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The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
Share your knowledge and expertise with your regulatory peers by submitting an in-depth, evidence-based article focusing on key areas and emerging issues in the global regulatory landscape.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
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Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
RAPS Euro Convergence brings regulatory peers from the EU and worldwide together in one forum to gain insights and exchange ideas on the region's most pressing issues. Register today to attend 10-12 May 2021.
Registration is now open for RAPS Convergence 2021! Gather with the regulatory community 12-15 September for four days of learning, engagement, and excitement.
This brand-new publication offers a guide through the complex landscape of regulations, standards, and interpretations surrounding software as a medical device.
Regipedia is an interactive resource created to benefit RAPS members with 24/7 access to more than 2,300 regulatory terms.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
This workshop will cover different clinical evaluation and pathways and how to decide which pathway to choose to support China NMPA medical device/IVD regulatory approval or post market study requirements. With the release of “Regulation on the Supervision and Administration of Medical Devices”, Order 739 from the State Council, China NMPA is encouraging more versatile clinical evidence to support clinical evaluation to simplify the China NMPA regulatory approval process.
In addition to the traditional clinical evaluation report/clinical trial, we will go in-depth on the latest requirements for overseas clinical data acceptance and real-world data/study to mitigate the redundancy of clinical trial burden. Key considerations on the feasibility and gap justification of overseas clinical data acceptance will be discussed, especially the ethnic difference considerations.
Finally, attendees will learn about the emerging use of Real-World Data (RWD), other clinical evaluation alternatives such as CER, geographic special policies of real-world study –a faster alternative to the traditional clinical trial. Overseas manufacturers can obtain approval for the RWD pilot program through the Hainan provincial NMPA to start using devices in clinical settings prior to national NMPA approval, cutting years down to to months for the initial clinical use.
Don’t miss out on the opportunity to learn more about this new policy and the versatile clinical evidence updates from Order 739!
31 March 2021 - 27 April 2021: Early Bird $480 Member | $540 Nonmember
28 April 2021 - 26 May 2021: Regular $540 Member | $600 Nonmember
Grace Fu Palma has more than 20 years of medical technology and diagnostic industry experience. She is the CEO of China Med Device, providing turnkey solutions for western medical device/IVD/CDx products companies entering China. The company has processed more than 1,000 China National Medical Products Administration (NMPA) certificates, and accelerated more than 250 companies’ success. A seasoned bilingual and bicultural MedTech executive, Fu Palma has held a variety of marketing, operational and strategic development management positions at both large multinationals and startup companies. She specializes in China NMPA and commercialization services. She grew up in Beijing, and has a bachelor’s degree from Peking University, China, and an MBA from Yale University.
Yan Sheng grew up in China and has years of experience working in the life science industry in both the US and China, and has more than eight years of experience as a project manager at a CRO. She has experience with drug development companies in both the US and China such as Alfa Chemistry Inc. in the US, and Hangzhou Huadong Medicine Group Co. Ltd. in China. Sheng has six years of experience in the academic field working with cutting edge technologies in both chemistry and microbiology, and has extensive research expertise in natural products chemistry, molecular biology and microbiology, genetic manipulation, protein expression and purification, and in vitro enzymatic reactions. Sheng has been published in a number of academic journals and has a PhD in pharmaceutical sciences.
Mingdong Zhang is chief medical officer and vice president of medical affairs for Boston Scientific Asia Pacific. Previously, he served as chief medical officer and vice president of medical and regulatory affairs for Boston Scientific Greater China. Prior to joining Boston Scientific, Mingdong served as global medical director for Johnson & Johnson’s electrophysiology business in Southern California for more than four years, and as a medical officer/epidemiologist at US FDA’s Center for Devices and Radiological Health (CDRH). He also spent eight years conducting academic and clinical research at the US National Institutes of Health as a research fellow and staff scientist, and at the medical school of the Chinese University of Hong Kong as a professor. Mingdong graduated from Shanghai Medical University with a MD and MPH in epidemiology. He earned his PhD in molecular virology from Baylor College of Medicine.
Dr. Xiaoguang Ma works as an associate regulatory affairs director for Medtronic Greater China and leads a team providing expertise and guidance on registration strategy, clinical evaluation, and epidemiological and biostatistical methods. He currently serves as the chair of the Clinical Evaluation Task Force at COCIR, European trade association for the medical imaging, radiotherapy, health ICT and electromedical industries. Ma has worked in the healthcare system with both academia and industry for more than 14 years. Before joining Medtronic, he was an associate professor at Zhejiang University School of Public Health, and published more than 30 scientific papers and co-authored or editied several textbooks. He received his MD from Peking University, MPhil in public health from the University of Hong Kong, and PhD in epidemiology and biostatistics from the University of South Carolina.
Qianqian Zhu has more than eight years of experience working on China NMPA registration, covering type test and clinical trials, and has obtained more than 20 approvals of Class III medical devices, IVDs and drugs in China. Zhu is an expert on China CER and PRER technical writing. She has worked with China’s Center for Medical Device Evaluation (CMDE) on the drafting and release of five technical review guidance documents. Zhu also worked with the Beijing Institute of Medical Device Testing (BIMT) and the National Institutes for Food and Drug Control (NIFDC) on national standards development. She practiced law and worked on international trade in China and the UAE prior to coming to the US, and she has the RAC (Global).
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and the event title. Substitutions may be accepted with written approval from RAPS and must be submitted to raps@raps.org.
Following the virtual event, please complete the evaluation survey located in the RAPS Learning Portal. Attendees will then have immediate access to their Certificate of Attendance.
Call RAPS Solutions Center at +1 301.770.2920, Ext 200 or email raps@raps.org.