What is included?
2 Chapters incl. 14 E-book Sections
18 Flowcharts and Tables
35 References
1 List of Requirements for Design & Manufacture
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.
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.
1 thought on “Technical Doc.”