European Patients Academy on Therapeutic Innovation: Post-Authorisation Efficacy Studies (PAES)
The European Patients Academy on Therapeutic Innovation focuses on PAES to address important questions about medicine efficacy post-authorization. Regulators may request such studies to resolve concerns and ensure the initial evidence for marketing authorization is upheld. PAES can be triggered by N
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Preventable Adverse Event Reporting 2016 Spring Update Summary
Annual Survey process, assessment of harm, reportable PAEs, differences between SREs and HACs, selected Tier 2 and 3 PAEs, 2015 PAE findings, case scenarios/FAQs, Report No. PAEs timeline, available resources on PAE website, upcoming training information, and contact details for questions and suppor
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