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

Latest report   November 2021

Safety Observer 183

The EMA has published the CTIS go-live plan and calls all users to prepare for the launch in January 2022.

Released 10-Nov-2021

Pages 17
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Past Reports

Highlights include the new FDA draft guidance on safety reporting requirements for trial investigators.
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September 2021
Safety Observer 181
Countdown officially started ! The EU Clinical Trials Regulation will enter into force on 31-Jan-2022.
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Highlights
Top stories include: PSURs for COVID-19 Vaccines & New DSUR requirements in the UK and Canada.
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