The Regulatory Affairs for Preclinical and Clinical course provides a comprehensive overview of drug development and regulatory compliance for professionals involved in preclinical and clinical research. It covers a wide range of topics, including Drug Discovery and Preclinical Studies, GCP, Ethics, DMC, Clinical Studies, and CTAs – Phase I, IIa/b, III.
This course begins with an introduction to Drug Discovery and Preclinical Studies, followed by an overview of the regulatory requirements for preclinical studies, including GLP compliance and FDA guidelines. The next section of the course focuses on Good Clinical Practice (GCP) and Ethics, which are essential components of clinical research. Participants will learn about the principles of GCP and the ethical considerations that must be taken into account when designing and conducting clinical trials.
This course also covers the different phases of clinical trials (Phase I, IIa/b, and III) and the regulatory requirements associated with each phase. Participants will gain an understanding of the Clinical Trial Application (CTA) process and the required documents for submission to regulatory agencies.
Additionally, this course provides an overview of regulatory requirements during trial conduction, including the reporting of Adverse Events (AE) and Serious Adverse Events (SAE). Participants will learn about the importance of AE/SAE reporting, timelines, and procedures for reporting. This course will also cover safety analysis, Investigator’s Brochure (IB) updates, and essential study document maintenance.
Throughout this course, participants will learn about the Canadian and US health care systems and research structures for trials. They will also gain insight into essential committees, including the REB/ERB/IRB and DMC/DMSC, which are critical to clinical research.
The course concludes with an overview of HC Inspections (HC Inspectorate and inspection program), audits, and their checklists. By the end of this course, participants will have a solid understanding of the regulatory landscape for preclinical and clinical research. They will also gain practical skills and knowledge that they can apply to their work in regulatory affairs.
By the end of the course, participants will have a solid understanding of the regulatory landscape for preclinical and clinical research, including the requirements for drug development, clinical trial design and conduct, and regulatory compliance. Participants will also gain practical skills and knowledge that they can apply to their work in regulatory affairs.