Description
Elevate your regulatory compliance with our comprehensive on-demand Training on “Preparing and Submitting Summary Reports for Marketed Drugs and Natural Health Products (PSSR).”
This training program is designed to equip regulatory affairs professionals with 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. The training focuses on the regulatory requirements, reporting timelines, data collection methodologies, and documentation standards mandated by Health Canada for monitoring the safety profile of post-market products.
Learning Objectives
By the end of this training, participants will be able to:
- Understand the regulatory framework governing summary reporting requirements
- Distinguish between different types of summary reports and their requirements
- Collect and analyze appropriate data for inclusion in summary reports
- Prepare comprehensive and compliant Annual Summary Reports (ASRs)
- Respond effectively to requests for Issue-Related Summary Reports (IRSRs)
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: PSSR-Introduction
- Module 2: PSSR-Annual Summary Report
- Module 3: PSSR-Issue-Related Summary Reports
- Module 4: PSSR-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
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