Introduction to Regulatory Affairs in the EU

This course focuses on the development of healthcare product regulation in the European Union (EU). It discusses the responsibilities of agencies involved, processes employed and interactions among agencies.

In addition, this course provides a basic understanding of the regulatory requirements to obtaining marketing approval for healthcare products. It covers the different procedures for granting Marketing Authorisation for a medicinal product:

Centralised Procedure

Decentralised Procedure

Mutual Recognition Procedure

National Procedure

Also covered is the process for medical device approvals performed by Notified Bodies (NBs)—independent third parties notified to the European Commission (EC) by the national Competent Authorities (CAs) of the Member States—who carry out the Conformity Assessment Procedures (CAPs) for medical devices.

At a Glance

Target Audience: This course is intended for those new to the regulatory profession or transitioning from a related field, including those employed by healthcare product companies, government regulatory agencies, consulting or law firms and academic research centers.

Learning Level: Basic

Total Length of Course: 1 Hours

RAC Points: 1

Medical Device Certificate Elective

Pharmaceutical Certificate Elective

Enrollment Period: 12 months

Learning Objectives

Describe the origins of the EU regulatory system

Identify the organizations involved in the EU regulatory system

Outline the regulatory processes associated with various healthcare products in the EU

Distinguish between EU processes for region-wide approval and country-specific approval

Lesson Titles