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