İlko Getov
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View article: Non-interventional pharmacovigilance studies - an analysis of real-world data sources in the HMA-EMA catalogs
Non-interventional pharmacovigilance studies - an analysis of real-world data sources in the HMA-EMA catalogs Open
Real-world data catalogs established by the Heads of Medicines Agencies and the European Medicines Agency (HMA–EMA RWD catalogues) represent a centralized digital approach for broad access to reliable data to ensure patient safety. In this…
View article: In situ development of an artificial intelligence (AI) model for early detection of adverse drug reactions (ADRs) to ensure drug safety
In situ development of an artificial intelligence (AI) model for early detection of adverse drug reactions (ADRs) to ensure drug safety Open
Pharmacovigilance is a vital component of public health systems, aiming to ensure the safe use of medicinal products. In this study, an artificial intelligence (AI)-based model was developed using TensorFlow to predict the likelihood of ad…
View article: Drug repurposing for inclusion of COVID-19-related indication: field study of the European Medicines Agency’s response to the pandemic
Drug repurposing for inclusion of COVID-19-related indication: field study of the European Medicines Agency’s response to the pandemic Open
As one of the biggest challenges for healthcare in the 21st century, COVID-19 placed a sustained and intense demand on the European Medicines Agency resources and required constant adaptation and mobilization of different regulatory proces…
View article: Opportunities for implementing digital applications to monitor the impact of risk-minimization measures within the pharmacovigilance process: Scoping review of published literature
Opportunities for implementing digital applications to monitor the impact of risk-minimization measures within the pharmacovigilance process: Scoping review of published literature Open
The study provides an overview of innovative digital solutions to meet the evolving needs of drug safety monitoring and improve patient outcomes, focusing on implementing digital applications to enhance the monitoring of additional risk-mi…
View article: Research and analysis of regulatory framework and harmonisation of repurposing
Research and analysis of regulatory framework and harmonisation of repurposing Open
Drug repurposing is a modern and successful mechanism for discovering new therapeutic indications for authorised medicinal products. There is an absence of a clear definition of the term “drug repurposing” or its synonyms in regulatory fra…
View article: Research and pilot analysis of <i>bevacizumab</i> repurposing potential and its impact in clinical practice
Research and pilot analysis of <i>bevacizumab</i> repurposing potential and its impact in clinical practice Open
Repurposing of drugs is a strategy for discovering new uses for already authorized or tested medicines outside their original indications. Bevacizumab is humanized antibody, observed to have anti-VEGF (Vascular Endothelial Growth Factor) e…
View article: Exploring Drug Repositioning: A Comprehensive Review Of Clinical, Regulatory, And Marketing Strategies
Exploring Drug Repositioning: A Comprehensive Review Of Clinical, Regulatory, And Marketing Strategies Open
Drug repositioning, a widely adopted strategy, involves the exploration of new indications for investigational or already authorized medicinal products. This approach leverages clinical, regulatory, and marketing tactics to expand a drug's…
View article: Awareness of healthcare professionals about risk minimization measures associated with COVID-19 vaccines: international cross-sectional study
Awareness of healthcare professionals about risk minimization measures associated with COVID-19 vaccines: international cross-sectional study Open
The Coronavirus 2019 (COVID-19) pandemic caused the global healthcare to face one of the most significant challenges since the World Health Organization was founded over 70 years ago. The development and approval of marketing authorization…
View article: Marketing authorization procedures with negative opinion from EMA—tendencies and novelties in 2021–2022
Marketing authorization procedures with negative opinion from EMA—tendencies and novelties in 2021–2022 Open
Every year the European Medicines Agency conducts scientific assessment of numerous applications for marketing authorization of new medicines via centralized procedure. Relatively few of them are being rejected yearly because of insufficie…
View article: Analysis of marketing authorization procedures with negative opinion 2020-2021 – how EMA handled challenges in drug therapy during Covid-19 pandemic
Analysis of marketing authorization procedures with negative opinion 2020-2021 – how EMA handled challenges in drug therapy during Covid-19 pandemic Open
Every year the European medicines agency assesses numerous applications for marketing authorization of new medicines with a part of them inevitably being rejected. For the period 2020-July 2021 less than 5% of the marketing authorization a…
View article: Medicine packaging pictograms in the context of the electronic product information (ePI) proposal
Medicine packaging pictograms in the context of the electronic product information (ePI) proposal Open
