Health Canada Hprc Review
Listing Websites about Health Canada Hprc Review
Guidance to market authorization holders on issuing …
(7 days ago) Health Canada and the MAH review the HPRC and dissemination strategy until both parties agree with the final drafts. The MAH is responsible for translating the HPRC and providing signed copies of the final HPRC to Health Canada. The third part of the HPRC process is the "dissemination, notification and … See more
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Guidance to market authorization holders on issuing …
(7 days ago) WEBHPRC dissemination strategy (distribution list and method of dissemination) Phase 2: Review and approval. Subsequent draft HPRCs with MAH edits; Translation of …
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Guidance to market authorization holders on issuing …
(6 days ago) WEBThe purpose of this document is to assist market authorization holders (MAHs) develop and disseminate health product risk communications (HPRCs). Scope. The guidance …
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Guidance to market authorization holders on issuing …
(1 days ago) WEBAn HPRC is a specific type of risk communication generated using the Health Canada-developed HPRC template and standardized process. HPRCs are designed to clearly …
https://publications.gc.ca/site/eng/9.910380/publication.html
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Canada Issues Final Rule Updating Hazardous Products
(7 days ago) WEBBy Phil Molé, MPH. 2023 is off to a quick start for new EHS regulations! Health Canada has just published a final rule to update its Hazardous Products …
https://www.ehs.com/2023/01/canada-issues-final-rule-updating-hazardous-products-regulations-hpr/
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Standardized Health Product Risk Communication Template
(9 days ago) WEBInformation for health care professionals. Additional detailed instructions on how the health professional should use the new safety information. Action taken by …
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Health Canada's Proposal to Accelerate New Drug Reviews
(3 days ago) WEBHealth Canada began a regulatory review of drugs and devices in 2017, and as part of this process, it issued a “Draft Guidance: Accelerated Review of Human Drug Submissions” …
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7294445/
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Important Safety Update on XELJANZ /XELJANZ XR …
(5 days ago) WEBreceiving XELJANZ/XELJANZ XR should be reported to Pfizer Canada ULC or Health Canada. Sincerely, Vratislav Hadrava M.D., Ph.D. Vice President & Medical Director …
https://www.pfizer.ca/files/XELJANZ_HPRC_Final_EN_12-Jan-2022.pdf
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Guidance to market authorization holders on issuing …
(2 days ago) WEBThe timeline to develop and disseminate an HPRC should be based on an assessment of the risk associated with a health product. Current Organization Name: …
https://open.canada.ca/data/en/info/77966866-d218-4a68-aaa4-f42378192418
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TERMS AND CONDITIONS - COVID-19 vaccines and …
(8 days ago) WEBHealth Canada’s review and records, prior to launch of the electronic platform, February 17, 22 Novovax Inc. is requested to develop and distribute a Health Product Risk …
https://covid-vaccine.canada.ca/info/pdf/nuvaxovid-authorisation.pdf
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3 c) Template for Dear Health Care Professional Letters
(4 days ago) WEBEvening Dose - Take all 3 tablets at the same time from the evening dose portion of the blister card (right half, blue side). For use under Emergency Use Authorization. Rx only. …
https://www.pfizer.ca/files/Final_PAXLOVID-HPRC_17Jan2022_EN.pdf
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Sotrovimab (sotrovimab) COVID-19 vaccines and treatments portal
(8 days ago) WEBFor COVID-19 authorizations, Health Canada can impose specific terms and conditions on the authorization. This allows Health Canada to continue to gather information on the …
https://covid-vaccine.canada.ca/sotrovimab/product-details
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Guidance to market authorization holders on issuing health
(6 days ago) WEBThe RCS will work with MAHs to develop a critical path for each HPRC, on a case-by-case basis, based on the level of urgency. To help MAHs visualize the …
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Guide for using the Standardized Health Product - Minister of …
(5 days ago) WEBPurpose. This guide is intended to assist in the drafting of risk communications, using the standardized template to communicate health product safety …
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Health Professions Appeal and Review Board
(1 days ago) WEBThe Board recommends that all requests for review, submissions, materials, and inquiries be sent via email to [email protected] or faxed to HPARB at 416-327-8524. …
https://www.hparb.on.ca/scripts/english/default.asp
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Important Safety Information on ZEJULA (niraparib) - Update …
(2 days ago) WEBAction taken by Health Canada Health Canada will review all available information that will be submitted by GSK and further communicate if any action is …
https://ca.gsk.com/media/6974/1383-zejula_niraparib-hprc_final_osb_20230213-en.pdf
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Niraparib (Zejula) for Ovarian Cancer - Details CDA-AMC - CADTH
(Just Now) WEB100 mg. Tumour Type: Gynecology. Indications: Ovarian Cancer. Funding Request: As monotherapy for the maintenance treatment of female adult patients with …
https://www.cadth.ca/niraparib-zejula-ovarian-cancer-details
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Health and Biosciences: Targeted Regulatory Review - canada.ca
(3 days ago) WEBLast update: January 2021. The Health and Biosciences Sector Regulatory Review Roadmap outlines Health Canada's plan to address the issues, irritants, and …
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Federal panel lists 35 'plausible' future threats to Canada and the
(4 days ago) WEBA federal government panel's report lists extreme weather-driven events like wildfires as one of the key near-term threats to Canada and the world. (B.C. Wildfire …
https://www.cbc.ca/news/politics/next-disruptions-on-the-horizon-1.7207915
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TERMS AND CONDITIONS - COVID-19 vaccines and …
(7 days ago) WEB7 AstraZeneca Canada Inc. is requested to develop and distribute a Health Product Risk Communication (HPRC), in French and English, should a decision be made to …
https://covid-vaccine.canada.ca/info/pdf/astrazeneca-covid-19-vaccine-authorisation.pdf
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Canada's new cancer figures reflect a mixed message: study
(6 days ago) WEBCancer is the leading cause of premature death, researchers said in Monday's issue of the Canadian Medical Association Journal. It also accounted for 25 …
https://www.cbc.ca/news/health/cancer-cmaj-may-1.7200589
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Black youth face barriers in mental health care access: experts
(2 days ago) WEBFante-Coleman, who is speaking at the Saturday conference, said a Canadian study from 2015 showed Black-Caribbean children and youth waited an …
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Health Canada's Regulatory Stock Review Plan: 2023 to 2025
(1 days ago) WEB2023-07-10. The Regulatory Stock Review Plan is a public list and description of planned reviews of regulations that Health Canada plans to undertake within a three-year …
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Health minister introduces bill to split up Alberta Health Services
(7 days ago) WEBNew organizations for acute care, primary care, continuing care and mental health and addictions. Health Minister Adriana LaGrange introduced Bill 22 in the …
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Dissolution of the Health Professions Regulatory Advisory Council …
(2 days ago) WEBThe Regulated Health Professions Act, 1991, (RHPA) is the governing framework for the regulation of health professions in Ontario. The RHPA sets out a number of roles and …
https://www.ontariocanada.com/registry/view.do?postingId=37050
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