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  • WEBINARS/eLEARNING
    • Live Courses/Webinars
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HomeResearch & DevelopmentRegulatory Affairs in China – The New Drug Regulatory Framework

Regulatory Affairs in China – The New Drug Regulatory Framework

Teachers
Michael Zhang
Katrin Rupalla
Category:
Clinical Trials (GCP Training)/ On-Demand Courses/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90-Minutes
On-Demand
Includes Bonus Handouts!
  • Description
  • Who Should Attend
  • What To Expect

Description

COURSE DESCRIPTION

OVERVIEW

In August 2019, the Revised Drug Administration Law (DAL) was published by the Chinese State Council (effective from Jan 2020) followed by the release of the new Drug Registration Regulation (DRR) in January 2020 (effective from Jul 2020). These two publications are milestones in the fundamental changes that have taken place in China since August 2015, with the initiation of deeper reform of drug development and approval polices. They provide the framework for all new drug development and drug registration in China. 

This session will introduce the official institutions governing drug development and registration in China and a detailed overview of the requirements laid out in the revised DAL and new DRR for the development of pharmaceutical products. Content will provide you with best practices for approaching the new regulatory environment, as well as critical points where the landscape has changed. Additionally, you will Learn from recent case studies on potential regulatory pathways leading to new imported and local drug registration in China.

LEARNING OBJECTIVES

At the completion of this session, you will be able to:

  • Summarize the legal framework and government institutions involved in drug development and new drug registration in China
  • Interpret requirements laid out in the DAL and DRR for conducting drug development in China 
  • Identify requirements and process for registration of imported and local drug registration in China

Who Should Attend

WHO SHOULD ATTEND

This course will be of benefit any company personal involved in planning and execution of drug development and drug registration in China.

What To Expect

WHAT TO EXPECT

HOW TO PARTICIPATE

This webinar is offered on-demand. With your course purchase, you may view the previously recorded live session at your convenience (available for 30 days). Access to the on-demand webinar will be made available via email within 1 business day after your purchase. To access the course, you need only a computer with internet access and the log-in credentials.

THE TRAINING PLATFORM

Our webinar platform combines the convenience of online training with the live interactivity of the classroom. Quizzes, case studies, break-out sessions, and assessments are often incorporated into the training . Other ancillary materials can be downloaded from the “Handouts & Resources” area in the virtual classroom. Each course purchase includes a completion certificate issued to the participant after the course.

USER AGREEMENT

Your registration fee for a single participant entitles you to one telephone dial-in and one online course log-in per site. Course testing capabilities, stored results for training records, and completion certificates are available for only one registrant per single participant course purchase. For multiple participants, please purchase more than one registration or consider our 5 or 10 participant packages.

Is this course right for me? We’d be happy to help you select the right training course to meet your needs.
Give us a call at 215-675-1800 and use Option 3 (9am – 5pm EST, M-F) for assistance.

About Instructors

Michael Zhang
Michael Zhang, Regulatory Franchise Leader, Widler & Schiemann Ltd, Shanghai, China
Katrin Rupalla
Katrin Rupalla, SVP, Global Head Regulatory, Medical Documentation and RD Quality, H.Lundbeck A/S, Copenhagen, Denmark

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Clear
Duration: 90-Minutes
On-Demand
Includes Bonus Handouts!

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The Life Science Training Institute helps pharma, biotech, and medical device companies build knowledgeable, compliant workforces by providing training from drug discovery through commercialization. We are dedicated to advancing careers of those working to develop new therapies and to protect patient safety.

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