THE FORUM HAS TAKEN PLACE!
RESOLUTION
FORUM
“CLINICAL AND PRECLINICAL RESEARCH IN WARTIME:
ORGANIZATION AND DEVELOPMENT PROSPECTS”
The Forum "CLINICAL AND PRECLINICAL RESEARCH IN WARTIME: ORGANIZATION AND PROSPECTS FOR DEVELOPMENT", which took place successfully on November 28, 2025, at the Lviv Palace of Arts, Lviv, was organized jointly by the State Expert Center of the Ministry of Health of Ukraine and the State Non-Profit Enterprise "Danylo Halytsky Lviv National Medical University" on the initiative of the Ministry of Health of Ukraine, in cooperation with LLC "UkrKomExpo", with the support of the Lviv Regional Military (State) Administration and the Institution "Lviv Regional Development Agency"; main partners: LLC "Arensia Exploratory Medicine Ukraine", LLC "MSD Ukraine", LLC "AstraZeneca Ukraine", JSC "Lekhim", JSC "Farmak"; special partners: the Ukrainian Association for Clinical Research (UACR), the European Business Association (EBA), AIPM Ukraine, APRaD, the Association "Medical Device Market Operators" (AMOMD); and with the information support of the publications "The Pharma Media" and the Pharmaceutical Journal.
The Forum became an open professional platform for strategic dialogue among key participants in the clinical research sector in Ukraine, strengthening cross-sector interaction and international cooperation, and developing educational and research initiatives.
The program of the Forum consisted of plenary sessions with international speakers and panel discussions devoted to the Ukrainian and global context of clinical research, global trends, the future of research, organizational processes, innovation, ethics and trust, and patient-centricity, as well as a space for building partnerships and exchanging experience.
In his welcoming address, Minister of Health of Ukraine Viktor Liashko stressed that, despite the war, the trust of international partners in Ukraine remains high and the field of clinical research is demonstrating steady development. As of November 2025, 294 clinical studies are being conducted or are preparing to start in Ukraine, and the number of new applications from international sponsors has grown by almost 18%. The MoH continues to implement European rules, is building a network of clinical sites, and is investing in modern equipment and laboratories, which ensures patients' access to innovative treatment and Ukraine's integration into the global scientific community. The Minister also reported that in 2027 the provisions of the Law of Ukraine "On Medicinal Products", adopted in 2022, which establish modern requirements for the development and clinical trials of medicinal products, are expected to enter into force. It was separately emphasized that clinical studies must be conducted at clinical medical sites, with university hospitals playing a key role as centers of scientific and highly qualified human resources.
Mykhailo BABENKO, Doctor of Pharmaceutical Sciences, Director of the State Expert Center of the Ministry of Health of Ukraine, welcoming the participants of the Forum, noted, among other things, that for a state that is simultaneously facing large-scale challenges and demonstrating resilience and the capacity for modernization, the development of the clinical research system is of not only professional but also strategic importance. Clinical trials, as a key stage in the creation of any medicinal product, have become an area in which the industry has demonstrated competitiveness in Ukraine even in difficult times. The support of the EU and international partnerships show that the Ukrainian regulatory system is moving in the right direction, and this movement has already been endorsed by external colleagues. For three decades, the mission of the Center has been to provide Ukrainian patients with safe, effective, and high-quality medicinal products and access to affordable treatment based on the principles of evidence-based medicine.
In his welcoming address, the Rector of the State Non-Profit Enterprise LNMU, Doctor of Medical Sciences, Professor Orest Chemerys, presented the paradigm of the University's transformation into a national hub of medical education based on the combination of science, education, and clinical practice. In this context, the University Hospital emerges not merely as another medical institution but as a key element of the new development model: a space where the philosophy of providing medical care is changing, the role of medical professionals is expanding, and a modern practical environment for students is being formed. The opening of the Center for the Coordination of Clinical and Preclinical Research at the University Hospital is yet another brick in building a hospital with state-of-the-art technologies, equipment, innovative methods of providing medical care, and highly qualified human resources, and the development of preclinical and clinical research is one of the University's strategic directions.
The Forum "CLINICAL AND PRECLINICAL RESEARCH IN WARTIME: ORGANIZATION AND PROSPECTS FOR DEVELOPMENT" was attended by 315 participants (263 offline and 52 online), and about 350 more participants watched the live broadcast of the event on YouTube. The Forum brought together representatives of public authorities, sponsors, international partners, scientific institutions, the pharmaceutical industry, contract research organizations, professional associations, doctors, researchers, and young scientists.
