Clinical Safety and Pharmacovigilance

The Clinical Research, Drug Safety and Pharmacovigilance Certificate courses are designed to develop specialized knowledge in the most recent developments in clinical research, drug development and pharmacovigilance. Students will learn Good Clinical Practices (GCP), regulatory framework of drug development, organization and management of clinical studies conducted across multiple phases to assess the safety and effectiveness of medications, vaccines, and devices, as well as quality assurance concepts, and current pharmacovigilance methodologies, including Good Pharmacovigilance Practices (GVP).

These courses focus on the global healthcare system as well as the Canadian healthcare system, Canadian regulatory agencies, health care legislation, international guidelines, and standard operating procedures (SOP). Using practical and current real cases, AAPS integrates 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.

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.

The program focuses on topics delivered through 15 modules:

• The Canadian Pharmaceutical Industry: Big Picture
• Introduction to Clinical Research and Drug Safety
• Legislations, Guidelines and Ethics in Clinical Research and Drug Safety
• Introduction to Statistical Analysis
• Clinical Research Regulations and Good Clinical Practices (GCP)
• Pharmaceutical Biotechnology
• Medical Devices
• Organization of Clinical Trials and Clinical Monitoring Plan Development
• Clinical Project Management and Project Chart Development
• Clinical Data Acquisition and Data Management
• Clinical Research SOP Development
• Clinical Study Protocol and Investigator’s Brochure Development
• GCP and GVP Inspections and Audits
• Global Clinical Research and Pharmacovigilance
• Clinical Research, Drug Safety and Pharmacovigilance Project

A well-trained and knowledgeable Drug Safety 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.