Benefit-Risk and Medical Writing Week
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)
What you will learn
- Exploring the new European benefit-risk management planning
- Legal possibilities for benefit optimisation and risk minimisation of products in the EU
- PSUR: regulations, format and content of the document
- PBRER: regulations, format and content of the document
- Practical aspects of planning and medical writing related to aggregate reports
Who should attend?
Professionals with experience in: pharmacovigilance, drug safety, regulatory affairs, quality assurance, risk management, medical affairs or similar positions within the pharmaceutical industry:
- Global Safety Physicians
- Drug Safety Specialists
- Experts in Pharmacovigilance
- Pharmacovigilance Scientists
- Pharmacovigilance Project Managers
- Medical Writers
- Regulatory Affairs & Product Safety Technicians
- Medical Safety Officers
- Describe safety, efficacy, and effectiveness profiles of drugs
- Plan safety and efficacy follow-up systems, including the best choice of study designs and available registries
- Present the Benefit-Risk documents to regulatory authorities and health technology assessment bodies
- Measure effectiveness of the planned actions – both risk minimisation and benefit optimisation
- Understand requirements of EU Good Pharmacovigilance Practice Module V and XVI
- Learn the best medical writing practices for EU-RMP and consistency check with other parts of the dossier
- Understand the project management challenges and budget implications of EU-RMP
- Understand interpretation and application of the ICH E2C (R2) guideline, associated Q&A, and EU GVP Module VII standards and templates
- Understand important legal and regulatory context of PBRER, including local regulatory intelligence tips