Health Canada Variation Guidance
Listing Websites about Health Canada Variation Guidance
Guide to validation – drugs and supporting activities (GUI-0029)
(2 days ago) WEB2004 (revised 2009) Health Canada document to provide guidance to the pharmaceutical industry in dealing with validation issues for sterile and non-sterile …
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COVID-19 variants of concern
(3 days ago) WEBMost notably the following have been detected in Canada and are considered variants of concern: Alpha (B.1.1.7) Beta (B.1.351) Gamma (P.1) Delta (B.1.617) Omicron …
https://sac-isc.gc.ca/eng/1615991390358/1615991423624
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COVID-19 epidemiology update: Testing and variants — Canada.ca
(4 days ago) WEBTesting in Canada for COVID-19. On December 5, 2022, we changed surveillance systems for monitoring laboratory testing of SARS-CoV-2, the virus that causes COVID-19. We …
https://health-infobase.canada.ca/covid-19/testing-variants.html
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Guidance document : post-notice of compliance (NOC) : changes : …
(1 days ago) WEBGuidance document : post-notice of compliance (NOC) : changes : quality document.: H164-281/2019E-PDF "The first version of Health Canada’s Post‐Notice of Compliance …
https://publications.gc.ca/site/eng/9.875014/publication.html
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Guidance document : post-notice of compliance (NOC) changes : …
(1 days ago) WEBHealth Canada, issuing body. Title : Guidance document : post-notice of compliance (NOC) changes : safety and efficacy document (for pharmaceutical, biologic and …
https://publications.gc.ca/site/eng/9.880801/publication.html
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Best Practices for the Development, Scale-up, and Post-approval …
(3 days ago) WEBWhere there are differences between Health Canada data requirements to support pre- and post-NOC changes, In 2003 , the Variations Guidance was …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4037495/
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Canada hesitates to update public health guidelines on risk from
(3 days ago) WEBBut I think the science has evolved, or at least our thinking has evolved." Canada quietly updates COVID-19 guidelines on risk of airborne spread. PHAC was …
https://www.cbc.ca/news/health/coronavirus-variants-canada-risk-1.5901797
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Notice: Update on Health Canada’s Implementation of ICH’s Q12 …
(7 days ago) WEBAs part of Health Canada’s (HC) implementation of the new International Council for Harmonisation’s (ICH) Q12 guideline, we are pleased to announce the …
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Health Canada Draft Revised Guidance Documents on Post-NOC
(7 days ago) WEBOn August 6, 2021, Health Canada issued five draft revised Guidance Documents on Post-Notice of Compliance (NOC) Quality Changes for stakeholder …
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Post-approval Changes – Stability Requirements and Regulations
(1 days ago) WEBWHO (February 2007) Annex 6 variations guidance: guidance on variations to a prequalified product dossier. Google Scholar Health Canada (February …
https://link.springer.com/chapter/10.1007/978-0-387-85627-8_5
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Guidance Document
(2 days ago) WEBHealth Canada Address Locator 0900C2 Ottawa, ON K1A 0K9 Tel.: 613‐957‐2991 Toll free: 1‐866‐225‐0709 Fax: 613‐941‐5366. TTY: 1‐800‐465‐7735. E‐mail: …
https://publications.gc.ca/collections/collection_2021/sc-hc/H164-271-2019-eng.pdf
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Health Canada Implementation of ICH Q12: CMC Changes
(Just Now) WEBHealth Canada is partially aligned • Concept is well understood –we have our CPID (Certified Product Information Document) • Concept of PLCM has been introduced …
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Guidance Document
(2 days ago) WEBguidance posted on the Health Canada website. Updates to this guidance reflect a modification of the reporting category for safety changes from a Notifiable Change to a …
https://publications.gc.ca/collections/collection_2021/sc-hc/H13-9-31-2019-eng.pdf
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Guidance on the use of COVID-19 vaccines during the fall of 2024
(5 days ago) WEBThe monitoring of the risk of ischemic stroke should account for potential confounding factors, including variation in stroke incidence by calendar period. Public Health …
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Post-NOC Changes – Quality Guidance Overview and Update
(3 days ago) WEBRelaxation of an acceptance criteria (Cont’d) Principal Supporting Data Requirements: Updated specification with justification for the change. If a Schedule B standard is …
https://capra.ca/_uploads/58824e351b51c.pdf
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Summary: Guidance on the use of COVID-19 vaccines during
(3 days ago) WEBOn May 3, 2024, the Public Health Agency of Canada (PHAC) released the National Advisory Committee on Immunization's (NACI) Guidance on the use of COVID-19 …
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Health Canada on Significant Changes: Guidance for Implementation
(8 days ago) WEBAug 4, 2021. Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a notice and guidance for implementation dedicated to …
https://www.regdesk.co/health-canada-on-significant-changes-guidance-for-implementation/
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ISPE Team Assists Health Canada with Training on ICH Q12 …
(4 days ago) WEBISPE’s Q12 Implementation Team. ISPE’s PQLI® initiative was created to provide guidance on practical implementation of the concepts described in ICH …
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