Vid Stanulovic, Aprova- an Alten Company, 56, Quai Alphonse le Gallo, 92513 Boulogne-Billancourt Cedex – France

Developmental risk management plans (DRMP) are not routinely required prior to marketing authorization application, but establishing them early in clinical development significantly streamlines management of safety data. Such a plan should not be seen as an additional burden, but rather a tool which serves as a basis to impact the development plan. The main objective is to achieve the best benefit/risk balance for the best target population.

A DRMP is a living document re-evaluated with each significant safety finding. It should typically be re-evaluated upon completion of all pre-clinical or clinical studies or significant interim safety findings. A minimum of one annual update aligned with developmental safety update reports (DSUR) is recommended in accordance with CIOMS VI and VII reports.

It is practical to create a DRMP according to the structure expected in post-marketing, including the safety specifications already mandatory in the EU since 2005. This allows a seamless transition and ensures the plan is already implemented and road-tested at the time of marketing authorization application. The focus of a DRMP is on “identified and potential risks”; minimizing the impact of already identified while further evaluating the findings indicating potential risks.

Study subjects were traditionally seen as passive players before risk management approach, but their role as key stakeholders is now increasingly recognized in the new EU regulation.

They should play an even more important role in timely recognition of early signs and symptoms as well as in reporting of adverse events.

Practical examples of prevention/minimisation actions during the development will be discussed to demonstrate their effectiveness and especially with the patients’ involvement.

Learning Objectives:
• Propose methods to guide the risk management activities throughout the developmental cycle
• Streamline decision-making based on emerging safety data
• Highlight the role of Pharmacovigilance in Development Plan

Keywords: RMP, DSUR, CIOMS VI and VII, Risk minimisation, Safety specifications, Pharmacovigilance