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Risk Management Plans: reassessment of safety concerns based on Good Pharmacovigilance Practices Module V (Revision 2)-a company experience.
Esslinger, Suzan; Quinn, Linda; Sampat, Sami; Otero-Lobato, Marijo; Noël, Wim; Geldhof, Anja; Herijgers, Nicole; Reeder, Sarah-Jane.
Afiliação
  • Esslinger S; Medical Affairs, Cilag GmbH International, Gubelstrasse 34, 6300, Zug, Switzerland. sesslin1@its.jnj.com.
  • Quinn L; Global Medical Safety, Janssen Research & Development, LLC, 850 Ridgeview Drive, Horsham, PA, 19044, USA.
  • Sampat S; Global Medical Safety, Janssen Research & Development, LLC, 850 Ridgeview Drive, Horsham, PA, 19044, USA.
  • Otero-Lobato M; Medical Affairs, Janssen Biologics BV, Einsteinweg 101, 2333 CB, Leiden, The Netherlands.
  • Noël W; EMEA Medical Affairs, Janssen Cilag NV, Turnhoutseweg 30, 2340, Beerse, Belgium.
  • Geldhof A; Medical Affairs, Janssen Biologics BV, Einsteinweg 101, 2333 CB, Leiden, The Netherlands.
  • Herijgers N; EMEA Regulatory Affairs, Janssen Biologics BV, Archimedesweg 29, 2333 CM, Leiden, The Netherlands.
  • Reeder SJ; Global Medical Safety, Janssen-Cilag Ltd., 50-100 Holmers Farm Way, High Wycombe, HP12 4DP, Buckinghamshire, UK.
J Pharm Health Care Sci ; 8(1): 14, 2022 May 05.
Article em En | MEDLINE | ID: mdl-35509028
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Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Tipo de estudo: Etiology_studies / Guideline / Risk_factors_studies Idioma: En Ano de publicação: 2022 Tipo de documento: Article