CCCEP Number: 1684-2022-3542-L-P
This course is accredited for pharmacists in Canada as per the CCCEP requirements and has been accredited by the CCCEP for 7 CEUs. The Canadian Council on Continuing Education in Pharmacy (CCCEP) is a national organization established to accredit continuing pharmacy education programs intended to be delivered to pharmacy. CCCEP accreditation is recognized by the pharmacy regulatory authorities in all provinces and territories of Canada.
This course is designed to introduce international regulations and guidelines to industry on good pharmacovigilance practices and pharmacoepidemiologic assessment of observational data regarding drugs, including biological drug products and specifically guidance on safety signal identification, pharmacoepidemiologic assessment and safety signal interpretation and pharmacovigilance plan development.
Learning Objectives
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.
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