During this course you will learn the role and responsibilities of Pharmacovigilance Risk Assessment Committee (PRAC), Committee for Medicinal Products for Human Use (CHMP) and Coordination Group for Mutual Recognition and Decentralised Procedures — Human (CMDh). You will study their impact on the pharmacovigilance activities performed by marketing authorization holders.

The course is divided in to 5 units. To each unit one learning outcome is assigned, which focuses on discussing a specific issue.

You will learn the role and responsibilities of the Pharmacovigilance Risk Assessment Committee and its role in assessing the aspects of risk management of human medicinal products. You will learn the role and responsibilities of the Committee for Medicinal Products for Human Use which plays a vital role in the authorisation of medicines in the EU. Last but not least you will learn about the Coordination Group for Mutual Recognition and Decentralised Procedures which was establishes for examination of any question relating to a marketing authorisation of a medicinal product in two or more Member States. Moreover you will study the division of responsibilities between CHMP, PRAC and CMDh concerning pharmacovigilance decisions making process. Finally you will also learn how safety decisions are implemented at European level.