Health Canada Cta Database

Listing Websites about Health Canada Cta Database

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Guidance Document For Clinical Trial Sponsors: Clinical

(5 days ago) WebCTA/CTA-A: Letters authorizing Health Canada to access related files (i.e.: a previously authorized CTA, Drug Master Files, Manufacturing Site Reference Files), if …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/clinical-trials/clinical-trial-sponsors-applications.html

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Health Canada's Clinical Trials Database Frequently Asked …

(4 days ago) WebThe database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. (CTA) …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/health-canada-clinical-trials-database/frequently-asked-questions.html

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Drug Product Database: Access the database - Canada.ca

(Just Now) WebAccess the database. Search the Drug Product Database (DPD) to find drugs authorized for sale by Health Canada. The DPD is updated nightly and includes: …

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html

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Health Canada Clinical Trial Applications (CTAs)

(5 days ago) WebThe Food and Drug Regulations provide authority to the Health Products and Food Branch (HPFB) of Health Canada to regulate the sale of drugs for the purposes of use in human …

https://healthresearch.healthsci.mcmaster.ca/manage-funding/clinical-research/health-canada-clinical-trial-applications-ctas/

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An Overview of Health Canada's CTA Process Altasciences

(8 days ago) WebWe conduct over 100 trials every year in Canada, and support the full range of first-in-human studies, specialty studies, and therapeutic areas, such as ophthalmology, CNS, …

https://canada.altasciences.com/e-bulletin/overview-health-canadas-cta-process

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Clinical Trials Database (CTA) API - health …

(7 days ago) WebThe database is managed by Health Canada and provides a source of information about Canadian clinical trials involving human pharmaceutical and biological drugs. This …

https://health-products.canada.ca/api/documentation/cta-documentation-en.html

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Clinical Trials Database (CTD) - Open Government Portal

(5 days ago) WebHealth Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. The database is managed by Health Canada and provides a …

https://open.canada.ca/data/en/dataset/d6fe4b32-2eaf-4ac0-9e35-b3841f25e3a7

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Description of the Figure D-1: Clinical Trial Applications - Health …

(5 days ago) Web1.4 Health Canada Summaries; 1.4.1 PSEAT-CTA; 1.7 Clinical Trial Information; 1.7.1 Study Protocol; 1.7.2 Informed Consent Forms; 1.7.3 Canadian Research Ethics Board …

http://hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/ctd/gd_prep_non_ectd_ld_longdesc-d1-eng.php

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An Overview Of Health Canada's CTA Process - clinicalleader.com

(2 days ago) WebIn this webinar, Altasciences' regulatory experts delve into essential insights about the Clinical Trial Application (CTA) regulatory submission process with Health Canada. By …

https://www.clinicalleader.com/doc/an-overview-of-health-canada-s-cta-process-0001

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Current state of Health Canada regulation for cellular and gene …

(7 days ago) WebIntroduction. Canadians have been pioneers in the field of stem cell research and regenerative medicine, with James Till and Ernest McCulloch leading the discovery …

https://www.sciencedirect.com/science/article/pii/S1465324919300416

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Guidance for Industry Preparation of the Quality Information …

(2 days ago) WebHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …

https://publications.gc.ca/collections/collection_2019/sc-hc/H164-242-2018-eng.pdf

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Regulatory submissions and transactions with Health Canada

(8 days ago) WebCTA submissions via eCTD is significant step in the propagation of eCTD. The adoption of eCTD for CTAs spawned from a successful pilot the health authority …

https://www.certara.com/blog/regulatory-submissions-and-transactions-with-health-canada/

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Health Canada - Canada.ca

(3 days ago) WebHealth Canada is responsible for helping Canadians maintain and improve their health. It ensures that high-quality health services are accessible, and works to reduce health …

https://www.canada.ca/en/health-canada.html

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Clinical Research Regulation For Canada ClinRegs

(5 days ago) WebHealth Canada. As per the CanadaFDA, the CanadaFDR, the G-CanadaCTApps, and CAN-29, Health Canada (HC) is the competent authority …

https://clinregs.niaid.nih.gov/country/canada

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Clinical Trial Applications (CTAs) - requirements

(5 days ago) WebThe following section provides the requirements for a CTA involving the use of pharmaceutical, biological, and radiopharmaceutical drugs. Publisher - Current …

https://open.canada.ca/data/en/dataset/213e9eac-2bc2-4844-a4ab-f6337ece0c6d

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Navigating Canadian Regulations for Oncology Clinical Research – …

(Just Now) WebThe Health Canada CTA approval process is a default 30-day deadline for a response to be received. 2) Does the sponsor need to have a Canadian office in order to …

https://scimega.com/exceed-oncology-trial-objectives-navigate-canadian-regulations-part-i/

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Health Canada Regulatory Modernization: Yesterday, Today …

(9 days ago) WebIn 2017, Health Canada started a five-year initiative on improving regulatory review of drugs and devices (R2D2)1. The goal of this initiative was to develop an agile regulatory …

https://www.certara.com/app/uploads/2021/03/WP_Health_Canada_Regulatory_Modernization.pdf

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Search criteria - Drug Product Database online query

(6 days ago) WebSearch criteria. You may search by either a) drug identification number (DIN), b) Anatomical Therapeutic Chemical (ATC) code, or c) by company or one or more of the …

https://health-products.canada.ca/dpd-bdpp/index-eng.jsp

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