The third module of the Training Programme is designed to provide an overview of regulatory affairs in pharamceutical products, medical devices and other healthcare products. As advanced therapy products are now classified as pharmaceutical products in Hong Kong under the Pharmacy and Poisons Ordinance, it is essential for participants to learn the general step for guiding the registration of a pharamceutical product, and how this could be different compared to medical devices and other healthcare products. The programme also covers the Pharmaceutical advertisement from legal and industry perspectives. This module would help the participants to consolidate the concept and general principle of regulatory affairs, and prepare them to understand the requirements and challenges of ATP registration in different regulatory authorities which will be covered in the next module.
Learning Objectives:
By the end of this module, participants will be able to
- Understand the regulation of pharmaceutical products in Hong Kong, Macau and Mainland China.
- Recognize the importance of pharmaceutical advertisement and how it could be done from the viewpoints of legal and practical perspectives.
- Discuss the differences in regulatory framework between pharmaceutical products, medical devices and other healthcare products.
- Interpret the ICH guideline and prepare common technical documents for pharmaceutical product registration.
Certification Requirements:
Please refer to our Programme Dashboard for details.
