Herve Le Louet
Member for the European Commission of the Pharmacovigilance Risk Assessment
European Medicines Agency
•Obtaining approval for Risk Management Plans and Risk Minimisation Plans
•Highlights from the Pharmacovigilance Risk Assessment Committee (PRAC)
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.