戻る Agenda
Forum on Global Pharmacovigilance
Session Chair(s)
Doris Irene Stenver, MD, MPA
Independent Pharmacovigilance Adviser
Unique Advice, Denmark
In this session a comparison of safety surveillance in the EU and USA, based on experiences with signal management, an outline of authorities’ expectations to PSURs and an update to the WHO´s Smart Safety Surveillance (3S) strategy will be provided.
Learning Objective : • Comparison of safety signals of 2017 identified by PRAC and FDA Adverse Event Reporting System (FAERS) to know about similarity and difference in approach of signal detection of two regulatory medicines agencies. • Comparison of the post-authorisation safety surveillance for medicinal products in the European Union and the United States of America
Speaker(s)
Comparison of the Management of Safety Signals between EU and USA for 2017
Arpit Vallabhbhai Vachhani, MD
Mylan Pharmaceuticals Private Limited, India
Deputy Manager
Periodic Safety Reports: What are the Authorities Expectations?
Menno Van Der Elst, PHARMD, PHD
MEB, Netherlands
Head of EU Committees Department
Update on the WHO Triple S Initiative
Shanthi Pal, DRSC, MPHARM
WHO, Switzerland
Group Lead, Medicines Safety, Safety & Vigilance