The EU unifies more than 27 countries, 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. High standards of quality, safety and efficacy have to be met in order to obtain a marketing authorization (MA). The European Medicines Agency (EMA) is a decentralized organization, which provides a central procedure for accessing the EU market, while the individual Member States share responsibilities and provide resources for the assessment of applications and compliance monitoring.
This course provides an overview of the regulations and legislative framework, as well as the EMA entities pertaining to pharmaceuticals and review. The different application and registration procedures will be described, followed by an explanation of the regulatory requirements for a product’s lifecycle, including marketing and postmarketing requirements, and the switch to over-the-counter (OTC). The enforcement of regulations through inspections and other compliance activities will also be addressed. This course explores critical concepts required for regulatory professionals to advance their careers and professional development.
Learning Objectives
Upon completion of this course, participants should be able to:
- Outline EMA’s framework and identify key contact points
- Recognize and discuss the unique elements of the European regulatory directives
- Describe the pharmaceutical legislative framework as well as associated regulations, including Good Manufacturing Practice (GMPs), clinical trials directive, Competent Authority inspection and Mutual Recognition Agreements (MRAs)
- Explain the medicinal products registration procedures—Centralised Procedure (CP), Mutual Recognition Procedure (MRP) and Decentralised Procedure (DCP)
- Understand EMA’s Scientific Advice procedures
- Define and describe advertising and promotion regulations for medicinal products
- Outline key EU postmarketing activities, including requirements for postmarketing surveillance
- Identify and explain types of enforcement activities for medicinal product regulations
Target Audience
This course is beneficial for regulatory and quality assurance professionals seeking to learn the basics of European pharmaceutical law, regulations and their implementation into national laws in the individual EU Member States.