China’s new medical device regulations went into effect 1 October 2014. This session will review the impact of the new regulations to date and focus specifically on challenges around clinical trials in China and new guidance’s issued about the execution of clinical trials and opportunities to avoid them.
Learning Level(s): Intermediate
Upon the webcast's conclusion, you will:
- Understand China’s new medical device regulations and their impact on foreign device manufacturers
- Discuss the potential to avoid clinical trials: China’s Clinical Evaluation Report
- Describe best practices for executing clinical trials in China
Who Should Attend
- Regulatory Affairs
- Clinical Affairs
- Business Development
Cindy Hu, director of regulatory, NAMSA China
Cindy Hu, director of regulatory for NAMSA China has more than 10 years of experiences in China's medical device industry. In 2013 alone, she led her team to 39 successful CFDA registrations and has overseen hundreds through her career. Hu has most recently worked in Stryker China as manager of RA/QA. In addition to CFDA expertise, she also has successfully guided companies through Quality Management Systems (QMS) audits with FDA and audits from EU notified bodies.
Seth J. Goldenberg, PhD, director of global regulatory strategy, NAMSA
Seth J. Goldenberg, PhD, is currently the director of global regulatory strategy with NAMSA and a former member of the US Food and Drug Administration. At NAMSA, Goldenberg works with over 750 NAMSA associates to develop global strategies for success taking into account regulatory, clinical, testing and business considerations around the world. He understands not only what it takes to carry out scientific study, but also the importance of communicating it with the global scientific community to foster partnerships and collaboration, demonstrated by his strong publication record in such journals as Cell, Science, and Nature Cell Biology that have been cited over 900 times. Goldenberg holds a PhD in Pharmacology from the University of Washington and a MS from the School of Biomedical Engineering at Drexel University.
Barbara Atzenhoefer Stegmeier, medical research manager – regulatory, NAMSA
Barbara Atzenhoefer Stegmeier has more than 20 years of experience in the medical device industry and served in regulatory, quality and clinical functions in both large medical device companies and start-up companies before joining NAMSA. Her areas of clinical expertise, include but are not limited to cardiovascular, orthopedic and ophthalmic devices. Atzenhoefer Stegmeier has experience with all types of medical device clinical and marketing applications for the US, Canada, EU and many other countries.