LO1: Describe the standards and regulations framework related to clinical research, clinical safety, and pharmacovigilance functions.
LO2: Understand the significance of the Nuremberg Code, the Belmont Report and the Declaration of Helsinki, International Conference on Harmonization (ICH) guidelines.
LO3: Discuss the different GxP areas (GCP, GMP, GVP etc.) and reporting of adverse reactions and trials in special populations.
LO4: Discuss the Food and Drugs Act, SAP program and privacy legislation (PIPEDA).
LO5: Understand AE/ADR classification, assessment, and reporting standards.
LO6: Review pharmacovigilance process and documentation requirements.