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Luncheon in Exhibit Hall and Round Table Discussions
Session Chair(s)
Round Table Discussions
United States
There will be a 30-minute session for a limited number of participants to join round table discussions during the lunch break. Key thought leaders will help facilitate the discussion.
Speaker(s)
Moderator: Topic #1 – Transition to the Evolving EU PVLegislation
Valerie E. Simmons, MD, FFPM
Eli Lilly and Company Ltd, United Kingdom
Senior Medical Fellow, Global Patient Safety
Moderator: Topic #2 – Tell it to the Regulator: Share Your Challenges and Successes on Implementation of the EU PV Legislation
Mick Foy
Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Director of Delivery
Moderator: Topic #3 – FDA Project JumpStart
John A. Saunders
Abbvie, Inc., United States
Sr. Business Systems Consultant
Co-moderator: Topic #4 – eReporting
Roger A. Goetsch, PharmD, RPh
FDA, United States
Pharmacist, Office of Surveillance & Epidemiology, CDER
Co-moderator: Topic #4
Suranjan De, MBA, MS
FDA, United States
Deputy Director, Regulatory Science, OSE, CDER
Moderator: Topic #5 – VigiAccess – The Public Access to the WHO ICSR Database
Marie Lindquist
Uppsala Monitoring Centre, Sweden
Director
Moderator: Topic #6 - Triggers for Modifying REMS
Jamie Wilkins, PharmD
Pfizer Inc, United States
Head- Risk Management Center of Excellence
Moderator: Topic #7 - MedRDA Coding and Suspect Product Reporting
Sonja Brajovic, MD
FDA, United States
Medical Officer, OSE, CDER
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