Menu Back toRisk Management Plan (EU-RMP) Creation Virtual Live Training Course

Risk Management Plan (EU-RMP) Creation Virtual Live Training Course

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


Overview

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
  • Deal with uncertainties and gaps in the data sets

 


TECHNICAL REQUIREMENTS

To test your system compatibility, please click on the link: https://diaglobal.zoom.us/test

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

Browsers

  • 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

Display

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

 

Contact us



Registration Questions

Send Email
+41 61 225 51 51


Agenda and Logistics

Send Email
+41 79 333 29 76