EU Pharmaceutical Regulations & Strategy

Benefits of Attending

• Understand the Legal Basis of the EU Regulatory Environment
• Discuss Development Strategy and Pre-Submission Activities
• Review Procedures for Applying for a EU Marketing Authorisation
• Discuss Post Authorisation Strategic Considerations and Obligations

This course will provide an up-to date overview of the European pharmaceutical regulatory environment, procedures and obligations. You will learn about the legal basis of regulation, development strategies and the strategic importance of pre-submission actions, the format for presentation of data, how the registration procedures work and post authorisation strategies and obligations.

It will be of value for regulatory affairs personnel and also for those who interact with regulatory personnel in order to understand action time-lines and information requirements

This course is for you, particularly if involved in:

• Regulatory affairs
• Project management
• Business planning
• Commercial Managers
• Manufacturing and QA
• Labelling and artwork
• Medical information
• Clinical
• Pharmacovigilance