c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper-Reference-Cited by-同舟云学术

c4c: Paediatric pharmacovigilance: Methodological considerations in research and development of medicines for children – A c4c expert group white paper

Published:2021-12-18 Issue: Volume: Page:
ISSN:0306-5251
Container-title:British Journal of Clinical Pharmacology
language:en
Short-container-title:Brit J Clinical Pharma

Author:

Aurich Beate¹^ORCID,Apele‐Freimane Dina²^ORCID,Banaschewski Tobias³^ORCID,Chouchana Laurent⁴^ORCID,Day Simon⁵,Kaguelidou Florentia⁶,Kelly Lauren E.⁷^ORCID,Kindblom Jenny M.⁸^ORCID,Neubert Antje⁹^ORCID,Wong Ian C. K.¹⁰¹¹

Affiliation:

1. Department of Pharmacology Saint‐Louis Hospital Paris France

2. Neonatal Intensive Care, Women and Child Health Clinic Pauls Stradins Clinical University Hospital Riga Latvia

3. Department of Child and Adolescent Psychiatry, Central Institute of Mental Health, Medical Faculty Mannheim University of Heidelberg Mannheim Germany

4. Regional Center of Pharmacovigilance, Department of Pharmacology Cochin Hospital, APHP, Centre, Université de Paris Paris France

5. Clinical Trials Consulting and Training Limited North Marston UK

6. Department of Pediatric Pharmacology and Pharmacogenetics, APHP, Robert Debré Hospital; Center of Clinical Investigations, INSERM CIC1426 Université de Paris Paris France

7. Department of Paediatrics and Child Health, Max Rady College of Medicine University of Manitoba Winnipeg Canada

8. Paediatric Clinical Research Center, Queen Silvia Children's Hospital Sahlgrenska University Hospital Gothenburg Sweden

9. Department of Paediatrics and Adolescent Medicine University Hospital Erlangen, Friedrich‐Alexander University Erlangen‐Nürnberg (FAU) Erlangen Germany

10. Centre for Safe Medication Practice and Research, Department of Pharmacology and Pharmacy, Li Ka Shing Faculty of Medicine The University of Hong Kong China

11. Research Department of Practice and Policy, School of Pharmacy UCL London UK

Publisher

Wiley

Subject

Pharmacology (medical),Pharmacology

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/bcp.15119

Reference145 articles.

1. World Health Organisation.Pharmacovigilance.2018.https://www.who.int/medicines/areas/quality_safety/safety_efficacy/pharmvigi/en/. Accessed August 11 2020.

2. Council for International Organizations of Medical Sciences.Practical aspects of signal detection in pharmacovigilance – Report of CIOMS Working group VIII. Geneva 2010.https://cioms.ch/working_groups/working-group-viii/. Accessed August 28 2020.

3. European Medicines Agency. Guidelines on Good Pharmacovigilance Practices (GVP)—Introductory Cover Note Last Updated with Chapter P.III on Pharmacovigilance for the Use of Medicines by Pregnant and Breastfeeding Women. 2019.https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guidelines-good-pharmacovigilance-practices-gvp-introductory-cover-note-last-updated-chapter-piii_en.pdf. Accessed August 17 2020.

4. European Medicines Agency The European Network of Centres for Pharmacoepidemiology and Pharmacovigilance. Guide on Methodological Standards in Pharmacoepidemiology (Revision 8) EMA/95098/2010 Rev.8 2010.http://www.encepp.eu/standards_and_guidances/documents/GuideMethodRev8.pdf. Accessed August 3 2020.

5. Drug toxicity and adverse drug reactions in children—a brief historical review;Choonara I;Paediatr Perinatal Drug Ther,2002

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