WebSep 24, 2024 · On 24 September 2024 the EMA issued the draft guideline on registry-based studies. A registry-based study is an investigation of a research question using the infrastructure of (a) new or (an) existing registry(ies) for patient recruitment and data collection. A registry-based study may be a clinical trial, to which the provisions of … WebThe European Medicines Agency ( EMA) has released new guidelines for using and generating RWE in registry-based studies. The guideline highlighted a commitment to avoiding bias resulting from non-randomized studies through responsible database usage.

Comments form_Guideline on registry-based studies - EFPIA

WebInternational scientific guideline: Guideline on registry-based studies EMA/426390/2024 adopted by the Therapeutic Goods Administration (TGA) About this guideline TGA adopted date: 11 Nov 2024 Overseas effective date: 16 Sep 2024 Categories: Pharmacovigilance Access this international scientific guideline TGA annotations WebThe general principles of this guideline are adopted. Sponsors should refer to the TGA pharmacovigilance guidelines Pharmacovigilance responsibilities of medicine sponsors … can a school be a charity

EMA Issues Guideline on RWE in Registry-Based Studies

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