Drug registration pathways in China

1.5
RAC Credits
Virtual ProgramsVirtual Programs
Thursday, 09 March 2023 (6:00 PM) - Thursday, 09 March 2023 (7:30 PM) Eastern Time (US & Canada)

This webinar is an overview of China’s regulatory requirements for pharmaceuticals. It will review registration requirements for chemical and biological drugs, administration fees, application timelines, and offer tips for submission dossiers and approval. There will be a discussion of fast-track possibilities and accelerated timelines as well. The session will also cover the latest regulatory updates and frameworks for manufacturers seeking Chinese approval. It will explain key roadblocks and offer practical tips during an interactive section of the webinar.


REGISTRATION FEES 

9 January 2023 — 09 February 2023 Early Bird $150 member | $175 nonmember

10 February 2023- 09 March 2023: Regular $175 member | $200 nonmember


Learning Objectives

At the conclusion of this workshop, participants should be able to:

  • Describe how to win Chinese approval for chemical and biological drugs

  • Audience Learning Level

    Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.


    Who Should Attend?

    Regulatory professionals and manufacturers.


    Instructors:

    Hamish King

    Hamish King

    Hamish King is COO at Cisema, a regulatory consultancy with offices in Munich and Beijing. A lawyer by training—barred in Hong Kong and New South Wales, Australia—King previously worked with UK "magic circle" firm Linklaters in Hong Kong. King holds both RAC and CFA qualifications. King regularly pens articles and speaks about the regulation and approval process for life-sciences products in China. King lives in Hong Kong and can be reached at hamish.king@cisema.com.


    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.  RAPS is unable to accept cancellations by phone.

    To transfer a registration, email raps@raps.org with the event title, name of the original registrant, and contact information for the new attendee.


    Proof of Attendance

    A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.

     

    Questions

    For additional hands-on support, you can also connect with RAPS support 30 min prior to the workshophttps://www.raps.org/website/virtual-event-help

    For account support, contact the RAPS Support Center: at +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org.

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