20 – 21 September 2016
Marina Bay Sands, Singapore, Singapore

Herve Le Louet


Member for the European Commission of the Pharmacovigilance Risk Assessment
European Medicines Agency


09:10 Risk Management Plans (RMP) : Examining European PV Legislation

Obtaining approval for Risk Management Plans and Risk Minimisation Plans
Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)


11:20 Updates from ISoP’s Special Interest Group on Risk Minimization Methods for Asia


Since the 2015 International Society of Pharmacovigilance (ISoP)’s Prague meeting, the newly formed Special Interest Group is venturing into designing novel methods suitable for a large array of health care systems. Gain firsthand insights on the Post-Approval Vigilance Program (PAVP) concept. Hear from the relevant authorities on the latest progress and operational aspects of these customizable methods that are highly scalable, flexible and Risk-adjusted. Discover how this new programme addresses the diverse needs of non-ICH Asian countries and strategies on overcoming the reluctance of healthcare professionals in reporting suspected ADRs.



Check out the incredible speaker line-up to see who will be joining Herve.

Download The Latest Agenda