Clinical Research, Drug Safety, and Pharmacovigilance Diploma Program

AAPS is the first Canadian College that designed, prepared and started to offer this ministry-approved program in Canada.

The Clinical Research, Drug Safety, and Pharmacovigilance Diploma program is designed to develop specialized knowledge and skills required to design and write study protocols, monitor and manage clinical trials and to conduct drug safety and Pharmacovigilance activities including adverse reaction reporting, preparing periodic safety update reports and in, establishing and managing Risk Evaluation and Mitigation Strategies in compliance with Canadian, US regulations and international guidelines.

The program focuses on the global as well as Canadian health care system and regulatory agencies, health care legislations, international guidelines, and standard operating procedures (SOP) and practices for managing clinical studies and drug safety activities. Using practical and current real cases, AAPS integrated a unique approach and provides students with the foundation and practical knowledge to formulate a sound clinical development plan; ensure clinical trial data is credible and accurate; and that the rights, integrity and confidentiality of trial subjects are protected. AAPS graduates from the Clinical Research, Drug Safety and Pharmacovigilance program pursue careers in the Pharmaceutical, Biotechnological, Medical devices, Cosmetics, Natural health Products, and Allied industries.

A Clinical Research Associate, also known as a Monitor, is an individual that oversees the progress and conduct of a clinical trial. A clinical trial is usually implemented by physicians at a hospital, clinic, or physician’s office. The CRA is required to oversee the initiation, progress, and conduct of the clinical trial to ensure the scientific integrity of the data collected, and the protection of the rights, safety, and well-being of human study subjects.

The CRA frequently has a health care or science background (e.g. nurse, medical technologist, or physical therapist; or Bachelor’s, Master’s, or a Ph.D. in a science). The CRA is usually employed by a pharmaceutical company, contract research organization (CRO), academic institution, or site management organization. A CRA can work either in-house or in the field, requiring some travel. A field monitor will visit multiple sites and interacts with the study coordinator and the investigator conducting the trial.

A Pharmacovigilance associate, is an individual that oversees the progress and conduct of drug safety and Pharmacovigilance activities. Pharmacovigilance is the science of collecting, assessing, reporting and prevention adverse drug reactions and the Pharmacovigilance system is usually complemented by a Pharmaceutical company in order to have the infrastructure necessary to perform Pharmacovigilance tasks. The Pharmacovigilance associate is required to perform passive, and active Pharmacovigilance activities that are including reporting of adverse drug reaction to health authorities and preparing and managing pharmacoepidemiological studies for the protection of the safety, and well-being of human study subjects and the general population once a drug enters the market.

Pharmaceutical companies are presently seeking to reduce the development time necessary for their products to receive Health Canada or FDA approval for marketing. Monitoring of a clinical trial is the first mechanism in identifying potential data discrepancies and regulatory issues. In addition, Pharmacovigilance includes activities to monitor the safety profile of a drug. Inadequate monitoring can jeopardize the safety of the study participant and/or may lead to the delay in gaining drug approval.

A well-trained and knowledgeable clinical research and Pharmacovigilance professional plays a vital role in protecting the study participant and the general population for marketed drugs and in helping to reduce the time between drug development and marketing approval. The demand for knowledgeable and trained Clinical Research and Pharmacovigilance professionals continues to grow, as supply is limited.