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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)
Valerie E. Simmons, MD, FFPM
Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom
Moderator: Topic #1 – Transition to the Evolving EU PVLegislation
Mick Foy
Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom
Moderator: Topic #2 – Tell it to the Regulator: Share Your Challenges and Successes on Implementation of the EU PV Legislation
John A. Saunders
Sr. Business Systems Consultant, Abbvie, Inc., United States
Moderator: Topic #3 – FDA Project JumpStart
Roger A. Goetsch, PHARMD, RPH
Pharmacist, Office of Surveillance & Epidemiology, CDER, FDA, United States
Co-moderator: Topic #4 – eReporting
Suranjan De, MBA, MS
Deputy Director, Regulatory Science, OSE, CDER, FDA, United States
Co-moderator: Topic #4
Marie Lindquist
Director, Uppsala Monitoring Centre, Sweden
Moderator: Topic #5 – VigiAccess – The Public Access to the WHO ICSR Database
Jamie Wilkins, PHARMD
Head, Risk Management Center of Excellence, Pfizer Inc, United States
Moderator: Topic #6 - Triggers for Modifying REMS
Sonja Brajovic, MD
Medical Officer, OSE, CDER , FDA, United States
Moderator: Topic #7 - MedRDA Coding and Suspect Product Reporting
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