The course, a Thomson Reuters Cortellis Regulatory Online Learning module, describes the establishment of the European Union and its founding treaties, main institutions, and lawmaking process. The course outlines the different types of secondary legislation and reviews key European pharmaceutical legislation, starting from the first European directive issued in 1965. It also describes the current pharmaceutical marketing authorization procedures and the role of the regulatory authorities involved in drug application evaluation and approval. The course concludes by reviewing the structure of the European Medicines Agency (EMA) and the role each committee plays in safeguarding public health.
- EU founding treaties, main institutions, and lawmaking process
- EU pharmaceutical marketing authorization procedures and regulatory authorities
Who should attend?
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Participants who complete this course should be able to:
- Describe the establishment of the European Union and its evolution and enlargement
- Identify European Union institutions’ roles and responsibilities
- Outline the lawmaking process
- Describe the evolution of the pharmaceutical legislation since 1965
- Introduce European drug registration procedures
- Discuss the European Medicines Agency (EMA) role, function, and structure
The course takes an average of 1.5 hours to complete.