Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports-Reference-Cited by-同舟云学术

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Aggregate analysis of regulatory authority assessors' comments to improve the quality of periodic safety update reports

Published:2015-07-14 Issue:9 Volume:24 Page:971-979
ISSN:1053-8569
Container-title:Pharmacoepidemiology and Drug Safety
language:en
Short-container-title:Pharmacoepidemiol Drug Saf

Author:

Jullian Sandra¹^ORCID,Jaskiewicz Lukasz¹,Pfannkuche Hans-Jürgen¹,Parker Jeremy¹,Lalande-Luesink Isabelle¹,Lewis David J.¹²,Close Philippe³⁴

Affiliation:

1. Drug Safety and Epidemiology; Novartis Pharma AG; Basel Switzerland

2. School of Life and Medical Sciences; University of Hertfordshire; Hatfield England

3. European Qualified Person for Pharmacovigilance; Novartis Pharma Produktions GmbH; Wehr Germany

4. Chief Medical Office; Novartis Pharma AG; Basel Switzerland

Publisher

Wiley

Subject

Pharmacology (medical),Epidemiology

Link

http://onlinelibrary.wiley.com/wol1/doi/10.1002/pds.3818/fullpdf

Reference13 articles.

1. European Medicines Agency Guideline on good pharmacovigilance practices (GVP) 2012

2. European Medicines Agency Guideline on good pharmacovigilance practices (GVP) 2013

3. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 2014

4. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use 2012

5. International Reporting of Periodic Drug-Safety Update Summaries Final report of CIOMS working group II 1992

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