China currently spends $640 billion on healthcare every year, representing the most significant growth market in the world for the pharmaceutical industry. U.S. pharmaceutical companies, industry associations, and U.S. government agencies interested in learning about the Chinese approval process for foreign drugs and the postmarket monitoring process for pharmaceuticals will have the opportunity to connect with senior officials from the China National Medical Products Administration or NMPA (formally the Food & Drug Administration or CFDA) during the China NMPA Executive Leadership Training, hosted by the U.S. Trade & Development Agency (USTDA).

The Training will advance global best practices on approving imported pharmaceuticals through networking and information sharing.

Industry Workshop for U.S. Companies
11:30AM-6:00PM, Thursday, February 28, 2019
National Press Club, Washington, D.C.

TOPICS OF DISCUSSION WILL FEATURE WHY YOUR BUSINESS SHOULD ATTEND
    • Lifecycle pharmaceutical quality control
    • Post-marketing assessments: adverse events, recalls, & remedies
    • New trends in product development
    • Counterfeit pharmaceuticals and risk signals
  • Retail distribution, including pharmacies & PBMs
  • Engage senior officials from the NMPA
  • Learn the needs and goals of China’s pharmaceutical regulatory environment
  • Form new business partnerships


Workshop Schedule

11:30am – 1:00pm Lunch and Opening Remarks Carl B. Kress, Regional Director for East Asia, USTDAYuan Lin, CNMPA Delegation Leader
1:00pm – 4:00pm Workshop Theme: “How Industry and Regulators Can Work Together to Foster Innovation” Moderator TBD
1:00pm  – 1:10pm Moderator Comments Moderator TBD
1:10pm – 1:30pm Speaker 1: China NMPA Delegate China NMPA – TBD
1:30pm – 1:50pm “Role of Post-Marketing Studies in Expedited Programs” Karen Weiss, VP, Global Regulatory Policy & Intelligence, Johnson & Johnson
1:50pm – 2:00pm Coffee/Tea Break
2:00pm – 2:20pm Speaker 3: USFDA -TBD USFDA Speaker (to be determined)
2:20pm – 2:40pm “Considerations for Regulatory Use of Real World Evidence for Approval of New Products and Indications” Cathy Crichlow, PhD, Vice President, Center for Observational Research, Amgen
2:40pm – 3:00pm Speaker 5: US-China Business Council USCBC – TBD
3:00pm – 3:155pm Coffee/Tea Break
3:15pm – 4:00pm Panel Discussion – How Industry and Regulators can Work Together to Foster Innovation and Question and Answer Session Moderator + Session Speakers TBD
4:00pm – 4:10pm Wrap-up
4:10pm – 6:00pm Reception

Welcome Remarks: USTDA, Speaker TBD

HCP Rep, Speaker TBD


Delegates
The delegates from China’s National Medical Products Administration include Director level executives from Department of International Cooperation, Department of Registration, Supervision & Evaluation Department, and many more from China NMPA and affiliated agencies such as the Medical Device Test Division.

Registration is now closed. If you wish to be placed on a waitlist please contact hankk@phmintl.com.
Registration and attendance is at no cost, however registration is required and participation at and/or sponsorship of an event held in the United States is limited to U.S. Individuals, U.S. Firms or U.S. Consultants, each as defined in USTDA’s Nationality, Source and Origin Requirements (link to “Nationality Requirements“), in addition to invited delegates from USTDA eligible countries.

Sponsorship
Limited sponsorships are available for U.S. companies. For additional information please click here or contact Mr. Hank Kearney at HankK@phmintl.com.

USTDA is sponsoring the program in cooperation with:


NOTE:
The HCP site is undergoing renovation and may be down at times, in which case, please click here for a PDF file with more information on HCP.

Contact Information

PHM International is organizing this event on behalf of USTDA. For more information please contact Mr. Patrick Sharpton, international development with PHM International at PatrickS@phmintl.com or +1.571.201.0957.


Sponsored byustda_logo_vector_white U.S. Trade and Development Agency

The U.S. Trade and Development Agency helps companies create U.S. jobs through the export of U.S. goods and services for priority development projects in emerging economies. USTDA links U.S. businesses to export opportunities by funding project preparation and partnership building activities that develop sustainable infrastructure and foster economic growth in partner countries.


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