OBJECTIVES

The objective of this module is to provide you knowledge and understanding of the concepts and principles in pharmacovigilance globally with a focus in North America such as :

1. The different qualitative frameworks and basic quantitative methods for Benefit-Risk assessment, including their potentials and limitations.
2. Insight in the changing health care environment and gives an overview of the different stakeholders that are involved in pharmacotherapeutic decision-making. Specific attention is given to the drivers and background of the different stakeholders and the rationale of benefit/risk and pharmacoeconomic evaluations in decision-making
3. An overview and to define the concepts necessary to built a risk management plan for medicinal product.
4. Define the general principles needed to build a process for developing Risk Management Plans for a medicinal product by the Industry. This course is based on the experience of a large international pharmaceutical company.
5. An introduction to REMS principles, content, implementation, reporting and assessment, When a REMS is required and the Differences between REMS and RMP

qualitative frameworks, quantitative methods, BR assessment, HC environnement, decision-making, RMP, REMS, FDA, Risk Management Plans, Benefit/risk, decision-making

MODULE PARTS

1. Benefit-risk assessment of medicines
2. Risk Management

TRAINER TEAM

Coordinator: Dr Veronique Kugener (from Takeda)

Expert(s): Dr Katia Verhamme (from Erasmus Universitair Medisch Centrum), Prof Olaf Klungel, Prof Hubert Leufkens (from Universiteit Utrecht), Dr George Quartey (from F. Hoffmann-La Roche Ltd), Dr Laurent Auclert (from Sanofi-aventis Recherche et Développement), Prof Annalisa Capuano (from Università degli Studi della Campania Luigi Vanvitelli), Dr John Price (Independent), Nasop Experts Group (from ISoP's North American chapter), (from Takeda).