International Regulatory Affairs

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.