(3 units). Introduction to Canadian Acts, Regulations and Guidelines pertaining to registration of agents affecting humans, animals and/or the environment. Comparative information on international trends and regulations. Basic knowledge for preparing submission packages in support of registration of new biopharmaceutical products. Discussion on the submission review process undertaken by Canadian regulatory agencies in carrying out detailed risk assessment of new products. Not necessarily offered every year. Course Component: Lecture
(3 units). Introduction to Canadian Acts, Regulations and Guidelines pertaining to registration of agents affecting humans, animals and/or the environment. Comparative information on international trends and regulations. Basic knowledge for preparing submission packages in support of registration of new biopharmaceutical products. Discussion on the submission review process undertaken by Canadian regulatory agencies in carrying out detailed risk assessment of new products. Not necessarily offered every year. Course Component: Lecture
