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Introduction to Regulatory Affairs in the EU [1.0 RAC]

1.0 RAC Credits Member: $135.00 Nonmember: $185.00
Introduction to Regulatory Affairs in the EU [1.0 RAC]
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

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

Enrollment Period: 12 months
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