Literature DB >> 24751815

Proactively managing the risk of marketed drugs: experience with the EMA Pharmacovigilance Risk Assessment Committee.

Peter Arlett1, Geraldine Portier1, Roberto de Lisa1, Kevin Blake1, Noel Wathion1, Jean-Michel Dogne2, Almath Spooner3, June Raine4, Guido Rasi1.   

Abstract

Mesh：

Year:  2014        PMID： 24751815     DOI： 10.1038/nrd3713-c1

Source DB:  PubMed          Journal:  Nat Rev Drug Discov        ISSN： 1474-1776            Impact factor:   84.694


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  13 in total

1.  A description of signals during the first 18 months of the EMA pharmacovigilance risk assessment committee.

Authors:  Alexandra C Pacurariu; Preciosa M Coloma; Anja van Haren; Georgy Genov; Miriam C J M Sturkenboom; Sabine M J M Straus
Journal:  Drug Saf       Date:  2014-12       Impact factor: 5.606

2.  The US Food and Drug Administration-European Medicines Agency collaboration in pharmacovigilance: common objectives and common challenges.

Authors:  Gerald J Dal Pan; Peter R Arlett
Journal:  Drug Saf       Date:  2015-01       Impact factor: 5.606

3.  Lessons learned on the design and the conduct of Post-Authorization Safety Studies: review of 3 years of PRAC oversight.

Authors:  Pierre Engel; Mariana Ferreira Almas; Marieke Louise De Bruin; Kathryn Starzyk; Stella Blackburn; Nancy Ann Dreyer
Journal:  Br J Clin Pharmacol       Date:  2016-12-07       Impact factor: 4.335

4.  Measuring the impact of risk communications: Robust analytical approaches are key.

Authors:  Peter Arlett
Journal:  Br J Clin Pharmacol       Date:  2020-02-16       Impact factor: 4.335

5.  CD40-mediated signalling influences trafficking, T-cell receptor expression, and T-cell pathogenesis, in the NOD model of type 1 diabetes.

Authors:  Gisela M Vaitaitis; Dan M Waid; Martin G Yussman; David H Wagner
Journal:  Immunology       Date:  2017-06-19       Impact factor: 7.397

6.  Data Rich, Information Poor: Can We Use Electronic Health Records to Create a Learning Healthcare System for Pharmaceuticals?

Authors:  Hans-Georg Eichler; Brigitte Bloechl-Daum; Karl Broich; Paul Alexander Kyrle; Jillian Oderkirk; Guido Rasi; Rui Santos Ivo; Ad Schuurman; Thomas Senderovitz; Luke Slawomirski; Martin Wenzl; Valerie Paris
Journal:  Clin Pharmacol Ther       Date:  2018-10-14       Impact factor: 6.875

7.  Registries supporting new drug applications.

Authors:  Carla J Jonker; H Marijke van den Berg; Marcel S G Kwa; Arno W Hoes; Peter G M Mol
Journal:  Pharmacoepidemiol Drug Saf       Date:  2017-10-06       Impact factor: 2.890

8.  Measuring the impact of medicines regulatory interventions - Systematic review and methodological considerations.

Authors:  Thomas Goedecke; Daniel R Morales; Alexandra Pacurariu; Xavier Kurz
Journal:  Br J Clin Pharmacol       Date:  2017-12-20       Impact factor: 4.335

9.  Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands.

Authors:  Esther de Vries; Petra Denig; Sieta T de Vries; Taco B M Monster; Jacqueline G Hugtenburg; Peter G M Mol
Journal:  Drug Saf       Date:  2020-07       Impact factor: 5.606

Review 10.  Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model.

Authors:  Rona Gini; Miriam C J Sturkenboom; Janet Sultana; Alison Cave; Annalisa Landi; Alexandra Pacurariu; Giuseppe Roberto; Tania Schink; Gianmario Candore; Jim Slattery; Gianluca Trifirò
Journal:  Clin Pharmacol Ther       Date:  2020-05-05       Impact factor: 6.875
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