Date: 19-22 December 2024
Location: Virtual
Language: English
Introduction
The 14th China International Conference on Medical Device Supervision and Management will take place in Wuhan, Hubei Province, from December 19–22, 2024, under the theme "Adhere to Innovation-Driven, Strengthen International Cooperation, and Promote High-Quality Industry Development."
The event will address international medical device innovation, regulatory challenges, cutting-edge technologies, and industry development. Topics include regulatory policies, technical rules, lifecycle quality management, and global cooperation. Featuring a plenary session and six specialized tracks, it will explore areas like clinical evaluation, post-market compliance, high-end equipment, and data security.
Participants include regulatory authorities, review and testing agencies, and experts from domestic and international organizations, fostering collaboration to advance the medical device sector.
Virtually Meet and Greet Qserve Experts for the following sessions:
- ''Implementing EU MDR in the midst of new AI, sustainability and data legislation'' hosted by Gert Bos. This session will discuss the status of MDR implementation in Europe and the influences generated by the latest guidance but, above all, by new legislation such as the AI Act, environmental sustainability policies, data protection, and the European Health Data Space. It will help the audience connect the dots between the many parts of the growing EU legal framework.
- ''How to utilize China clinical trial data for entering EU market?'' hosted by Bianca Lutters. This session will explore the different routes and best practices for repurposing clinical trial data and other real-world evidence collected in China to support medical device market access in EU. Essential solutions include using China data itself as well as building hybrid data sourcing from China and EU, both in pre-and post-market phases.
- ''Building the Foundation for Success: Clinical and Regulatory Strategy'' hosted by Minghua Chen. In the field of medical devices, a well-designed clinical and regulatory strategy is a key factor in ensuring the successful market launch and long-term success of products. These strategies must not only navigate the complex and stringent regulatory requirements of global markets but also address the uncertainties arising from the rapid advancements in medical technology and regulatory science. This presentation will analyze the key elements of clinical and regulatory strategies, as well as the core responsibilities of regulatory affairs professionals at each stage of the product lifecycle. It will explore how regulatory affairs professionals can work closely with other departments to deeply integrate clinical and regulatory strategies with product development and business objectives, thereby accelerating the product launch and market access process within a compliant framework, and eventually driving the product's success.
For more information about the event and to register, visit the event website.
Qserve Experts