Panos Tsintis, NDA Group Medical Advisor and Advisory Board member, will present at the DIA Risk Management Workshop in Japan, 13-14 March in Tokyo. Panos will present two sessions on: ‘Risk Management in EU – Learning Points from Pioneers’ and an ‘Overview of EU Risk Management and Regulations’.
For the first session, Panos will explain the contents and system of EU Risk Management in the real world. Topics will include the Safety Specification, which is a core element of RMP; the necessity and/or difference of PvP and risk minimization activities (RMPs) corresponding to nature and degree of risks; methodology for completing RMAs; and a concept of Benefit Risk Balance assessment from both the perspectives of RMP development and from reviewer.
There is a difference in the understanding of RMPs between professionals in pharmaceutical companies and health authorities, and so the workshop is designed to bring them together and discuss RMP strategies, covering key topics including how to create a useful RMP for medical professionals.
The following day, Panos will present on Overview of EU Risk Management and Regulations, addressing important items in relation to PRAC, PBRER, and the integration of RMP activities, and will share the advantages and key issues. The aim is to give attendees a deeper understanding of what it is beyond RMP.
To find out more, please click here
Dr Panos Tsintis
NDA Group Medical Advisor and Advisory Board member