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

Latest report   May 2022

Safety Observer 189

The FDA published the final guidance for the electronic submission of Postmarketing Safety Reports.

Released 09-May-2022

Pages 31
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Past Reports

The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).
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The EMA has revised its RMP guidance for COVID-19 vaccines with updated requirements for Summary Safety Reports.
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February 2022
Safety Observer 186
The new EU Clinical Trial Regulation became applicable as the CTIS went live on 31-Jan-2022.
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