Open Government Portal

Open Data Portal Catalogue Dataset
Found 20921 records

Educational module includes an outline of Vanessa’s Law, who/what/when of regulations for mandatory reporting of adverse drug reactions and medical …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 1 overview Vanessa’s Law reporting requirements mandatory reporting Adverse Drug Reactions Medical Device Incidents Hospitals

Educational module includes considerations for mandatory reporting of adverse drug reactions and medical device incidents, reporting options to Health Canada, …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 2 reporting processes mandatory reporting educational module adverse drug reactions medical device incidents reporting options reactions incidents problems

Educational module helps identify and overcome barriers to hospital mandatory reporting of adverse drug reactions and medical device incidents, recognize …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 3 Strategies mandatory reporting educational module barriers hospital mandatory reporting adverse drug reactions medical device incidents

Educational module provides overview of health product vigilance, report management, post-market surveillance activities and Health Canada risk communications.

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Module 4 safety findings Educational module health product vigilance report management post-market surveillance Health-Canada risk communications.

This notice is being issued to clarify to drug manufacturers and sponsors that elements of Risk Management Plans (RMPs) required …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Notice of clarification drug manufacturers sponsors Risk Management Plans controlled distribution programs Canadian Reference Products generic drug conducting comparative testing

We are issuing this notice to help drug manufacturers and sponsors when preparing the Canadian-specific considerations and elements in the …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Notice of clarification drug manufacturers sponsors Canadian-specific considerations risk management plans certain drug products

Health Canada’s Evolving Approach to Leveraging Real World Evidence (RWE) for Drug Regulatory Decisions.

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: optimizing use of Real-World-Evidence leveraging Real-World-Evidence inform Regulatory Decision-Making Drug Regulatory Decisions

This guidance document provides market authorization holders (MAHs) with assistance on how to comply with the Food and Drugs Act, …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Overview guidance-document reporting adverse reactions Marketed Health Products Industry market authorization holders

Health Canada sets the standards for health product advertising material in Canada to help advertisers produce messages that are not …

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Health-Products health-product advertising material regulating advertising of Health-Products standards advertisers produce messages not false misleading deceptive messages

Learn how Health Canada makes sure that the health products you use are safe, effective and of high quality.

Last Updated: Apr 4, 2024
Date Published: Apr 2, 2024
Publisher: Health Canada
Formats: HTML
Keywords: Regulating health products safety of health products effective-and-high quality health products monitoring safety-and-quality approving health products