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 provide students with a comprehensive understanding of the regulatory framework, ethical considerations, and principles of good pharmacovigilance practices (GVP) in drug development and post-marketing surveillance. The course will cover the laws and regulations governing drug safety and pharmacovigilance in North America and globally.
Students will learn about the ethical considerations and informed consent process for clinical research and post-marketing surveillance, including the protection of human subjects and the role of Institutional Review Boards (IRBs) and Ethics Committees. The course will also cover the regulatory requirements for the collection, assessment, and reporting of adverse events, including the development of risk management plans and post-marketing surveillance studies.
The course will focus on the principles of GVP, including the importance of quality control and assurance in pharmacovigilance, and the responsibilities of sponsors, investigators, and pharmacovigilance professionals. Students will learn about the principles of data management and the importance of maintaining accurate and complete study documentation.
Upon completion of the course, students will have a thorough understanding of the regulatory framework, ethical considerations, and principles of GVP. Students will also be prepared to apply this knowledge to the design and conduct of clinical trials and post-marketing surveillance studies to ensure compliance with regulatory requirements and to safeguard patient safety.
Learning Objectives
