Georgy Genov
Overview
Explore the profile of Georgy Genov including associated specialties, affiliations and a list of published articles.
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Articles
13
Citations
207
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0
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Recent Articles
1.
Bahri P, Genov G, Arlett P, Sarinic V, Korakianiti E, Nolte A, et al.
Drug Saf
. 2024 Jul;
47(10):941-956.
PMID: 38987419
This article reflects on the 2010 pharmacovigilance legislation of the European Union (EU). Its legislative aim of better patient and public health protection through new responsibilities for pharmaceutical companies and...
2.
Buoninfante A, Andeweg A, Genov G, Cavaleri M
NPJ Vaccines
. 2024 Jun;
9(1):122.
PMID: 38942751
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...
3.
Gordillo-Maranon M, Szmigiel A, Yalmanova V, Caplanusi I, Genov G, Olsen D, et al.
Drug Saf
. 2024 Apr;
47(8):783-798.
PMID: 38607521
Background And Objective: During the COVID-19 vaccination campaign, over 34,000 reports of heavy menstrual bleeding following the administration of COVID-19 vaccines originating in the Economic European Area were submitted to...
4.
Caplanusi I, Szmigiel A, van der Elst M, Schougaard Christiansen M, Thirstrup S, Zaccaria C, et al.
Drug Saf
. 2024 Feb;
47(5):405-418.
PMID: 38396269
The European Union (EU) regulatory network was at the forefront of the safety monitoring of COVID-19 vaccines during the pandemic. An unprecedented number of case reports of suspected adverse reactions...
5.
Durand J, Dogne J, Cohet C, Browne K, Gordillo-Maranon M, Piccolo L, et al.
Clin Pharmacol Ther
. 2022 Dec;
113(6):1223-1234.
PMID: 36524423
Prior to deployment of coronavirus disease 2019 (COVID-19) vaccines in the European Union in 2021, a high vaccine uptake leading to an unprecedented volume of safety data from spontaneous reports...
6.
Januskiene J, Segec A, Slattery J, Genov G, Plueschke K, Kurz X, et al.
Pharmacoepidemiol Drug Saf
. 2020 Oct;
30(3):334-341.
PMID: 33099846
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...
7.
Potts J, Genov G, Segec A, Raine J, Straus S, Arlett P
Clin Pharmacol Ther
. 2019 Oct;
107(3):521-529.
PMID: 31621897
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...
8.
Pacurariu A, Hoeve C, Arlett P, Genov G, Slattery J, Sturkenboom M, et al.
Pharmacoepidemiol Drug Saf
. 2017 Dec;
27(2):168-173.
PMID: 29278866
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...
9.
Santoro A, Genov G, Spooner A, Raine J, Arlett P
Drug Saf
. 2017 Jul;
40(10):855-869.
PMID: 28735357
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...
10.
Banovac M, Candore G, Slattery J, Houyez F, Haerry D, Genov G, et al.
Drug Saf
. 2017 Apr;
40(7):629-645.
PMID: 28417320
Introduction: 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...