Module 4: Asia Perspectives for ATP Regulation: Challenges and Opportunities

The fourth module of the Training Programme specifically focuses on the regulation of advanced therapy products in Hong Kong, Macau and Mainland China. This module does not only help participants to understand the ATP regulation framework in Greater China Area, but also to provide them with an industrial aspect on the registration of ATP.

 

Learning Objective

By the end of this module, participants will be able to

  • Understand the ATP regulation in Hong Kong, Macau and Mainland China.
  • Discuss the differences in ATP regulatory framework between regions in Greater Bay Areas.
  • Understand the technical requirements and challenges on registering ATP in Hong Kong.
  • Identify the opportunity of intellectual properties in ATPs.

 

Certification Requirements:

Please refer to our Programme Dashboard for details.

1
Session 4.1: Regulations of Advanced Therapy Products in Hong Kong
2
Assessment 4.1: Regulations of Advanced Therapy Products in Hong Kong
3 questions
3
Session 4.2: Practical Issues and Experience of ATP Registration in Hong Kong
4
Assessment 4.2: Practical Issues and Experience of ATP Registration in Hong Kong
2 questions
5
Session 4.3: Regulations of Advanced Therapy Products in China
6
Assessment 4.3: Regulations of Advanced Therapy Products in China
3 questions
7
Session 4.4: Intellectual Properties in ATP: A Case Study on Global Patents in the Field of CAR-T Cell Therapy
8
Assessment 4.4: Intellectual Properties in ATP - A Case Study on Global Patents in the Field of CAR-T Cell Therapy
3 questions
9
Session 4.5: The scientific Principles of Cell and Gene Products - Part 2
10
Assessment 4.5: The Scientific Principles of Cell and Gene Products - Part 2
4 questions