GET CERTIFIED IN DRUG SAFETY


RECOGNIZED COURSE QUALITY


DESIGNED FOR EXPERTS BY EXPERTS


RISK MANAGEMENT PLANS AND EUROPEAN UNION REGULATORY PERSPECTIVE


OBJECTIVES

This course aims to introduce the different aspects to take into account as philosophical aspects, risk perception concepts but also guidance to take into account as Risk Management Plan for European Medicines Agency, International Committee Harmonization E2E, Committee for Human Medicinal Product guidance and new legislation.

RMP, EMA, ICH E2E, CHMP guidance, Benefit Risk terminology, RA in assessing an EU RMP

 

LEARNING OUTCOMES

At the end of the course, you will gain knowledge in

  • Benefit risk terminology and concepts

  • Guidance on Risk Management Plans

  • Focus and attention of Regulatory Authorities in assessing an European Union Risk Management Plan

 

60 minutes
Online based learning
English language
Certificate of Achievement
500 €
REGISTER NOW

AUTHOR

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Dr. Sabine Straus

Dutch Medicines evaluation Board



COMPANIES OFFER

Short courses can be included in a training package for your team!


NEED TO TALK TO US?

+33 5 47 30 42 69

Monday-Friday / 9.00am-6.00pm CET

 

Supported By

IMI logo EU logo efpia logo

Created By

Eu2P Partners