This practical 2-day training course will examine every aspect of meeting the complex regulatory requirements associated with combination products. From early definitions of your product, through to post marketing adverse event reporting, you will learn which regulations directly apply to your product and what steps you need to take to achieve full compliance.
The two days will be divided into lectures, practical problem-solving exercises and group discussions. Delegates are encouraged to share their experiences and are invited to submit specific question prior to the course.
This course has been specifically designed to address the needs of those working in the following areas:
- Regulatory Affairs
- Compliance
- Document Management
- Project Managers in Regulatory Affairs
- Research & Development
- Business Development
