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Past Reports
April 2022
Safety Observer 188The EMA started a new consultation on the draft GVP Addendum that covers Pregnancy Prevention Programmes (PPP).
March 2022
Safety Observer 187The EMA has revised its RMP guidance for COVID-19 vaccines with updated requirements for Summary Safety Reports.
February 2022
Safety Observer 186The new EU Clinical Trial Regulation became applicable as the CTIS went live on 31-Jan-2022.
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Latest news

- February 7, 2022
MHRA & GPvP Inspections
- By Thierry Hamard

- May 9, 2022
COVID-19 Guidance & Updates
- By Thierry Hamard

- March 7, 2021
RSI in Clinical Trials: MHRA Findings and Tips
- By Thierry Hamard

- November 18, 2020
Risk Management & COVID-19 vaccines
- By Thierry Hamard

- May 20, 2020
FDA Guidance on AE Reporting during a Pandemic
- By Thierry Hamard
Supporting the global Pharmacovigilance community since 2005
We are proud to serve pharmacovigilance professionals in more than 100 organisations across the world, including major pharma corporations, small biotech, service providers, and public hospitals.