Taking into account the key points made, today's challenges, and the proposals put forward, the Forum emphasizes the shared readiness of the state, the scientific and medical community, and international partners to develop in Ukraine an innovative, competitive, and resilient clinical research system that provides patients with access to modern treatment and strengthens Ukraine's position on the global research map. Ukraine is moving along the path of European integration, adapting national practices to EU standards, preserving effective mechanisms, and meeting modern global requirements.
The Forum resolves:
Recognizing the strategic value of the clinical research sector
Clinical research is recognized as a strategic area of development of Ukraine's health care system, ensuring:
- patient access to innovative treatment methods,
- development of clinical and scientific expertise,
- attracting investment in medical infrastructure and enhancing the country's competitiveness,
- strengthening the scientific potential of the state,
- Ukraine's integration into the European and global research area,
- freedom of entrepreneurial activity in the conduct of clinical research, provided that the requirements of Ukrainian legislation, the rules for conducting clinical research, and the standards of Good Clinical Practice (GCP) are strictly observed.
- Emphasizes that Ukraine's competitive advantage lies in the wide availability and diversity of its network of research centers – academic, state, municipal, and private – with broad geographic coverage, experience, high quality of performance, and access to diverse categories of patients.
Shaping a coherent state policy for the development of clinical research
The Forum recommends developing and approving a National Strategy for the Development of Clinical Research, focused on:
- harmonization with European Union law, Regulation (EU) No. 536/2014, and the principles and standards of GCP and GLP;
- furth
er implementation of the principles of the European Charter for Researchers (European Charter for Researchers and Code of Conduct for the Recruitment of Researchers (2005), which is an internationally recognized standard aimed at creating an open, transparent, and non-discriminatory environment for researchers and research institutions;
- preparing Ukraine for integration into the Clinical Trials Information System (CTIS) as a tool for transparency, predictability, and international recognition of clinical research results. Integration into CTIS should be carried out in stages, without creating excessive administrative barriers for applicants;
- ensuring long-term stability, predictability, and uniformity of regulatory rules and procedures for all participants in the clinical research market;
- development of clinical research centers at university clinics as a key component of an established clinical research sector, taking into account support for and complementing the existing market, as its equal participant;
- recognition that the key condition for involving research centers in international studies is their compliance with European criteria;
- development of various types of sites — academic, state, municipal, and private;
- strengthening of human resource capacity, digital infrastructure, and quality management standards.
In line with the strategy, continue the development and harmonization of Ukraine's legislation in the field of preclinical and clinical research with EU requirements, in particular regarding GLP and GCP
- Ensure full preparation for the 01.01.2027 entry into force and implementation of the provisions of the Law of Ukraine “On Medicinal Products” of 2022
- Introduce a new procedure for conducting clinical research harmonized with Regulation (EU) No. 536/2014, in compliance with its key provisions.
- Create conditions for international recognition of research results and for increasing Ukraine's investment attractiveness, in particular through integration into CTIS.
- Ensure uniform rules for all types of clinical research (interventional, low-intervention, international multicenter, bioequivalence) and for all applicants/sponsors (domestic and international).
- Move the submission of documents and interaction with state authorities to an electronic format to minimize bureaucracy and increase efficiency; develop electronic communication channels to ensure the continuity of clinical research.
- Harmonize the work of ethics committees with European norms, especially for the protection of vulnerable groups (children, pregnant women, persons with limited legal capacity).
- Develop systematic scientific and expert oversight by the state control authority (SCA) across the full life cycle of clinical research: consultations, protocol approval, safety monitoring, and coordination with international bodies.
- Encourage transparency and openness of information about research by publishing data on the websites of health care institutions.
- Identify the key obstacles and development priorities of research centers: safety risks, planning and patient availability, logistics of investigational medicinal products, and workload on teams, and promote the introduction of effective models for overcoming them.
- Ensure the predictability of clinical research in Ukraine, of start-up timelines, and of patient recruitment, so that international sponsors can plan studies effectively and with confidence.
- Maintain the high quality of centers and research teams, guaranteeing the reliability and reproducibility of results.
- Strengthen cybersecurity and establish backup data storage systems, including cloud solutions.
- Develop standardized site profiles (“site feasibility package”) for international sponsors.
- Support the harmonization of standards and the trust of the international community based on ICH principles: every stage from the molecule to the clinical study guarantees safety and efficacy; science, ethics, and quality remain the key principles of regulatory policy; implementation of ICH as a strategic vector for the development of Ukraine's regulatory system.
