This article aims to share some key considerations when defining the strategy for the preparation of a risk management plan (RMP). The RMP is required to be submitted when applying for an EU marketing authorisation application (MAA). Advice is offered to applicants and medicinal product developers to maximise the utility of the RMP, in both the marketing authorisation approval process and in the post-marketing setting.
The following two scenarios are described: when RMP preparation is initiated early during the product development (mostly applicable to new chemical/new biological entities, NCEs/NBEs), and when the RMP is prepared later, ie, at the time of MAA (mostly applicable to generics or hybrid applications).
February 2017 - Regulatory Rapporteur-TOPRA
Alina TUDOR, Director Vigilance Operations
Alina TUDOR is Director, EU QPPV in the Vigilance Unit at Voisin Consulting Life Sciences. Alina is responsible for the management and maintenance of different pharmacovigilance systems for all types of products (drugs, biologics, etc).
Julie Taccoen, Senior Regulatory Scientist Drugs & Biologics
Participates in the design and implementation of EU regulatory strategies and development plans for drugs and biologics, actively involved in regulatory activities from late development to MAA and post-approval.