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Core Data Elements for Pregnancy Pharmacovigilance Studies Using Primary Source Data Collection Methods: Recommendations from the IMI ConcePTION Project.
Richardson, Jonathan L; Moore, Alan; Bromley, Rebecca L; Stellfeld, Michael; Geissbühler, Yvonne; Bluett-Duncan, Matthew; Winterfeld, Ursula; Favre, Guillaume; Alexe, Amalia; Oliver, Alison M; van Rijt-Weetink, Yrea R J; Hodson, Kenneth K; Rezaallah, Bita; van Puijenbroek, Eugene P; Lewis, David J; Yates, Laura M.
Afiliação
  • Richardson JL; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK. jonathan.richardson3@nhs.net.
  • Moore A; Institute of Health and Society, Newcastle University, Newcastle upon Tyne, UK. jonathan.richardson3@nhs.net.
  • Bromley RL; Quantitative Safety and Epidemiology, Novartis Pharma AG, 4002, Basel, Switzerland.
  • Stellfeld M; Division of Neuroscience, University of Manchester, Manchester, UK.
  • Geissbühler Y; Royal Manchester Children's Hospital, Oxford Road, Manchester, UK.
  • Bluett-Duncan M; Novo Nordisk A/S, Søborg, Denmark.
  • Winterfeld U; Evidence and Launch Excellence, Novartis Pharma AG, 4002, Basel, Switzerland.
  • Favre G; Division of Neuroscience, University of Manchester, Manchester, UK.
  • Alexe A; Swiss Teratology Information Service and Clinical Pharmacology Service, University Hospital, Lausanne, Switzerland.
  • Oliver AM; Swiss Teratology Information Service and Clinical Pharmacology Service, University Hospital, Lausanne, Switzerland.
  • van Rijt-Weetink YRJ; QPPV and PRRC Office, Novartis Pharma AG, 4002, Basel, Switzerland.
  • Hodson KK; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK.
  • Rezaallah B; Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
  • van Puijenbroek EP; UK Teratology Information Service, The Regional Drug and Therapeutics Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust, 16/17 Framlington Place, Newcastle upon Tyne, NE2 4AB, Tyne and Wear, UK.
  • Lewis DJ; Chief Medical Office and Patient Safety, Novartis Pharma AG, 4002, Basel, Switzerland.
  • Yates LM; Pharmacovigilance Centre Lareb, 's-Hertogenbosch, The Netherlands.
Drug Saf ; 46(5): 479-491, 2023 05.
Article em En | MEDLINE | ID: mdl-36976447

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pesquisa Biomédica / Farmacovigilância Idioma: En Ano de publicação: 2023 Tipo de documento: Article

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Pesquisa Biomédica / Farmacovigilância Idioma: En Ano de publicação: 2023 Tipo de documento: Article