China Drug Registration and Reimbursement

This workshop will outline the main steps for drug registration in China. Topics include: drug classification, getting Clinical Trial Applications (CTA), using overseas clinical data, registration steps, length of registration process, expedited review, API registration, excipients and orphan drugs, and best registration pathways; reimbursement topics include obtaining National Medicine listing (NEML), obtaining National Reimbursement Drug listing (NRDL), Volume-Based Procurement (VBP), and best market-access strategies.

Registration Fees & Deadlines

January 19, 2023 — April 16, 2023: Early Bird $150 Member | $175 Nonmember
April 17, 2023 – May 16, 2023: Regular $175 Member | $200 Nonmember

Audience Learning Level

Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.

Who Should Attend?

International and domestic regulatory affairs executives, market access or reimbursement executives, business development executives, anyone interested in succeeding in China.

Speakers:

Ames Gross
President and Founder, Pacific Bridge Medical

Ames Gross founded Pacific Bridge Medical in 1988 and has helped hundreds of medical companies with Asian business development and regulatory issues. He is recognized nationally and internationally as an Asian-market expert. In 2008, “Medical Device and Diagnostic Industry” magazine named Gross one of the top 100 executives in the medical business. He is a frequent contributor of articles on Asian medical issues for that publication and other medically oriented journals. He has been a featured speaker on the Asian medical markets at medical design and manufacturing shows, the Medtrade Home Health Care Exhibition, RAPS Convergence, and a variety of other medically oriented meetings and conferences. Gross is a University of Pennsylvania Phi Beta Kappa and holds an MBA from Columbia University.

Cancellations

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 to raps@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email raps@raps.org with the event title, name of the original registrant and the contact information for the new attendee.

Proof of Attendance