Good Pharmacovigilance Practices (GVP) Guidelines

Description

Good pharmacovigilance practices (GVP) are a set of measures designed to facilitate the performance of pharmacovigilance in separate countries.

This comprehensive training program provides an in-depth overview of the Canadian Good Pharmacovigilance Practices (GVP) Guidelines, ensuring compliance with Health Canada regulations. Participants will gain a thorough understanding of the key principles and requirements outlined in the GVP guidelines, covering all aspects of pharmacovigilance activities.

Training Objectives

• Understand the scope and applicability of the Canadian GVP Guidelines.
• Learn the key principles of pharmacovigilance, including risk management, signal detection, and risk minimization.
• Gain knowledge of the regulatory requirements for pharmacovigilance systems and processes.
• Develop an understanding of the roles and responsibilities of key personnel involved in pharmacovigilance activities.
• Learn to effectively manage adverse event reporting, case processing, and signal management.
• Understand the requirements for risk management plans and post-marketing safety studies.
• Learn how to comply with regulatory reporting requirements to Health Canada.
• Develop practical skills in applying GVP principles to real-world scenarios.

Target Audience

This training is designed for individuals involved in pharmacovigilance activities, including:

• Pharmacovigilance professionals
• Medical safety officers
• Regulatory affairs specialists
• Clinical research associates
• Medical writers
• Healthcare professionals involved in drug safety monitoring

Training Modules

• Module 1: Introduction
• Module 2: Serious Adverse Drug Reaction Reporting
• Module 3: Periodic Self-inspections – Personnel and Training
• Module 4: Annual Summary Report and Case Reports
• Module 5: Issue-related Summary Report – Maintenance of Records
• Module 6: Conclusion

Takeaway

Additional training documentation and certificates will be provided after the exam. Please note that a minimum score of 80% is required before the training certificate should be issued.

Author

Kossi Molley (il/he), Chemist, LSSBB; PMP
Chartered Trainer of the Labour Market Partners Commission

Please get in touch with us for group training!