Multinational Clinical Trials
of Medical Devices

Managing Director
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Director of Regulatory Affairs; Current Wenkai is Director of Regulatory Affairs at Abbvie. Prior to joining Abbvie, Wenkai was a director of International Regulatory Affairs at Medtronic Diabetes, where she was responsible for the Greater China region. While there, Wenkai led the regulatory team in implementing product registration strategies and managing regulatory submissions. She has an in-depth understanding of medical device regulations/requirements and has extensive experience in communicating with APAC regulatory authorities. From 2010-2014, Wenkai took an expat assignment to Beijing China as Director of regulatory affairs for Allergan, overseeing the development of regulatory plans and managing key regulatory timelines. She worked on-site with NMPA and obtained multiple regulatory approvals for class II devices. Before joining Allergan in 2010, Wenkai worked at Johnson and Johnson for 14 years supporting Aesthetics device products. She has extensive experience and knowledge of IDEs, clinical studies, and regulatory submissions for breast implants and dermal fillers with the FDA and other international regulatory agencies. A native of Beijing, Wenkai was educated in both China and the US. She received her Bachelor's degree in Environmental Engineering from Beijing Polytechnic University and Master degree in Analytical Chemistry from University of Utah. Currently, she is a member of the China Association for Medical Devices Industry.
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Helene Quie has a degree in Science specialised within cell biology from the University of Odense. Helene has 25 years of experience within the pharma and medical device industries working for inter alia Cook Medical A/S, H. Lundbeck A/S, AMBU A/S and Millimed A/S. Her primary expertise is within the clinical and regulatory areas such as device development, quality management, project management, clinical trial execution, market access and general management. In 2006 she founded Qmed Consulting as a private consultancy company providing services within medical device development and clinical trials.