBA, MS
Senior Vice President, Patient Safety Officer , Bristol Myers Squibb, United States
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