Health Canada PRCI Guiding Principles and Observations

Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to m ...

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Summary of Health Canada’s Public Release of Clinical Information Initiative

Health Canada released guidance on March 12, 2019 pertaining to its Public Release of Clinical Information (PRCI) initiative. Health Canada’s objective with this initiative is to make anonymized clinical information in drug submissions and medical device applications publicly available for non-commercial purposes to enable re-analyses of data, foster new research questions, and help Canadians to m ...

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EMA Policy 0070 External Guidance Update

Even though the European Medicines Agency (EMA) has suspended publication of clinical data through Policy 0070 due to its Brexit business continuity plan, EMA posted a Policy 0070 external guidance update on November 11, 2018. Revision 4 is now in effect. Policy 0070 External Guidance Update - Major Changes Several major changes are noted in this “Summary of Changes” document, including: Cl ...

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We Checked EPARs for Personal Data and Found It

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure What started as research on a European public assessment report (EPAR) on the European Medicines Agency (EMA) website for a sponsor, quickly turned in to a wide spread transparency and disclosure health and wellness check. With the General Data Protection Regulation (GDPR) in effect, knowing exactly what documents are posted pu ...

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