Contemporary drug regulations and pharmacovigilance have to search constantly for innovative ways to improve the quality of drug safety information offered to the public, patients and medical specialists. The problem of reliability of info…
View article: In-depth Assessment after 18 Months of Distance E-learning of Pharmacists in Bulgaria
In-depth Assessment after 18 Months of Distance E-learning of Pharmacists in Bulgaria Open
Continuous Professional Development (CPD) is an essential part of the professional development process of each pharmacist. As CPD helps pharmacists to improve their work quality and to become more useful for their patients the Bulgarian Ph…
View article: Physician's knowledge and experience with the off-label use of medicines
Physician's knowledge and experience with the off-label use of medicines Open
The off-label use of medicines is neither prohibited nor explicitly allowed, according to the current European Union (EU) pharmaceutical legislation. This can cause confusion in physicians’ practice as well as lead to patients’ dissatisfac…
View article: What does self-medication counseling in Bulgarian community pharmacies look like – a field study
What does self-medication counseling in Bulgarian community pharmacies look like – a field study Open
The aim of the study is to identify the current practices of self-medication in Bulgaria, estimate the extent patients are influenced by information about the safety of OTC products and pharmacists’ role and behavior in the process. An ano…
View article: Pilot Study of Pharmacists&rsquo; Attitudes towards and Expectations for Remuneration of Valueadded Pharmacy Services (VAPS) in Bulgaria
Pilot Study of Pharmacists’ Attitudes towards and Expectations for Remuneration of Valueadded Pharmacy Services (VAPS) in Bulgaria Open
Introduction: Value-added pharmacy services (VAPS) are additional services to the traditional pharmacy activities, which do not in­clude dispensing of medicinal products and professional consultation. These services have cost reduction…
View article: Risk-Minimization Measures in the EU: Review of Two Year Period Safety Referral Procedures
Risk-Minimization Measures in the EU: Review of Two Year Period Safety Referral Procedures Open
The current study aims to research, systemize and analyze the qualitative characteristics of pharmacovigilance referral procedures which took place in the EU for two years period 2017-2018.For the purpose of the study PRAC decisions and mi…
View article: The knowledge and experience with the off-label use – results of a survey
The knowledge and experience with the off-label use – results of a survey Open
Introduction : The aim of this survey is to assess the current knowledge and experience of medical doctors in regard to off-label use and to determine whether it is legal, according to them, as the local current legislation on medicinal pr…
View article: Analysis of primary outpatient data for off-label use of medicines in neurology
Analysis of primary outpatient data for off-label use of medicines in neurology Open
Introduction : The off-label use of medicines is a common practice that covers a wide range of therapeutic areas in both, adults and children. So far, the extent of off-label use among neurology patients in Bulgaria has not been studied. T…
View article: Cross-Sectional Analysis of Current State of Arts and Community Pharmacists' Attitudes toward Value-Added Pharmacy Services in Bulgaria
Cross-Sectional Analysis of Current State of Arts and Community Pharmacists' Attitudes toward Value-Added Pharmacy Services in Bulgaria Open
Value-added pharmacy services (VAPS) are not connected with traditional pharmacy activities and do not include services, related to dispensing of medicines and professional consultation.A cross-sectional study that included pharmacists wor…
View article: E-Detailing: Keyways for Successful Implementation of Digital Technologies in the Pharmaceutical Marketing
E-Detailing: Keyways for Successful Implementation of Digital Technologies in the Pharmaceutical Marketing Open
E-detailing describes the use of IT tools for promotional activities—delivering information for pharmaceutical products to customers (health professionals, medical personnel, and patients). It includes using electronic channels to interact…
View article: Evaluation of the current status of the value-added pharmacy services and pharmacists’ attitude in Bulgaria
Evaluation of the current status of the value-added pharmacy services and pharmacists’ attitude in Bulgaria Open
Value-added pharmacy services (VAPS) are additional services to the traditional pharmacy activities, which do not include dispensing of medicinal products and professional consultation. Over 51% of the community pharmacies in Bulgaria offe…
View article: Questionnaire Survey Among Hospital Pharmacists On The Effects Of The Change In The Legislation Regulating Clinical Trials In Bulgaria
Questionnaire Survey Among Hospital Pharmacists On The Effects Of The Change In The Legislation Regulating Clinical Trials In Bulgaria Open
Участието на болничните фармацевти в провеждането на клинични изпитвания е важно, за да се осигури качество и проследимостта при съхранението, разпределянето и отчетността на изпитвания лекарствен продукт (IMP). Задължителен текст, регулир…