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Risk Management Plan (EU-RMP) Creation

This virtual live course will teach the EU-RMP creation skills, including the project management, medical writing, design, and maintenance of the document.


Course instructor Emil Cochino, Scientific Officer, Risk Management Specialist, Office of vaccines and therapies, European Medicines Agency:
This basic and intermediate-level training is aimed primarily at providing marketing authorisation holders and marketing authorisation applicants with practical advice on risk management plans (RMP) drafting using the principles of risk assessment and management included in good pharmacovigilance practice (GVP) module V rev. 2.
Content requirements and procedural advice for RMP submission will be presented with practical examples provided, based on frequent questions from applicants, assessors, and European Medicines Agency (EMA) Risk Management Specialists.
Highlights will include types of products with different legal basis application (e.g., generics, fixed dose combination products, biosimilars). The Q&A sessions will include the response to questions received in advance or raised during the presentations.

This virtual live course is aimed at the practical aspects of the EU Risk Management Plan (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. It will provide a detailed understanding of the GVP Module V (Rev. 2) 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.


Featured topics

  • Background to the EU Risk Management
  • Objectives and Structure of the EU-RMP
  • Group Work on Project Management
  • Source Data and Planning Process
  • EU-RMP for Generic Medicinal Products (and other "Article 10" Products)
  • Product and Disease/Condition Overviews
  • Safety Specification Modules SII-SVI
  • Identification and Characterisation of Safety Concerns (Modules SVII and SVIII)
  • RMPs outside of the EU
  • Group Work on Safety Concerns
  • Pharmacovigilance Plan and Post-Authorisation Efficacy Studies
  • Risk Minimisation Measures
  • Summary of the EU-RMP and Annexes
  • Monitoring of the EU-RMP Quality
  • Group Work on Risk Minimisation


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 professionals involved in preparation of the EU-RMP and working within the pharmaceutical industry, service providers, and research institutions.


Learning objectives

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

  • Understand requirements of the EU Good Pharmacovigilance Practice Module V and Guidance on the format of the RMP
  • Learn the best medical writing practices for EU-RMP and consistency check with other parts of the dossier
  • Understand the project management challenges



To test your system compatibility, please click on the link:

Operating Systems

  • Windows: XP 32-bit (SP3), 2003, Vista 32-bit/64-bit, Windows 7 32-bit/64-bit
  • Mac OS X: 10.5, 10.6, 10.7
  • Linux: 32-bit Ubuntu 10.x,11.x 32-bit Fedora 15/16, 32-bit Red Hat 5/6, 32-bit OpenSuSE 11.4

Minimum System Requirement

  • Windows: Processor – Requires Sun Java 5 or higher, Recommend ActiveX be enabled for Internet Explorer
  • Mac OS X: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access
  • Linux: Processor – JavaScript and cookies enabled, Requires Apple Java 5 or higher, No support for Remote Access


  • Windows: Internet Explorer 6, 7, 8, 9, (Win7 Only), Firefox latest (32-bit), Chrome latest
  • Mac OS X: Safari 4-Mar; Firefox 2/3/3.5
  • Linux: Mozilla 1.7, Firefox 2/3/3.5

Internet Connection Speed

  • Windows: Intel or AMD processor (1GHz or faster), At least 512 MB RAM (at least 2 GB RAM for Vista)
  • Mac OS X: Intel processor, At least 512 MB RAM
  • Linux: At least 512 MB RAM


  • 800x600 pixel resolution or greater (1024x768 pixels recommended)


Contact us

Registration Questions

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+41 61 225 51 51

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+41 79 333 29 76

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