Clarifying Health Canada’s Public Release of Clinical Information Draft Guidance – Part II

Last week we shared Part I of our three-part series on the questions and clarifications we submitted to Health Canada regarding their draft guidance on the Public Release of Clinical Information. Many thanks to everyone who commented with their insight. Following is Part II. Please leave your comments below to keep the conversation going. Health Canada's Public Release of Clinical Information: Ou ...

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Questions Regarding the Public Release of Clinical Information Draft Guidance – Part I

Synchrogenix’s experts and thought leaders have a pulse on the future impact of decisions made today, which is why we offer comments on global draft guidances on behalf of life science companies worldwide. Nirpal Virdee, Synchrogenix's Director of Client Services and Technology, recently submitted feedback to Health Canada regarding their draft guidance on the Public Release of Clinical Informatio ...

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EMA’s Implementation of Policy 0070: Highlights From Year One

The European Medicines Agency (EMA) published its first report on the implementation of Policy 0070 for the publication of clinical data. As of October 2016, the EMA publishes clinical data submitted by pharmaceutical companies to support their regulatory applications for human medicines under the centralized procedure. The 27-page report, published July 16, 2018, covers one year from the launch o ...

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