Offline (EN) | Healthcare Roundtable with FDA

欢迎参加 12 月 11日下午与美国食品药品管理局 (FDA) 团队的圆桌讨论。我们很荣幸邀请到 FDA全球政策与战略办公室主任约翰 "巴尔" · 韦纳博士分享有关中美之间药品、器械和生物制品监管以及相关创新和竞争的见解。FDA驻华办官员也将在会上介绍中美在医疗监管事务方面的交流与合作,包括最近的会议、项目和对外交流。


所有 HCP 成员均可免费参加!请参与本次圆桌讨论会的企业提前准备好贵司在监管领域的诉求或者感兴趣的政策话题,以便于更高效地开展线下交流。


活动信息

  • 会议形式: 仅线下,中国美国商会,华盛顿会议室
  • 时间地点:12月11日,星期三,下午13:30-15:00
  • 语言:英文
  • 联系人:Xi Wang, xwang@amchamchina.org


Join us on the afternoon of December 11 for a roundtable discussion with the U.S. Food and Drug Administration (FDA) team. We're horned to have John "Barr" Weiner, Director of the Office of Global Policy and Strategy of the FDA to share insights on drugs, devices, and biological products regulation and related innovation and competition issues. Officials from the China Office of the FDA will also update US-China cooperation on healthcare regulatory affairs, including recent dialogues, programs, and exchanges.


All HCP members are free to join! Please come prepared with the questions about your company's Regulatory Affairs issues for a face-to-face discussion.


Event Details

  • Event format: Offline, AmCham China, Washington Meeting Room
  • Time & Date: December 11th, Wednesday, afternoon, 13:30---15:00
  • Language: English
  • Contact: Xi Wang, xwang@amchamchina.org

Agenda

1:30 PM - 1:45 PM
Opening Remarks (AmCham China & FDA)
1:45 PM - 2:00 PM
Sharing from AmCham China: What we have done to support member companies in Healthcare Regulatory Affairs
2:00 PM - 2:15 PM
Sharing from FDA: Insights on drugs, devices, and biological products regulation and related innovation and competition issues
2:15 PM - 3:00 PM
Open Discussions

Speakers

  • John “Barr” Weiner (Director, Office of Global Operations, Office of Global Policy and Strategy at U.S. Food and Drug Administration (FDA))

    John “Barr” Weiner

    Director, Office of Global Operations, Office of Global Policy and Strategy at U.S. Food and Drug Administration (FDA)

    John “Barr” Weiner, J.D., is the Director of OGPS’ Office of Global Operations (OGO), overseeing the FDA’s foreign offices located in strategic locations across the globe, and the international policy advisors, regional experts, and global operations and program support staff located at FDA headquarters.

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  • Scott C. Gonzalez (FDA International Relations Specialist - Medical Devices, China Office at U.S. Food and Drug Administration (FDA))

    Scott C. Gonzalez

    FDA International Relations Specialist - Medical Devices, China Office at U.S. Food and Drug Administration (FDA)

    During his tenure at the FDA he has also served as a pre-market/post-market Lead Reviewer and Acting Chief of the Diagnostic X-Ray Systems Branch as well as a Senior Technical Advisor to the Office of In Vitro Diagnostics and Radiological Health. Mr. Gonzalez is a subject matter expert regarding the regulation of electronic product radiation emitting devices and is a contributor to many international consensus standards relating to the testing as well as the basic safety and essential performance of diagnostic x-ray systems and their major components. Mr. Gonzalez has developed and presented training to FDA inspectors performing domestic and international inspections of medical device manufacturers.

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  • Claire Ma (Vice President at AmCham China)

    Claire Ma

    Vice President at AmCham China

    Claire is the lead for AmCham China’s government affairs and policies, committees, China-US cooperation projects and signature annual events.

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  • Sarah McMullen (FDA Country Director, China of U.S. Food and Drug Administration (FDA))

    Sarah McMullen

    FDA Country Director, China of U.S. Food and Drug Administration (FDA)

    Dr. Sarah McMullen is the Country Director for the FDA China Office. As Country Director, Sarah is the lead representative for FDA in China and oversees work related to FDA’s inspections, engagement with regulatory counterparts and capacity building across regulated commodities in China. Her professional experience has included analytical method development and testing for multiple FDA-regulated commodities, establishment inspections, import operations and policy, and foreign office service. Her FDA career has spanned over 22 years working as a chemist, tissue residue specialist, consumer safety officer, and leader. The last 11 years of her experience has focused on international arenas including import operations and foreign office service.

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  • Marcus Ray (Medical Product Supervisory Consumer Safety Officer, China Office, FDA at U.S. Food and Drug Administration (FDA))

    Marcus Ray

    Medical Product Supervisory Consumer Safety Officer, China Office, FDA at U.S. Food and Drug Administration (FDA)

    Marcus Ray joined FDA in 2014 and currently serves as an Assistant Country Director with FDA’s Office of Global Policy and Strategy (OGPS), Beijing China Office. Mr. Ray has experience in conducting both domestic (US) and foreign pharmaceutical inspections. Prior to joining FDA’s Beijing Office, Mr. Ray performed pharmaceutical inspections for the Office of Regulatory Affairs (ORA), serving as a member of the Dedicated Foreign Drug Cadre. Mr. Ray earned a Bachelor of Science (B.S.) degree in Biology (Micro) from Hampton University and Master of Public Health (MPH) degree from Liberty University.

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Venue

AmCham China Washington Room

3F, East Gate 1, Pacific Century Place, 2A Workers' Stadium North Road
北京市朝阳区工体北路甲2号盈科中心东一门3层。

Beijing, Chaoyang District, China

If you have any questions please contact Xi Wang

Contact Organizer

13681124749

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