Capra.ca

Health Canada’s Proposal for Clinical Trials Regulatory

WebPublished on July 16, 2021. On May 20, 2021 Health Canada opened a consultation on its proposal to modernize the regulatory framework for clinical trials related to human drugs, …

Actived: 4 days ago

URL: https://capra.ca/en/blog/health-canadas-proposal-for-clinical-trials-regulatory-modernization-2021-07-16

Canadian Association of Professionals in Regulatory …

WebThe Canadian Association of Professionals in Regulatory Affairs (CAPRA) is an organization dedicated to providing its members with opportunities to enhance their professional …

Category: Health Go Health

Health Canada Draft Revised Guidance Documents on Post-NOC

WebHealth Canada is now proposing to divide this guidance into four separate documents: an overall quality document and a separate guidance each for Human …

Category: Health Go Health

Digital Therapeutics

WebKaiku Health – app to improve the quality of life for cancer patients (2,14) Nerivio – wireless wearable remote electrical neuromodulation unit controlled by a phone …

Category: Cancer Go Health

Real-World Data/Evidence – increasing use in Healthcare for

WebHealth Canada also provides the requirements in the document, Optimizing the Use of Real World Evidence to Inform Regulatory Decision-Making that sponsors …

Category: Health Go Health

Health Canada Update on Investigational Testing Authorizations

WebInvestigational Testing Authorization (ITA) issued by Health Canada, allows for the testing of Class II, III, and IV medical devices with human subjects. For …

Category: Medical Go Health

Health Canada Regulatory and Clinical Modernization …

WebHealth Canada Regulatory and Clinical Modernization Initiatives Virtual Workshops. Details Download to Calendar Speakers / Panelists Downloads Sponsors. …

Category: Health Go Health

Health Canada Notice on ICH Q3D (R1) the Guideline for

WebPublished on July 3, 2019. By: Pinky Mazumder. On May 31st, 2019, Health Canada issued a Notice titled the Release of the Finalised Guideline for ICH Q3D (R1): Guideline for …

Category: Health Go Health

Clinical Trial Regulatory Activities in eCTD

WebAuthor: Preetha Prabhu. On February 19, 2020, Health Canada announced that the pilot for Clinical Trial regulatory activities in electronic Common Technical …

Category: Health Go Health

Health Canada’s guidance on Fees for Review of Submissions

WebOnce Health Canada screens the submission and informs the sponsor that the submission can progress for review, the sponsor is required to pay 75% of the fee. …

Category: Health Go Health

3D Printing Our Way To Better Health Care

WebIn health care, there is great interest in 3D printing as a tool that can help clinicians, health care administrators, and device manufacturers to visualize and plan …

Category: Health Go Health

HC-HTA Alignment

WebHC and HTAs will monitor and adjust the aligned review process as needed to ensure that it provides benefits to HC, HTAs, and industry. They will also ensure the process supports …

Category: Health Go Health

REGULATORY INTELLIGENCE: STAYING CURRENT IN AN …

WebRegulatory Intelligence is the act of gathering and analyzing publicly available regulatory information. This includes communicating the implications of that information, and …

Category: Health Go Health

Post-NOC Level III Change Updates

WebPost-NOC Level III Change Updates. Published on January 7, 2019. Author: Karen Zhou. A post-NOC change is any change made to a new drug that has received a …

Category: Health Go Health

An update from NNHPD – Release of new web PLA form version 4

WebIt is designed to be completed online and saved at any time to your workstation. Through an active internet connection, the web PLA form searches and …

Category: Health Go Health

Drug Establishment Licensing: An Industry Perspective

WebDEL management. The tracker Innomar uses is a simple Excel spreadsheet with data for approx. 25 information types. There are built in formulas to warn when sites are expiring …

Category: Health Go Health

Regulatory Oversight of Health Product Advertising in Canada …

Web2 Purpose • To provide an overview of the regulatory oversight of health product advertising in Canada. • To discuss the applicability of the current health product advertising …

Category: Health Go Health

Overview of Revised Draft Quality Guidance for Clinical Trial

WebInformation regarding the compatibility of the container closure system (including all drug delivery components, i.e. PVC tubing for infusion kits) with the drug product should be …

Category: Health Go Health

Labelling Symposium with Health Canada

WebRegistration is open from November 3rd to December 2nd, 2021. Clickhere for the brochure (revised December 2, 2021). The CAPRA Symposium Committee will host …

Category: Health Go Health

Health Products Inspection & Licensing (HPIL) Updates

WebDEL and GMP Implementation Periods. May 17, 2018. July 17, 2019. If you conduct activities prior to May 17, 2018 you may continue to do so – you must submit an …

Category: Health Go Health

Health Canada: Guideline for Residual Solvents

WebHealth Canada recently announced the implementation of the ICH Guidance “Q3C(R6) Impurities: Guideline for Residual Solvents” (the “Guidance”) The Guidance …

Category: Health Go Health

Canadian Drug Establishment Licences: GMP Requirements for API …

WebThis API program was implemented for 3 years and it came into full effect on November 08, 2016. On July 31, 2016, Health Canada did publish a “Notice to …

Category: Health Go Health

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