As the global market for medicinal products expands, the need for biotech companies to understand the changing regulations in established global regions, as well as in developing countries, is becoming more critical. This course provides an excellent overview of the regulatory systems and agencies in the key global regions involved in the development of medicinal products. The requirements of product registration for pharmaceutical and biological products in Australia, Canada, Europe, Japan, and other regions such as China, India, and Latin America will be described. Topics include: product designations, regulations and guidance, regulatory pathways and options, document submission requirements, interfacing with regulatory Agencies, and post-market vigilance. Medical devices will be covered. Regulatory hot topics will be discussed.
Course Number: BIOL-40303
Credit: 3.00 unit(s)
There are no sections of this course currently scheduled. Please contact the Science & Technology department at 858-534-3229 or firstname.lastname@example.org for information about when this course will be offered again.