Clinical Research Certificate

AAPS is pleased to offer these certificate programs in Clinical Safety and Pharmacovigilance for the first time in Canada. New pharmaceuticals must be shown to be of good quality, effective and safe for their intended purposes. Clinical research is an important process to ensure their ongoing safety and public confidence in the regulatory system.

Students can attend convenient evening classes in this applied training to advance their careers
in this in-demand profession.

Clinical Research Certificate

The Canadian Pharmaceutical Industry: Big Picture: Gain an understanding of the steps involved in preparing pharmaceutical products – from research & development, to testing products, to marketing. This course also covers the steps in testing pharmaceutical products for efficiency and reporting safety issues for when creating new drug submissions to Health Canada, and maintaining a drug on the market.

Introduction to Clinical Research and Drug Safety: This course familiarizes students with the Canadian and international perspectives of the clinical research, and clinical safety and pharmacovigilance functions of the drug development process.

Legislations, Guidelines and Ethics in Clinical Research and Drug Safety: Learn about standards and regulations as they relate to the clinical research, clinical safety, and pharmacovigilance functions in the industry. Gain an overview of important historical documents, as well as modern reports and policies.

Physiology and Pathophysiology: Review the basic mechanisms underlying physiological and pathophysiological states, and learn how to apply these concepts to the pathophysiology of specific disorders using a systemic approach. Gain a fundamental understanding of all systems, their function, and the mechanism of action of development of pathological changes.

Clinical Research Regulations and Good Clinical Practices (GCP): This course provides an introduction to good clinical practices (ICH-GCP) as they apply to international regulations and guidelines for Clinical Research.

Pharmaceutical Biotechnology: This course covers a broad range of topics on products and technologies used in the health care system. Students will learn to apply knowledge of biotechnology to clinical research strategies and clinical safety monitoring activities.

Medical Devices: Gain an introduction to the field of medical devices, and learn about the regulatory approval process for today’s medical devices used in the industry.

Organization of Clinical Trials and Clinical Monitoring Plan Development: This course will outline the various stages of clinical research, as well as the activities for monitoring clinical trial sites.

Clinical Project Management and Project Chart Development: Learn valuable project management skills and values and discover how it plays a role in structuring work in the pharmaceutical and biotechnology industries.

Clinical Data Acquisition, Data Management and Biostatistics: Learn the essentials of clinical research and drug safety data entry, computer systems, ICH guidelines for electronic data management, drug safety and pharmacovigilance data analysis, and more.

Clinical Research SOP Development: This course outlines the medical and regulatory aspects of clinical research procedures and SOP development. Learn the multiple support functions of the clinical research and regulatory affairs department.

Clinical Study Protocol and Investigator’s Brochure Development: Examine and evaluate the support functions of clinical research and regulatory affairs, including label changes, patient information and safety reporting.

GCP and GVP Inspections and Audits: Students will develop the necessary tools and skills to prepare and host a regulatory inspection, and to facilitate the response and follow-up to inspection findings in the clinical research and pharmacovigilance fields.

Global Clinical Research and Pharmacovigilance: Learn what goes into global clinical trials activities, and global pharmacovigilance systems and processes in various organizations and countries.

Pharmaceutical Job Application and Interview Training: This course will help students develop interpersonal communication skills such as active listening, presentation, and interviewing.

Clinical Research, Drug Safety, Pharmacovigilance Project: Under the supervision of the course professor, students will consider important factors and complete a research paper that attempts to contribute to the field by further developing research documented in the literature, or proposing a new direction for further research.