Drug Safety and Pharmacovigilance Certificate
AAPS is the first college in Canada to offer the Certificate in Clinical Safety and Pharmacovigilance. Pharmacovigilance is an essential process of ensuring the safety of new drugs taken to market, particularly for evaluating previously unreported adverse reactions. Students can attend convenient evening classes in these important subjects to get the relevant training necessary to advance their careers.
Drug Safety and Pharmacovigilance Certificate Courses
Introduction to Pharmacovigilance Activities and Pharmacoepidemiological Studies: This course focuses on important topics in pharmacoepidemiology, including relevant principles of pharmacology, case reports, study design considerations, and much more.
Clinical Pharmacology and Clinical Safety Assessments: Students will be introduced to the fundamentals of clinical pharmacology. Learn about the relationship between a drug’s mechanism of action at the molecular level and its effect on the patient in relation to clinical research and clinical safety.
Pharmacovigilance Regulations and Good Pharmacovigilance Practices (GVP): This course serves as an introduction to international regulations and guidelines on good pharmacovigilance practices in the industry.
Adverse Drug Reaction Reporting:Learn the essentials of clinical data entry, computer systems, and ICH guidelines for electronic data management in clinical research and drug safety.
Clinical Study and Safety Reporting Activities: Explore how to apply your to knowledge in clinical study and safety reporting for writing various types of update reports including study reports and periodic safety reports.
Post-Marketing Compliance for Safety Monitoring: This course outlines the post-marketing support functions of a regulatory affairs department including adverse events reporting, literature reviews, label changes and post-marketing surveillance techniques.
GCP and GVP Inspections and Audits: Develop the necessary skills and tools to prepare and host a regulatory inspection at various sites in the clinical research and pharmacovigilance fields. This course also covers facilitating the response and follow-up to the inspection findings.