Regulatory Affairs Professionals Society 69 Health Product Vigilance and Risk Management Updated by Christopher Antonio, Roshni Celeste, Jenna Griffiths, Carole Légaré, Marc Poitras, Tanya Ramsamy, Thanh Vu, Bruce Wozny and Raymond Yang Chapter 7 OBJECTIVES ‰ ‰ Understand the reporting requirements for safety information arising during clinical trials for pharmaceuticals, biologics, radiopharmaceuticals and natural health products ‰ ‰ Understand the reporting requirements for post- approval safety information for pharmaceuticals, biologics, radiopharmaceuticals and natural health products ‰ ‰ Understand the requirements for Risk Management Plans LAWS, REGULATIONS AND GUIDELINES COVERED IN THIS CHAPTER Drugs, Biologics and Natural Health Products ‰ ‰ Reporting Adverse Reactions to Marketed Health Products - Guidance Document for Industry (May 2018) ‰ ‰ Guidance for Industry: Clinical Safety Data Management Definitions and Standards for Expedited Reporting ICH Topic E2A (1995) ‰ ‰ Notice: Adoption of the International Conference on Harmonisation (ICH) Guidance on Periodic Benefit Risk Evaluation Report - ICH Topic E2C (R2) (March 2013) ‰ ‰ Development Safety Update Report (DSUR) E2F (July 2012) ‰ ‰ Guideline for Good Clinical Practice E6(R2) (November 2016) Drugs and Biologics ‰ ‰‰ Food and Drug Regulations (C.R.C., c. 870) ‰ Good Pharmacovigilance Practices (GVP) Guidelines GUI-0102 (August 2013) ‰ ‰ Guidance Document for Clinical Trial Sponsors: Clinical Trial Applications (May 2013) ‰ ‰ Notice Regarding Implementation of Risk Management Planning including the adoption of ICH Guidance Pharmacovigilance Planning—ICH Topic E2E (February 2009) ‰ ‰ Post-approval safety data management: Definitions and standard for expedited reporting E2D Natural Health Products ‰ ‰ Guidance Document: Clinical Trials for Natural Health Products (October 2005) ‰ ‰ Natural Health Products Regulations (SOR/2003-196) Introduction Health product vigilance is an evolving science. This chapter discusses pharmacovigilance and natural health product vigilance. In Canada, the health product vigilance system is governed by regulations describing the responsibilities of
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