< Back
EMWA Logo EMWA Logo

Writing Risk Management Plans

Level:
Foundation
Area:
Drug Development
Code:
DDF30
Duration:
03:30:00
Workshop profile:
Aimed at medical writers with little or no experience of writing risk management plans (RMPs), but with a basic knowledge of the overall drug development process and some experience in assessing and presenting non-clinical and clinical data on drug safety and risks. Ideally, participants with no knowledge in pharmacovigilance should attend the foundation workshop on pharmacovigilance writing (DDF32) prior to register to this workshop. Writers with more experience of RMPs should consider EMWA’s advanced workshop on the topic, DDA20.
Objective:
To learn about the structure, content and requirements of RMPs according to the ‘EU Pharma Package’, which came into force in July 2012. At the end of the workshop, participants will be able to understand the focus of RMPs, identify the right content and language for each section, and collecting informations to prepare an RMP.
Content:
This workshop will provide an overview of the preparation of RMPs according to Good Pharmacovigilance Practice (GVP). Participants will learn where to find relevant guidance and which source documents should be used while preparing RMPs within multidisciplinary teams. The most relevant drug safety concepts for RMPs (e.g. important identified and potential risk) will be explained, then the structure and content of the RMP will be presented and selected issues will be explored in exercises. Emphasis will be given to the focus, content, and data presentation of different RMP sections.