Overview

Participants will be provided with preparatory material to facilitate their learning process at the group exercises onsite.
It is necessary to take your laptop with you.

This course is aimed at the practical aspects of the EU-RMP creation process. We will demonstrate the various uses of the EU-RMP within the lifecycle of medicinal products, medical writing process and RMP management process associated with the daily RMP job. It will provide a detailed understanding of the GVP Modules V and XVI with all potential implications for the marketing authorisation holders.
The participants will learn the best practice in medical writing of the EU-RMP. The solutions will be demonstrated in practical exercises included throughout the course.

What you will learn

The course will teach the EU-RMP creation skills, including the project management, medical writing, design, associated tactical and strategic decisions, publication, maintenance, and submission of the document.

Who should attend?

This course is intended for the professionals working within the pharmaceutical industry in pharmacovigilance, drug safety, regulatory and medical affairs or similar positions, who are involved in the medicinal product lifecycle. This course would be especially beneficial for junior and medium level experience medical writers working within the pharmaceutical industry, service providers, and research institutions.

Learning objectives

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

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
Deal with uncertainties and gaps in the data sets
Respond to regulatory authority requests effectively

Participants will complete two knowledge checks - project management exercise in writing the EU-RMP and writing exercise of the critical parts of the EU-RMP. They will obtain an individual feedback to ensure learning objectives are attained.

Plan Your Team's Professional Development

The world of health care product development is rapidly evolving. To keep you at the forefront, DIA offers a broad selection of expert-led training courses in the key disciplines of Regulatory Affairs, Clinical Research and Pharmacovigilance, as well as courses created to develop other key competencies in the area of e.g. Biosimilars or HTA.

DIA can deliver this course at your organisation on dates that suit you. Our offerings can be customised to meet your exact needs. Learn how DIA can bring our outstanding training programmes directly to you and your team.
For more information please contact EMEA@diaglobal.org.

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EU-RMP Creation