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:

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
Pharmacists
Pharmacovigilance Scientists
Pharmacovigilance Project Managers
Medical Writers
Regulatory Affairs & Product Safety Technicians
Medical Safety Officers
QPPVs

Learning objectives

At the conclusion of this course, participants will be able to:

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

Digital Learning Catalog

Download

Have an account?