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Tag Archives: Health Canada
Health Canada Increases Acceptance of eCTD Electronic-only Filings
Late last week, Health Canada (HC) announced that it is further expanding its acceptance of regulatory submissions in the eCTD electronic-only format. In addition the submission types already accepted in eCTD electronic-only format (including those added to the list earlier … Continue reading
Choose Canada for Your Next Clinical Trial
When it comes to the state of the life science industry in Canada, the critics are numerous. The past two to three years have been difficult and those that lie ahead are still quite uncertain. With the growing competition at … Continue reading
Posted in Clinical Trials, Health Canada
Tagged Canada, clinical research, clinical trials, CTA, Electronic data capture, enrollment, GCP, Health Canada, patient recruitment, tax credit
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Clinical Study Reports to STFs
When working with sponsors who are new to eCTD submissions, one of the most common questions we get is, “What is a Study Tagging File and why do we need one for each clinical study report?” To explain the importance … Continue reading
Posted in eCTD, FDA, Guest Posts
Tagged clinical study report, eCTD, EMA, FDA, GlobalSubmit, Health Canada, Japan, STF, study tagging files
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Health Canada Expands Acceptance of eCTD Submissions
Image via cellularhealthcanada.com Last week, Health Canada (HC) issued a Notice to to announce an increase in the types of submissions being accepted by the regulatory authority in the eCTD electronic-only filing format. Effective immediately, HC now also accepts two … Continue reading
Download the Regulatory Compliance Webinar Slides
Earlier today, Cato Research hosted a webinar titled, “Regulatory Affairs and Compliance: Common Sources of Deficiencies Identified by the Regulatory Authorities in the United States and Canada.” For those of you who are interested, the slides from Dr. Sheppard‘s presentation … Continue reading
Posted in FDA, Health Canada, Regulatory Strategy, Webinars
Tagged FDA, Health Canada, webinar
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