Evolving Challenges of FDA & CFDA: Multilateral Collaboration for the Industry & Regulatory Stakehol (ACRP-CAP annual education symposium)

Organization: Association of Clinical Research Professionals China and Asia Pacific Chapter

Venue: Sheraton Hotel

Location: Hong Kong, Hong Kong, Hong Kong

Event Date/Time: Nov 08, 2014 / 9:00 am - (GMT +8:00 hours) End Date/Time: Nov 08, 2014 / 4:00 pm - (GMT +8:00 hours)
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Description

Quality of clinical trials is deemed paramount by the regulatory agencies for the protection and welfare of human subjects and patients. As more global trials have moved from the West to the East, especially to China, CFDA as well as the FDA have geared up their monitoring and regulatory effort. FDA, CFDA/CDE and industry experts will share their point of view about the evolving research landscape, GCP, risk-based monitoring, and the current regulatory practices in Asia.  Risk-Based Monitoring strategies use reduced source data verification (SDV), the afternoon presentations will review statistic analyses pertinent to ethics, litigation, and regulatory issues.  What is the impact of GCP on medical product review and approval?  FDA field investigator will talk about enforcement and responses to 483, and premarketing applications.  Regulatory Hot Topic Series: - The FDA guidance on mobile apps in medical applications, and the practical considerations for the developers and manufacturers of electronic medical product and health monitoring device. - The regulatory issues in Chinese Medicine.

Venue

20 Nathan Rd, Kowloon, Hong Kong
Hong Kong
Hong Kong
Hong Kong
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Organizations

Association of Clinical Research Professionals China and Asia Pacific Chapter
Hong Kong
Hong Kong

Conference Speakers

  Chair: Shaoyu CHEN, LLB, JD Partner; Managing Director China Food and Drug Practice Covington & Burling LLP, Beijing Chief Compliance Counsel, GE Healthcare China (2010-2011), Beijing, China Senior Counsel, Amgen (2006-2010), Thousand Oaks, California Assistant Chief Counsel, U.S. Food and Drug Administration (2000-2004), Maryland Bio: http://www.cov.com/schen    Dr. Qinyong Dai Medical Director, Roche Hong Kong Limited   Wendy Yan, MD, MBA Senior Vice President, Head of Regulatory Affairs, BeiGene (Beijing) Co., Ltd. Global Regulatory Strategist, Regulatory Affairs Director for China (2008-2014), Bayer  China Initiatives of the US FDA   Francis Eng Assistant Director FDA China Office, Shanghai   Chair, Prof Benny Zee, Assistant Dean (Research), Professor/Head, Division of  Biostatistics, Director, Centre for Clinical Research & Biostatistics, Faculty of Medicine,  Chinese University of Hong Kong   Dr. C K Kwan, MB, ChB, FRCR, FHKCR, FHKAM, CPI, MPM, Specialist  in Clinical Oncology, Queen Elizabeth Hospital, Hong Kong