Navigating eCTD Submissions in China
Topics Covered:
We are delighted to see your interest in Freyr’s Webinar Series. The webinar on “Navigating eCTD Submissions in China” was successfully concluded on August 29, 2024. Here is the archived session for your perusal.
In a nutshell, our presenter, Ms. Jane Zhang, discussed the following topics:
- The Evolving Regulatory Landscape for eCTD Submissions in China
- How to Comply with China's eCTD Requirements
- The Benefits of Using eCTD for Submissions to China
- Tips for Navigating eCTD Submissions in China
As a continuous practice, Freyr intends to organize more webinar sessions related to the Regulatory aspects of Life Sciences. We believe that you would like to be a part of all those sessions. If yes, we will be happy to inform you in advance about our next session.
Summer is an Associate Director- Medical Devices, Freyr China. With over 20 years of experience, including fifteen (15) years in medical device regulatory affairs, Summer has excelled in navigating both pre-market and post-market requirements. Her expertise has been instrumental in guiding numerous foreign and local manufacturing companies entering the Chinese market. Summer’s leadership has been demonstrated through her roles heading multinational Quality Assurance and Regulatory Affairs teams. She holds an MBA and is a certified Lead Auditor by BSI, enabling her to proficiently manage complex compliance landscapes.
Jane, a seasoned Senior Director of Regulatory Affairs, Freyr China expert has over seventeen (17+) years of experience in new drug R&D and more than twenty (20+) years of experience in Regulatory Affairs (RA).
She possesses a deep understanding of NMPA and global regulations, including FDA, EU, and ICH. Her strong scientific background, extensive knowledge, and previous role as a CDE reviewer contribute to her comprehensive understanding and interpretation of these regulations.