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Wednesday, February 6 • 12:00 - 13:15
#S0302: Forum on Global Pharmacovigilance

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Component Type: Session

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.


Doris Irene Stenver, MD, MPA


Comparison of the Management of Safety Signals between EU and USA for 2017
Arpit Vallabhbhai Vachhani, MD

Periodic Safety Reports: What are the Authorities Expectations?
Menno Van Der Elst, PharmD, PhD

Update on the WHO Triple S Initiative
Shanthi Pal, DrSc, MPharm

avatar for Menno Van Der Elst

Menno Van Der Elst

PRAC member, Medicines Evaluation Board
Menno van der Elst is PRAC member for the Netherlands. He was trained as community pharmacist and obtained his PhD at Utrecht University at the Department of Pharmaceutical Sciences. Menno joined the MEB in 2007 as pharmacovigilance assessor. He participated in the PhVWP since 2009... Read More →

Shanthi Pal

Group Lead, Medicines Safety, Safety & Vigilance, WHO
Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative... Read More →
avatar for Doris Stenver

Doris Stenver

Chief Medical Officer, Danish Medicines Agency
Doris joined the Danish Medicines Agency in June 1998, initially as senior medical officer; in 2002 appointed chief medical officer (current position). She was member of the EU Pharmacovigilance Working Party from June 1998 until July 2012. Since July 2012 she has been member of the... Read More →
avatar for Arpit Vachhani

Arpit Vachhani

Senior Drug Safety Physician, APCER Life Sciences
Dr. Arpit is a Physician by training, having done M.D in Pharmacology. He has more than 4 years of experience in Pharmacovigilance. Dr. Arpit is currently working as senior safety physician for aggregate reports at APCER Life Science, Ahmedabad India. His previous PV experience includes... Read More →

Wednesday February 6, 2019 12:00 - 13:15 CET
E2 Austria Center Vienna Bruno-Kreisky-Platz 1 1220 Vienna Austria
  03 Pharmacovigilance, Session
  • Featured Topics Pharmacovigilance
  • Tags Session