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



HerveLe Louet is Professor of clinical Pharmacology. He is currently the head ofPharmacovigilance Federation and the Co-chair of thePharmacoepidemiology unit ofParis University Hospitals (AP-HP). He is an hepatologist by training and a PhDin Pharmacogenetic from the Paris University. He worked on liver metabolismassessment in patients with different liver conditions and on the drug inducedmitochondria toxicity. He also worked on serious cutaneous adverse reactions(SCAR), especially on causality assessment for Steven Johnson Syndrom and ToxicEpidermal Necrolysis. He has learning activities in several universitiesworldwide.

Heis a co-opted member by the European Commission of the Pharmacovigilance RiskAssessment Committee (PRAC) at the EuropeanMedicines Agency. Heis the President of the International Society of Pharmacovigilance (ISoP) andVice President of the Council for International Organizations for MedicalSciences (CIOMS). He is member of the European Network of Centers of Pharmacoepidemiologyand Pharmacovigilance (ENCEPP) and is Honorary Consultant for UppsalaMonitoring Centre (WHO). He was the advisor of the Minister of Health andSocial Security.


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