Module 5: Clinical Trials, Pharmacovigilance and Future Industrial Prospects of Advanced Therapy

The fifth module of the Training Programme focuses mainly on the clinical trials, pharmacovigilance and patient safety of advanced therapy products (ATPs). As a new class of innovative medicine, there exists a number of different considerations throughout both the clinical trial and the post-marketing stages even if standards and guidelines have currently been set up by different authorities to regulate all pharmaceutical products. This module aims to provide the participants a general understanding on the concepts of clinical trials and pharmacovigilance specific to ATPs. Futhermore, the potential of biosimilars in future ATP development will also be discussed.

 

Learning Objectives:

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

  • Discuss the fundamentals of clinical trials regulation
  • Compare and contrast the differences in the regulation of ATP clinical trials between Hong Kong and Mainland China
  • Understand the importance of pharmacovigilance and patient safety of ATPs
  • Understand the importance of biosimilars and their potentials in the development of advanced therapy

 

Certification Requirements:

Please refer to our Programme Dashboard for details.

1
Session 5.1: Considerations and Implementation of Clinical Trials on Advanced Therapy: a Local Perspective
2
Assessment 5.1: Considerations and Implementation of Clinical Trials on Advanced Therapy: a Local Perspective
3 questions
3
Session 5.2: Regulation of Clinical Trials on Advanced Therapy Products in China
4
Assessment 5.2: Regulation of Clinical Trials on Advanced Therapy Products in China
3 questions
5
Session 5.3: Biosimilars for Advanced Therapy: Reality or Just Fantasy
6
Assessment 5.3: Biosimilars for Advanced Therapy: Reality or Just Fantasy
3 questions
7
Session 5.4: Post-marketing Pharmacovigilance of Advanced Therapies – The Example of Tisagenlecleucel
8
Assessment 5.4: Post-marketing Pharmacovigilance of Advanced Therapies - The Example of Tisagenlecleucel
3 questions