CCCEP Number: 1684-2023-3609-I-Z
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 activity is designed to orient students to the Drug Development Process, clinical research process, and how clinical safety and pharmacovigilance functions within the corporate and regulatory context from Canadian and international perspectives. The activity also provides a comprehensive introduction to the clinical research process and its history and evolution. Development of drugs is used as a model. Students will learn about the responsibilities of the principal investigator, the sponsor, and the patient, in addition to the responsibilities of the review ethics board. Upon completion, participants will be able to prepare an organizational chart depicting a typical research team, defining the roles or responsibilities of each member. The participant should also be able to describe the product approval process and discuss the general conduct of a typical clinical trial.
Taking a new pharmaceutical product from the laboratory to the market requires years of bench research, and nonclinical research to assess the safety profile of the new drug. The most important element of the early discovery process is to select the best new molecular entities to enter clinical trials and to limit failure in full development. The next phase is careful clinical research on human subjects to assess the safety and efficacy of your product, constant interactions with drug agencies, manufacturing your product in the most efficient manner compliant with the appropriate regulations.
This course is designed to introduce the students to the main steps of the drug development process, from drug discovery, and preclinical animal testing to all phases of clinical research and post-approval drug safety surveillance from the US and international regulatory perspectives.
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