Introduction to Regulatory Affairs in the EU

This course focuses on the development of healthcare product regulation in the EU. It discusses the responsibilities of agencies involved, processes employed and interactions among agencies. 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 Authorization for a medicinal product—Centralised Procedure, Decentralised Procedure, Mutual Recognition Procedure and the 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
  • Learning Objectives
  • Lesson Titles
  • Registration Options

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: 1–2 Hours
  • RAC Credits: 1
  • Cost: Member $135; List $185
  • Format: PC and Tablet (iPad and Android)
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Learning Objectives

Upon completion of this course, participants should be able to:

  • 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

  • Lesson 1: Regulatory Framework
  • Lesson 2: Regulated Products and Processes

Registration Options

This course is available for purchase as follows: