Safety Reporting for Auxiliary Medicinal Products in the SibeprenlimabPhase-III Study According to the New European Union (536/2014) CTRegulation
From the gap analysis and impact assessment of EU CTR, appropriate changes were made to the existing PV processes, study-specific documents, and the safety database to ensure compliance with the EU CTR.
Authors
- Vinu George
- C. J. Sheppard (ORCID: https://orcid.org/0000-0002-3699-4970)
- Meijun Huang
- Nipa Parikh
- Varsha Khare (ORCID: https://orcid.org/0000-0003-1602-1255)
- Paritosh Giri (ORCID: https://orcid.org/0000-0001-9994-3698)
- Retesh Kumar
Institutions
- Otsuka (United States) (US)
- Otsuka Pharmaceutical (Spain) (ES)
- Otsuka (United Kingdom) (GB)
- Otsuka (Germany) (DE)
Publication Details
- Journal
- Current Drug Safety
- Published
- 2025-04-29
- DOI
- https://doi.org/10.2174/0115748863329287250411114336
- Primary Topic
- Health Systems, Economic Evaluations, Quality of Life
- Type
- article
- Field-Weighted Citation Impact
- 0.00