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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Brexit Impact on EudraCT Postings

The European Commission published a notice to stakeholders on September 6, reminding pharmaceutical companies of some unexpected impacts of Brexit in multiple areas, including the submission of clinical trial information to EudraCT. The submission of certain clinical trial information to the European Union (EU) database is a provision of an EU law which will no longer apply to the United Kingdom ( ...

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Patient Narratives: Writing Process & Example with Key Components

Patient narratives are brief summaries of specific events experienced by patients during the course of a clinical trial. They are a required component of clinical study reports (CSRs) and pharmacovigilance activities and aid in the evaluation of the safety profile of a drug. Here we will briefly review the narrative writing process and provide a patient narrative example. Patient Narrative Writin ...

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EMA Policy 43: Revised Policy on Access to Documents

By Kristin McDougall, Work Stream Lead, Transparency & Disclosure The European Medicines Agency (EMA) recently placed a new notification on its website revising who can request access to unpublished documents under the scope of Policy 43. EMA Policy 43 pertains to the legal right of access to documents that were sent to the EMA for now-approved medicinal products for human and veterinary use. ...

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Clarifications Concerning Health Canada’s Draft Guidance on the Public Release of Clinical Information – Part III

Over the past two weeks we have shared our questions and clarifications concerning Health Canada's draft guidance on the Public Release of Clinical Information. Following is Part III, which represents the conclusion of this series. Please click here to read Part I. Please click here to read Part II. Clarifications Concerning Health Canada's Draft Guidance on the Public Release of Clinical Informa ...

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