MEDICAL BIOTECHNOLOGY- PREMARKET & POSTMARKET REGULATION
This advanced course provides a comprehensive and nuanced understanding of the regulatory complexities governing the lifecycle of medical biotechnologies. It is designed for students with a background in law, biosciences, or regulatory affairs who wish to deepen their understanding of the legal and ethical aspects that guide biotechnology product development, premarket assessment, and postmarket surveillance. The course explores a range of topics from intellectual property rights, regulatory compliance, risk management, quality control, to bioethics. It also addresses the international variations in regulation and the key role of organizations like the FDA, EMA, and WHO.
Course Objectives:
-
To understand the legislative frameworks and regulatory bodies governing medical biotechnology.
-
To study the key stages in the lifecycle of biotechnology products, with an emphasis on premarket and postmarket regulations.
-
To evaluate the ethical, social, and legal implications of medical biotechnology and their influence on regulation.
-
To critically analyze and understand regulatory case studies and apply theoretical knowledge to practical scenarios.
-
To understand the role of international cooperation and harmonization in biotech regulation.