University hospitals in the clinical research system
- Support the MoH experimental project, the transformational model of LNMU, which ensures synergy between science, education, and clinical practice and promotes the formation of a high-tech university hospital. University hospitals are recognized as an important component of the clinical research ecosystem. Their development should take place within the framework of a nationwide strategy, without violating the principles of competition and equal access for market participants.
- The Forum supports the creation of Clinical Research Offices at university hospitals, with coordinators, quality managers, IT support, and standardized procedures.
- Ensure the operation of independent ethics committees at university hospitals, and provide for unified procedures and digital submission of materials.
- Include the “clinical trials” area in the educational programs of medical universities: ICH, research methodology, practical skills.
Develop Ukraine's integration into the international quality control system for preclinical and clinical research
- The Forum emphasized that preclinical studies are an integral part of the medicinal product development process for establishing a safe starting dose and a safe dose range for human use, determining the parameters of clinical monitoring of potential adverse reactions, and conducting pharmacological, pharmacokinetic, and toxicological studies, in which every experiment has perfectly clear objectives and addresses specific tasks.
- Preclinical studies on the toxicity and safety pharmacology of medicinal products are conducted in compliance with international GLP (Good Laboratory Practice) standards, including the scientific and ethical principles, rules, and practices of conducting studies adopted worldwide (OECD, ICH, FDA documents, EU directives, etc.), the main provisions of which have been implemented in the legislation of Ukraine.
- The Forum reaffirms the key role of clinical audit/inspection as a tool for ensuring quality, data reliability, and the protection of the rights of research participants in accordance with GCP principles.
- Declare that the clinical audits of the State Expert Center of the Ministry of Health of Ukraine provide not only oversight but also partnership, support, and development of research centers, helping to establish high standards and reliability of research.
- Strengthen the quality control system for clinical research by developing clinical audit/inspection in accordance with the international GCP standard.
- Continue the process of harmonizing Ukraine's regulatory legal acts on the control of preclinical studies and clinical trials with European requirements and regulatory practices;
- Strengthen cooperation with the regulatory authorities of EU countries on GLP and GCP inspections;
- Promote Ukraine's integration into the international control system for preclinical studies and clinical trials;
- Facilitate the issuance of guidelines, methodological recommendations, and regulatory documents related to the organization, conduct, and control of preclinical studies and clinical trials.
- Define proof of bioequivalence as a key tool for ensuring the efficacy, safety, and quality of generic medicinal products, allowing them to be registered without a full clinical trial program (phases I–III). Promote the adoption of international standards for conducting bioequivalence studies in Ukraine.
- Ensure the synchronization of scientific and clinical data with the instructions for medical use, minimizing the "gap" between the results of clinical studies and the information set out in the document. Promote the continuous updating of instructions for medical use so that the information is up to date and meets international standards, ensuring the maximum level of safety for patients.
Recognize the development of advanced therapies (Advanced Therapies) as one of the key strategic directions for modernizing Ukraine's health care system
- Support the introduction of advanced therapies as a tool for expanding patient access to innovative treatment, in line with global trends and state priorities in oncology, hematology, rare diseases, and immune pathologies.
- The Forum recognizes the development of advanced therapy medicinal products (ATMP) (cell, gene, and tissue) as a strategic direction for modernizing Ukraine's health care system.
- Harmonization of regulatory requirements for ATMP with EU requirements, development of GMP infrastructure and point-of-care models, and Ukraine's involvement in international scientific consortia are recommended.
- Declare that Ukraine has all the prerequisites to become a regional leader in advanced therapies and in conducting clinical research on advanced therapy medicinal products.
- Support cross-sector cooperation between the state, clinics, scientific centers, and international partners to create in Ukraine:
- international-level centers for advanced therapies,
- educational programs in cell and gene therapy.
Support the development of professional incentives for work in clinical research
Recognize the concept of medical centers of excellence, “Site of Excellence,” as a horizon for the development of clinical medicine that forms modern centers of competence and excellence integrated into national and international medical networks.
Recognize clinical research as a key driver of medicine, ensuring:
- enrichment of scientific knowledge;
- improvement of clinical practice through the introduction of new treatment standards;
- improving the quality of medical education;
- forming a generation of specialists capable of working as a team on the principles of evidence-based medicine and a personalized approach to the patient.
Development of educational programs and human resource potential of the sector, international cooperation, and scientific and educational synergy in clinical research
- Introduce a national program for developing research competencies, including training of coordinators, investigators, quality managers, and heads of health care institutions, ensuring conditions for a human resource reserve and for the continuous professional development of medical personnel in Ukraine.
