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Proceedings of the Fifth Scientific and Practical Conference with international participation “Safety and Legal Support of Medicinal Products: from Development to Medical Use”, dedicated to the memory of Professor Oleksii Pavlovych Viktorov, Doctor of Medical Sciences / Proceedings of the Fifth Scientific and Practical Conference with international participation “Safety and Legal Support of Medicinal Products: from Development to Medical Use” in memory of Oleksii Pavlovych Viktorov, Doctor of Medical Sciences, Professor

07.11.2019 Updated 07.10.2026 7198 views
Plenary session / Plenary session
3S – Smart Safety SurveillancePDF · 1.4 MB
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Current trends in global pharmacovigilancePDF · 3.5 MB
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Patient involvement in drug development and safe usePDF · 1.3 MB
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Pharmacovigilance in Ukraine: achievements and prospectsPDF · 1.6 MB
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Safety issues at the stage of medicinal product development / Safety issues in drug development
Analysis of information on adverse reactions during clinical trialsPDF · 1.6 MB
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Modern approaches to monitoring adverse reactions during clinical trialsPDF · 690 KB
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FACTORS AFFECTING THE SAFETY AND EFFICACY OF MEDICINAL PRODUCTSPDF · 3.1 MB
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Safety of immunoprophylaxis / Safety of immunoprophylaxis
Vaccine Safety Communication – Increasing Trust in VaccinesPDF · 2.3 MB
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Vaccination in various clinical conditions: NITAG recommendationsPDF · 769 KB
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Experience of pharmacovigilance of vaccines in Cherkasy OblastPDF · 1.3 MB
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Risk management system and signal management / Risk management system and signal management
Risk Management Sysetms in PharmacovigilancePDF · 362 KB
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Signals. Risk evaluation and managementPDF · 1.1 MB
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Analysis of risk management plan dataPDF · 709 KB
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Risk minimization in the pharmacovigilance systemPDF · 975 KB
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Risk assessment during clinical trials of medicinal productsPDF · 1.1 MB
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Bioequivalence and drug monitoring / Bioequivalence and drug monitoring
Introducing Internationally accepted Bioequivalence Standards in Ukraine: Strategy and early winsPDF · 673 KB
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International approaches and the role of bioequivalence evidence in forming the list of interchangeable generic medicinal productsPDF · 1.4 MB
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Therapeutic drug monitoring as a tool for improving the safety and effectiveness of treatmentPDF · 1.7 MB
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Registration dossier as a reflection of the life cycle of a medicinal product / Registration dossier as a representation of the life cycle of medicinal product
Expert evaluation of the registration dossier. Risks from reference countries.PDF · 603 KB
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Critical quality attributes and their potential impact on the safety of a medicinal productPDF · 1.1 MB
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Updating information in the instructions for medical use: grounds and definition of the procedurePDF · 1.1 MB
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Pharmaceutical development as a guarantee of the quality and safety of a medicinal productPDF · 2.7 MB
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Initiation of procedures based on the results of the assessment of medicinal product safety dataPDF · 1.7 MB
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Pharmacovigilance / Pharmacovigilance
Current issues of pharmacovigilance in UkrainePDF · 1.9 MB
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Successes and challenges of pharmacovigilance in Kharkiv OblastPDF · 938 KB
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PHARMACOVIGILANCE realities of todayPDF · 9.8 MB
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Clinical safety: information and clinical data management / Clinical safety: information and clinical data management
VigiBase analysisPDF · 2 MB
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Formulary system for the provision of medicinal products – adequacy to the demands of the time and the realities of the country of implementation / Formulary system’s role in improving access to medicinal products - Response to the current needs in the implementing country
State Formulary of Medicinal Products and Health Technology AssessmentPDF · 3.1 MB
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Formulary system: problems and prospects in UkrainePDF · 843 KB
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Main components and results of monitoring and evaluating the performance of the formulary system in UkrainePDF · 1.4 MB
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THE FORMULARY SYSTEM FROM THE POINT OF VIEW OF A PRACTICING PHYSICIANPDF · 2.3 MB
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Biosimilars – products of the future: regulatory issues and pharmacovigilance / Biosimilars – products of the future: regulatory issues and pharmacovigilance
Quality issues of biological/biotechnological medicinal products and immunogenicityPDF · 2.1 MB
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IMMUNOGENICITY AND BIOLOGICAL PRODUCTSPDF · 2.3 MB
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Regulation of circulation and pharmacovigilance in the CIS countries / Medicines regulation and pharmacovigilance in CIS countries
How to improve communication in Pharmacovigilance?PDF · 1.8 MB
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The priorities in pharmacovigilance system in the Republic of MoldovaPDF · 2.5 MB
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REGISTRATION AND CERTIFICATION OF MEDICINAL PRODUCTS, MEDICAL DEVICES, AND MEDICAL EQUIPMENT IN THE REPUBLIC OF UZBEKISTANPDF · 2.3 MB
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The pharmacovigilance system in the Republic of UzbekistanPDF · 1.9 MB
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National List of Essential Medicines as a guarantee of free basic treatment for citizens of Ukraine / National list of essential medicines as a guarantee of basic free medical care for Ukrainian citizens
National List of Essential Medicines. Principles of creation and expansionPDF · 1.9 MB
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Health technology assessment: the main tool for including medicinal products in the National ListPDF · 1.8 MB
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List of priority diseases in Ukraine: methodology and resultsPDF · 5.2 MB
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Post-registration safety and efficacy studies of medicinal products / Post-registration safety and efficacy studies of MP
Advantages and challenges of post-marketing studiesPDF · 1 MB
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Non-interventional clinical trials: procedure for conducting and prospects for development in UkrainePDF · 786 KB
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Round table “Round table “Regulatory issues and communications in the context of pharmacovigilance” / Round table “Regulatory issues and communications in pharmacovigilance”
Information exchange in pharmacovigilance. Help or obstaclePDF · 1.3 MB
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Health technology assessment – a new decision-making tool / Health technology assessment - a new decision making tool
European Network for Health Technology AssessmentPDF · 620 KB
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Implementation of the HTA methodology in accordance with the best international practicePDF · 1.4 MB
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Building human capacity in the field of health technology assessment in UkrainePDF · 4.2 MB
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The role of health technology assessment in decision-making in the healthcare system of Ukraine based on the highest value for patients: a roadmapPDF · 2.2 MB
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Useful resources
Conferences, Forums, Events
Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"
Forum "PHARMEXPERT 2026: pharmaceutical market in the new regulatory reality"
Forum "Clinical and preclinical studies in wartime: organization and development prospects"
Forum "Clinical and preclinical studies in wartime: organization and development prospects"
Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"
Pharmaceutical forum "PHARMEXPERT 2025. eCTD and pricing in Ukraine – a strategic path to integration into the international regulatory space"
PHARMEXPERT 2024. Standards. Innovations. European integration
PHARMEXPERT 2024. Standards. Innovations. European integration
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