Overview of EU (European Union) and UK Regulatory Affairs

Overview of EU (European Union) and UK Regulatory Affairs is a course that provides an introduction to pharmaceutical regulatory affairs, offering participants practical knowledge of EU and UK legislation, regulatory procedures, and post-authorisation requirements.

Key Topics

• EU legislation and proposed revisions
• Common Technical Document structure
• Post-authorisation obligations including pharmacovigilance, variations and renewals
• Procedures for marketing authorisation in the EU and UK
• Case studies and practical applications in regulatory affairs
• Regulatory strategy updates and continuing professional development

Who should Attend

• Assistants and administrators in regulatory roles
• Personnel new to regulatory affairs
• Individuals considering a role in regulatory affairs
• Staff supporting or interacting with regulatory affairs functions