- Regard the State Expert Center of the Ministry of Health of Ukraine as a center for building human resources at the European level through participation in the development and implementation of new professional standards, training programs, and the development of key competencies; as an active participant in developing the expert professional community in the field of health care, which introduces innovative practices in Ukraine, guided by international recommendations and current trends and adapting the best global practices to Ukraine's needs, in particular by holding regular training seminars for researchers, sponsors, CROs, ethics committees, and regulators
- Recognize international cooperation and scientific and educational synergy as key factors in the development of Ukrainian medical science, clinical trials, and integration into the European and global research area.
- Facilitate access to international resources and expertise, including unique technologies, laboratories, and specialists, to improve the quality, reliability, and scientific value of clinical research.
Ethics, human rights protection, transparency, and patient engagement
- Ethical standards and informed consent are the foundation of trust in the clinical research system. Local ethics committees and patient organizations protect the rights of participants, promote transparency of processes, and foster a culture of voluntary participation in research and in compassionate use programs for medicinal products.
- Enhance the role of local ethics committees in monitoring compliance with ethical norms and the rights of participants, including vulnerable groups (children, pregnant women, persons with limited legal capacity).
- Develop cooperation with patient organizations to foster a culture of transparent participation in research and in compassionate use programs for medicinal products.
- Raise patients' awareness of opportunities to participate in clinical studies and ensure the participation of patient representatives in shaping policies on clinical trials. Develop a transparent reporting and publication system for information on clinical studies that is accessible to patients and increases the trust of society and international partners.
Real-world evidence: harnessing the potential of RWE
- Emphasize that modern patient access to innovative treatment, in the world and in Ukraine, is increasingly determined by evidence-based data, where the market access ecosystem covers a comprehensive process that combines clinical studies, registration, health technology assessment (HTA), including analysis of economic feasibility, reimbursement and pricing, and analysis of real-world data (RWE).
- Emphasize that the development of the HTA system should be regarded as an important tool for providing patients with access to modern and effective treatment based on reliable evidence.
- Create conditions for promoting and conducting phase IV studies and pragmatic studies, including those involving the analysis of real-world clinical practice data, which is appropriate for use, among other things, during HTA. Ensure routine registration of non-interventional RWE studies and full disclosure of methods, processes, and results. Support the creation of real-world clinical practice registries.
Confirm the commitment to proactive pharmacovigilance
- The Forum notes that pharmacovigilance in clinical research is moving toward a proactive, patient-centered model: safety is built in from the early phases, risks are anticipated and controlled, and data are used responsibly.
- The role of the investigator is being transformed: from a data recorder to a moderator of safety information, a communicator with the patient, and a participant in real-time signal management.
- The patient becomes an active partner: helps shape the safety profile, endpoints, inclusion/exclusion criteria, and key risks; data are collected through digital tools, remote monitoring, and RWD/RWE.
The Ukrainian scientific community, researchers, local representatives of pharmaceutical companies and contract research organizations, the Ukrainian Association for Clinical Research, the European Business Association, research institutions, Ukrainian and international public figures, the Ministry of Health of Ukraine, the State Expert Center of the Ministry of Health of Ukraine, and the State Non-Profit Enterprise "Danylo Halytsky Lviv National Medical University" call on international sponsors of clinical studies to regard Ukraine as a country with great potential for conducting clinical studies, including in wartime.
The Resolution based on the results of the Forum “Clinical and Preclinical Research in Wartime: Organization and Development Prospects” was adopted as a basis, finalized by the Organizing Committee as instructed by the Forum, and approved as a whole.
We separately express our sincere gratitude to all the highly professional researchers of Ukraine, active representatives of international sponsors in Ukraine, clinical research specialists, logistics teams, CRO representatives, associations, public unions, and regulatory authorities!
Thanks to your resilience and unwavering belief in the value of human life, clinical research in Ukraine is not merely continuing but developing, opening the way to new opportunities and strengthening the future of Ukrainian science. Your work makes the advancement of science possible, gives patients access to innovative treatment methods, and strengthens Ukraine's position in the global research community in these difficult times for our Country during the military aggression of the Russian Federation.
Sincerely
Organizing Committee
OF THE FORUM “CLINICAL AND PRECLINICAL RESEARCH IN WARTIME: ORGANIZATION AND DEVELOPMENT PROSPECTS”
FORUM MATERIALS
