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Stay on top of Human Pharmacovigilance requirements with our monthly Regulatory Intelligence Reports.

Latest report   July 2022

Safety Observer 191

The EMA has published a list of metadata describing Real-World Data (RWD) sources and studies.

Released 08-Jul-2022

Pages 34
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Past Reports

The ANSM has published a revised version of the French Good Pharmacovigilance Practices.
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The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports.
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The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).
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3-Month Plan

This Plan includes three consecutive reports starting with the next release. The perfect solution to test the value of our service.

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1-Year Plan

This Plan includes eleven consecutive reports starting with the next release. Includes a double issue for July/August.

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