Regulatory Affairs in China – The New Drug Regulatory Framework

Teachers
Michael Zhang
Katrin Rupalla
Category:
Clinical Trials (GCP Training)/ Live Webinars/ Regulatory & Compliance/ Research & Development/
Clear
Duration: 90-Minutes
July 16, 2020 | 1 PM EDT
Includes Bonus Handouts!

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 will be offered live. With your course purchase, you may participate live or view the recording at your convenience (available for 30 days). Access instructions for the live viewing will be emailed to you 3 business days prior to the scheduled date. Access to the recorded version will be available 1 business day after the live course has run.

To access the course, you need only a telephone and computer with internet access.

This webinar is scheduled for live instruction on
Date: July 16, 2020
Time: 1:00 – 2:30 PM EDT

Choose to participate live or listen to the recording afterward!

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.

The recorded version of the training will be available for 30 days after purchase.

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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