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)

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