Health Product Safety & Pharmacovigilance

Description

Health Product Safety & Pharmacovigilance

This comprehensive training program provides an in-depth overview of:

• The Canadian Good Pharmacovigilance Practices (GVP) Guidelines, ensuring compliance with Health Canada regulations.
• The knowledge and skills necessary to effectively identify, document, and report adverse reactions (ARs) associated with marketed health products.
• the knowledge and skills necessary to prepare and submit compliant summary reports for marketed drugs and natural health products in accordance with Health Canada’s guidance document.

Participants will gain a thorough understanding of:

• The key principles and requirements outlined in the GVP guidelines covering all aspects of pharmacovigilance activities.
• The regulatory guidelines, best practices, reporting mechanisms, and the importance of pharmacovigilance in ensuring patient safety.
• The regulatory requirements, reporting timelines, data collection methodologies, and documentation standards mandated by Health Canada for monitoring the safety profile of post-market products.

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

• Lesson 1: Good Pharmacovigilance Practices (GVP) Guidelines
• Lesson 2: Reporting Adverse Reactions to Marketed Health Products
• Lesson 3: Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products

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

Please get in touch with us for group training!