EU Legal Basis

Training

What is included?

4 Chapters
13 Flowcharts & Tables
2 Assignments incl. Instructions
25 E-book Sections
20 References
1 Exam incl. Certificate

Purpose, Values + Vision

After completing this course you will be able to make good regulatory decisions with confidence and resolve common regulatory problems.

Course Attendances

This course is designed for those new to European Regulatory Affairs, as well as regulatory professionals who want to refresh their knowledge to keep up with the new European Medical Device Regulation.

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MEET THE INSTRUCTOR

Zhenrong Yu; M.D; Ph.D

Dr. Yu brings over 15 years of experience in the life science industry specialising in the regulated pharmaceutical and medical device markets. Dr. Yu possesses a strong background in defining regulatory strategies, leading quality system programs and implementing changes to related policies, procedures and systems.

Prior to founding HengRy, Dr. Yu was Vice President and executive member of the board, representing Regulatory Affairs and Quality Management for Schiller Group companies. In her earlier career she served as Regulatory Affairs Manager for Advanced Bionics, a group company of Sovona and for CSL Behring. 

Dr. Yu received her MD and PhD degrees from the University of Bern, Switzerland.

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