Overview
This course provides instruction on the practical side of the approval system in the EU and how to apply the centralized mutual recognition and national registration procedures to a variety of products.
What You Will Learn
- Practical side of the EU approval system
- How to apply the centralized, mutual recognition, and national registration procedures to a variety of product types
- Current medicines legislation to ensure regulatory data protection requirements
Who Should Attend
- Clinical research associates
- Regulatory affairs
- Project management
- Administrative support
- Study support
Learning Objectives
Participants who complete this training should be able to:
- Explain the importance of the Single Market to your studies
- Use current registration filing application procedures in the EU for various product types
- Plan for common issues and integrate solutions such as trademark and patents into your studies to ensure timelines are met
- Plan for and meet new medicines legislation for your products
- Develop protocols that ensure effective clinical trials