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.
