Navigating eCTD Submissions in China
August 29, 2024
30 Minutes
Join the Webinar at your Convenient Time
For Americas and European Regions
10:00 AM EDT | 9:00 AM CDT | 3:00 PM BST
For Rest of The World Region
11:30 AM IST
What is it all about?
Amidst the vibrant expansion of the Chinese pharmaceutical market, many pharmaceutical organizations are seizing the opportunity to market their products within China. China eCTD is important as it standardizes the regulatory submission process, enhances efficiency, ensures data integrity, and helps companies navigate complex regulatory requirements. Noteworthy is the initiative by China's health authority, the National Medical Products Administration (NMPA), which has unveiled preliminary frameworks outlining prerequisites, technical specifications, and validation criteria for Chinese eCTD submissions. To provide input on these insights and various unanswered questions around China's eCTD requirements, Freyr brings you an informative webinar on:
The webinar will be hosted by Summer Xia and will be presented by Jane Zhang. In brief, the topics that will be discussed during the webinar include:
- 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
Given the keynotes and with due respect to your busy schedule, we really look forward to seeing you in the webinar.
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.