Overview
Participants will be provided with preparatory material to facilitate their learning process at the group exercises onsite.
Participants are required to bring their laptops with them for this course.
This course will give you an overview on the essential principals for Benefit-Risk Management and RMP & PSUR writing.
In the first part of the course there will be tackled the legislation environment that allows the development of Benefit-Risk Management. Additionally, the theoretical material will be supported by various practical examples from which attendees will be able to extract the knowledge needed to be applied in different situations in their company. The second and third part of the module will present the facts and practical aspects of the RMP management, all explained based on the GVP module V, VII and XVI suggestions.
This course will also present the most up to date recommendations from EU and global agencies, aspects that each industry representative needs to understand in order to facilitate the medicine development life cycle.
It is possible to register for each part separately:
- Benefit-Risk Management
- EU-RMP Creation
- Medical Writing of Periodic Safety Update Reports (PSUR/PBRER)
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