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Virtual Event

2023年9月26日 (火) 午前 9:00 - 2023年9月28日 (木) 午後 1:00

(Central Europe Standard Time)

4051 Basel, Switzerland

Risk Management Plan (EU-RMP) Creation

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

概要

This hands-on virtual live training 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.

 

特集トピック

  • Background to the EU Risk Management
  • Objectives and Structure of the EU-RMP
  • RMP publication on EMA website – drafting early for post-opinion steps; Applicant/MAH requirements for publication
  • Identification and Characterisation of Safety Concerns (Modules SVII and SVIII)
    • Group Work on Safety Concerns
  • Risk Minimisation Measures
    • Group Work on Risk Minimisation
  • Source Data and Planning Process
    • Group Work on Project Management
  • Product and Disease/Condition Overviews
  • Safety Specification Modules SII-SVI
  • Pharmacovigilance Plan and Post-Authorisation Efficacy Studies
  • RMPs outside of the EU
  • Summary of the EU-RMP and Annexes
  • EU-RMP for Generic Medicinal Products (and other “Article 10” Products)

 

参加対象

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.

 

学習目的

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

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

 

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