As the global market for medicinal products is expanding, the need for biotech companies to understand the regulatory issues 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 regulatory requirements of product registration for pharmaceutical and biological products in Australia, Canada, Europe, Japan, and other emerging 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, Quality Systems, interfacing with regulatory Agencies, and post-market vigilance. Medical devices will be covered along with several regulatory hot topics.
Course Number: BIOL-40255 Credit: 2 units