China has been dedicated to drug registration reform to standardize and optimize the approval procedures and integrate with international regulations since China joined ICH in 2017. Over the past years, China has introduced urgently needed drug inventory lists and accelerated review pathways system, as well as certain special pathways to expedite the registration process for breakthrough therapy drugs, pediatric drugs, orphan drugs, and other urgently needed drugs.
This workshop will introduce China’s registration and accelerated pathways. In addition, we will also share hands-on tips to help develop registration strategies of quicker market access to China through these policies as well as best practices for China Drug Master File (DMF).
Registration Fees & Deadlines
5 November 2023– 16 March 2024: Member $150 | Nonmember $175
16 March 2024 – 16 April 2024: Member $175 | Nonmember $200
Learning Objectives
- Upon completion of this session, participants should be able to describe what kinds of drugs are eligible to apply for accelerated review or special pathways in China.
- Upon completion of this session, participants should be able to explain how to develop a registration strategy based on the product features and company resources in China.
- Upon completion of this session, participants should be able to avoid the most common pitfalls when preparing and applying for drug registration in China.
- Understanding China drug master file (DMF) and how to be submission ready.
Who Should Attend?
Anyone involved and interested in drug registration and DMF, including pharmaceutical physicians and those working in:
- RA department
- QA/QC
- R&D, clinical research
- Regulatory affairs
- Registration
- International BD/ marketing/ purchase
- Legal affairs
- Auditor
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.
Speakers
Helen Ye
Accestra Consulting, Regulatory Affairs Director
April Wang
Accestra Consulting, Regulatory Affairs Manager
Cancellations and Refunds
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 support@raps.org. Cancellations will receive a full refund minus a 20% administrative fee. RAPS is unable to accept cancellations by phone.
Substitutions
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 support@raps.org with the event title, name of the original registrant and the 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
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email
RAPS@raps.org