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EMA FAQs How to submit an annual safety report and respond to related RFIs

FAQs
How to submit an annual safety report and respond to related RFIs

CTIS Training Programme – Module 18
Version 1.2 – March 2025

News & Trends

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Recentes

  • EMA Updates Guidance on National Pharmacovigilance Contact Person Requirements
  • ICH E20 draft guideline on adaptive designs in confirmatory clinical trials
  • Critical shortages of medicines. European Court of Auditors’ Special Report
  • EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
  • Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation (IVDR). MEDTECH E-BOOK
  • A Formiventos está novamente no ranking das Top 5% melhores PME de Portugal
  • Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices Version 4 – September 2025
  • ICH adopts M14 guideline on observational studies

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