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.
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
Please refer to our Programme Dashboard for details.