Online CourseOnline Course Pharmaceutical Certificate ElectivePharmaceutical Certificate Elective

Pharmaceuticals: EU Regulations [6.0 RAC]

6.0 RAC Credits Member: $570.00 Nonmember: $790.00
Pharmaceuticals: EU Regulations [6.0 RAC]
The European Union (EU) unifies 28 Member States as well as countries in the European Economic Area (EEA), providing a single market for the pharmaceutical industry. The EU’s directives and regulations outline the requirements for the development, manufacture and marketing of medicinal products for human and veterinary use. These requirements are distinct from those for development and authorisation of medical devices and in vitro diagnostics in the EU. High standards of quality, safety and efficacy have to be met in order for a product to be granted a Marketing Authorisation (MA). The European Medicines Agency (EMA) is a decentralised organisation responsible for the scientific evaluation of EU Marketing Authorisation Applications for human and veterinary medicines through the Centralised Procedure. Within individual Member States, designated Competent Authorities assess marketing applications and monitor compliance for medicinal products submitted under the Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and National Procedure (NP).

This course provides an overview of the regulations and legislative framework, as well as the EMA entities responsible for medicinal product reviews. The different application and registration procedures are described, followed by an explanation of the regulatory requirements for a product’s lifecycle, including marketing and postmarketing requirements, and prescription to over-the-counter (OTC) switches. The enforcement of regulations through inspections and other compliance activities is also addressed.

At a Glance
  • Target Audience: This course is beneficial for regulatory and quality assurance professionals seeking to learn the basics of EU pharmaceutical law and regulations and their implementation into national laws in the individual EU Member States.
  • Learning Level: Basic
  • Total Length of Course: 6 Hours
  • RAC Points: 6

Learning Objectives

Upon completion of this course, participants should be able to:
  • Outline the EMA framework and identify key players for pharmaceutical development and registration
  • Describe the unique elements of the EU directives and regulations
  • Describe the medicinal product legislative framework as well as associated regulations, including Good Manufacturing Practices (GMPs), Good Distribution Practices (GDPs), Good Pharmacovigilance Practices (GVPs), clinical trials directive, Competent Authority inspections and Mutual Recognition Agreements (MRAs)
  • Explain the medicinal products registration procedures—Centralised Procedure (CP), Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and National Procedure (NP)
  • Identify EMA’s Scientific Advice procedures
  • Define and describe advertising and promotion regulations for medicinal products
  • Outline key EU postmarketing activities, including requirements for postmarket surveillance
  • Explain types of enforcement activities for medicinal product regulations

Lesson Titles
  • Lesson 1: Overview of the EU Regulatory Framework
  • Lesson 2: Pharmaceutical Regulation and Legislation
  • Lesson 3: Medicinal Products Registration Procedures
  • Lesson 4: Over-the-Counter (OTC) Products
  • Lesson 5: Advertising and Promotion of Medicinal Products
  • Lesson 6: Postmarketing Activities
  • Lesson 7: Pharmacovigilance
  • Lesson 8: Enforcement of Medicinal Product Regulations

Enrollment Period: 12 months
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