Zobrazeno 1 - 10
of 12
pro vyhledávání: '"Georgy Genov"'
Publikováno v:
npj Vaccines, Vol 9, Iss 1, Pp 1-8 (2024)
Abstract Following the start of the COVID-19 vaccination campaign, the adverse events of myocarditis and pericarditis were linked mainly to mRNA COVID-19 vaccines by the regulatory authorities worldwide. COVID-19 vaccines have been administered to se
Externí odkaz:
https://doaj.org/article/441fcc7f550349169b1d22b57ac5e1a2
Autor:
Julie Durand, Jean‐Michel Dogné, Catherine Cohet, Kate Browne, María Gordillo‐Marañón, Loris Piccolo, Cosimo Zaccaria, Georgy Genov
Publikováno v:
Clinical pharmacology and therapeutics.
Prior to deployment of COVID-19 vaccines in the European Union (EU) in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports and real-world evidence, was anticipated. The European Medicines Agency (EMA
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1fca05a13e47e3ab840e68a9de24454b
https://pubmed.ncbi.nlm.nih.gov/36524423
https://pubmed.ncbi.nlm.nih.gov/36524423
Autor:
Justina Januskiene, Kelly Plueschke, Andrej Segec, Xavier Kurz, Jim Slattery, Peter Arlett, Georgy Genov
Publikováno v:
Pharmacoepidemiology and Drug Safety
Background The additional monitoring (AM)/black triangle concept is aimed to enhance ADR reporting for certain types of medicinal products for which the safety profile is less well established. Purpose The objective of this survey was to assess (a) a
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1df99944d32964bbde81de3dee3ebe0b
https://doi.org/10.1002/pds.5162
https://doi.org/10.1002/pds.5162
Publikováno v:
Clinical Pharmacology and Therapeutics
Pharmacovigilance and risk minimization must be planned during drug development and forms a critical part of the regulator's decision on whether a medicinal product can be authorized. Pharmacovigilance systems should ensure proactive monitoring of al
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e4f971cd5abaa6717a1cf245524ec9e3
https://doi.org/10.1002/cpt.1678
https://doi.org/10.1002/cpt.1678
Autor:
Miriam C. J. M. Sturkenboom, Alexandra Pacurariu, Christina E. Hoeve, Jim Slattery, Peter Arlett, Georgy Genov, Sabine M. J. M. Straus
Publikováno v:
Pharmacoepidemiology and Drug Safety, 27(2), 168-173. John Wiley & Sons Ltd.
Background: The amount of drug exposure, pre and post approval, is considered to be a direct determinant of knowledge about the safety of a drug. A larger pre-approval exposed population is supposed to reduce the risk of unanticipated safety issues p
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::5fc5fdb89fad741b2f8316a73da8076d
https://hdl.handle.net/1765/103729
https://hdl.handle.net/1765/103729
Publikováno v:
Drug Safety
This article provides an overview of the European Union pharmacovigilance system resulting from the rationalisation and strengthening delivered through the implementation of the revised pharmacovigilance legislation. It outlines the system aims, unde
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::170e44be18a85bd1a103f489a3b0728b
https://doi.org/10.1007/s40264-017-0572-8
https://doi.org/10.1007/s40264-017-0572-8
Autor:
Alex Asiimwe, Alfons Lieftucht, Georgy Genov, Deborah Ashby, Ioanna Tzoulaki, Alain Micaleff, Rebecca Noel, Richard C. Hermann, Ruth Peters, Christine E. Hallgreen, Shahrul Mt-Isa, Gerald Downey, Lawrence D. Phillips, Susan Talbot, Diana Hughes
Publikováno v:
Pharmacoepidemiology and Drug Safety. 25:238-250
Background The PROTECT Benefit–Risk group is dedicated to research in methods for continuous benefit–risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods. Methods A comprehensive
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::858487645ef74921d355cf0e78c76110
https://doi.org/10.1002/pds.3880
https://doi.org/10.1002/pds.3880
Autor:
David Haerry, Peter Arlett, Jim Slattery, Gianmario Candore, François Houÿez, Marin Banovac, Georgy Genov
Publikováno v:
Drug safety. 40(7)
New pharmacovigilance legislation was adopted in the EU in 2010 and became operational in July 2012. The legislation placed an obligation on all national competent authorities (NCAs) and marketing authorisation holders (MAHs) to record and report cas
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_dedup___::13f3376c79cad1912fe4a118c6d5ee61
https://pubmed.ncbi.nlm.nih.gov/28676981
https://pubmed.ncbi.nlm.nih.gov/28676981
Autor:
Stephen F. Hobbiger, Davide Luciani, Christine E. Hallgreen, Shahrul Mt-Isa, Lawrence D. Phillips, George Quartey, Deborah Ashby, Kimberley Hockley, Ian Hirsch, Isabelle Stoeckert, Torbjörn Callréus, Nan Wang, Ioanna Tzoulaki, Georgy Genov, Alain Micaleff, Sinan B. Sarac
Publikováno v:
Pharmacoepidemiology and Drug Safety. 23:667-678
Background The need for formal and structured approaches for benefit-risk assessment of medicines is increasing, as is the complexity of the scientific questions addressed before making decisions on the benefit-risk balance of medicines. We systemati
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::53430245c652da1d9e86ff134e5222d2
https://doi.org/10.1002/pds.3636
https://doi.org/10.1002/pds.3636
Autor:
Christine E, Hallgreen, Shahrul, Mt-Isa, Alfons, Lieftucht, Lawrence D, Phillips, Diana, Hughes, Susan, Talbot, Alex, Asiimwe, Gerald, Downey, Georgy, Genov, Richard, Hermann, Rebecca, Noel, Ruth, Peters, Alain, Micaleff, Ioanna, Tzoulaki, Deborah, Ashby
Publikováno v:
Pharmacoepidemiology and drug safety. 25(3)
The PROTECT Benefit-Risk group is dedicated to research in methods for continuous benefit-risk monitoring of medicines, including the presentation of the results, with a particular emphasis on graphical methods.A comprehensive review was performed to
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=pmid________::9dd7823b01408b820980bcc7e40849a6
https://pubmed.ncbi.nlm.nih.gov/26521865
https://pubmed.ncbi.nlm.nih.gov/26521865