This materials was prepared as part of the work on the EURIZON project, which is funded by the European Union under grant agreement No.871072
Detailed information on each of the 7 conducted online workshops
Workshop: SPECIFICS OF DEVELOPMENT AND TESTING OF BIOLOGICAL ORIGIN PRODUCTS (speaker – Tetiana Lutsenko), 17/10/2024
During the workshop, the following information was considered: an overview of key concepts, types of biological products and the role of biotechnology in their production, stages of development of products of biological origin, methods of quality control of biological products. In addition to production aspects, the peculiarities of planning and carrying out preclinical and clinical research of bioproducts were also considered. Regulatory requirements for biologically derived products were also addressed, including an overview of regulatory requirements, approval procedures and key regulators.
Workshop: BIOSAFETY OF BIOMEDICAL PRODUCT TECHNOLOGIES (speaker – Olena Holembiovska), 21/10/2024
During the workshop, the following information was considered: a comprehensive exploration of the critical measures and practices necessary to ensure the safety of biological products throughout their lifecycle. From development and manufacturing to clinical use and eventual disposal, biosafety is paramount in protecting researchers, patients, and the environment from potential risks associated with biological materials. Participants were introduced to the fundamental principles of biosafety, emphasizing the importance of implementing robust safety measures at every stage of a product’s lifecycle. Historical case studies, including the Sverdlovsk anthrax leak in 1979, illustrated the catastrophic consequences of biosafety failures and highlighted the need for stringent protocols. The recent SARS-CoV-2 Delta leak in November 2021 underscored the ongoing challenges in managing biological risks and the importance of rapid response mechanisms.
The workshop delved into methodologies for assessing risks associated with biomedical products, focusing on identifying and mitigating potential hazards. Participants explored major biosafety risks present in the field, understanding the implications these risks have for public health and safety. Discussions covered essential regulatory frameworks governing the development and manufacturing of biomedical products, ensuring that safety standards are met. Attendees learned about testing protocols necessary for ensuring the safety and efficacy of biomedical products before they reach the market. The importance of post-market surveillance was emphasized, highlighting the need to monitor biomedical products after their release to identify any unforeseen risks and ensure ongoing safety.
Finally, the session addressed strategies for emergency preparedness in the event of biosafety breaches, equipping participants with the knowledge to respond effectively to potential crises.
Workshop: BIOSAFETY AND BIOSECURITY IN BIOLOGICAL RESEARCН (speaker – Oleksandr Besarab), 23/10/2024
A workshop on biosafety and biosecurity in biological research was recently conducted, covering essential aspects of managing biological hazards in laboratory settings. The workshop provided an overview of biosafety and biosecurity principles and discussed factors that contribute to both potential and confirmed impacts of biological agents.
Participants reviewed all stages of risk assessment to ensure biosafety, including identifying hazards, evaluating risks, implementing control measures, and monitoring the effectiveness of these measures. Key aspects of good microbiological practices and protocols were emphasized, as well as the critical need for personnel training to maintain high standards of safety and minimize risks associated with biological research.
The workshop also covered requirements for designing biological laboratories, handling and storing biological samples, and managing biological waste. An essential component was also the use of personal protective equipment (PPE) and occupational safety measures to protect researchers and laboratory staff.
The practical part of the workshop focused on risk assessment and involved two tasks. In the first task, participants selected a biological experiment, identified potential risks, and examined the associated consequences. The second task involved applying expert systems theory to assess risk probabilities and outcomes by gathering expert evaluations. This hands-on approach allowed participants to put theoretical knowledge into practice and enhanced their understanding of risk management in biosafety and biosecurity.
Workshop: BIOCOMPATIBILITY OF MEDICAL DEVICES AND BIOSAFETY (speaker – Vladyslav Kasianenko), 25/10/2024
The workshop on “Biocompatibility of Medical Devices and Biosafety” focused on critical aspects of ensuring the safety and efficacy of medical products. Participants explored the significance of biosafety symbols associated with medical devices and the application of relevant standards, including ISO 10993, which outlines requirements for the biological evaluation of medical devices.
The workshop aimed to clarify the objectives of biological evaluation, emphasizing its role in identifying potential risks associated with medical devices. Attendees engaged in an in-depth discussion of two specific case studies that illustrated real-world challenges and solutions in the realm of biocompatibility and biosafety.
Throughout the session, the speaker employed various techniques to maintain the audience’s attention, ensuring active participation and engagement. By integrating interactive elements and encouraging questions, the speaker created an environment conducive to learning. This approach not only helped clarify complex concepts but also reinforced the importance of biocompatibility and biosafety in the development and use of medical devices. Overall, the workshop provided valuable insights into the regulatory landscape and practical considerations essential for ensuring the safety of medical products.
Workshop: MEDICAL BIOTECHNOLOGY. BIOSAFETY AND BIOSECURITY (speaker – Larysa Kalashnikova), 29/10/2024
The workshop on “Biosafety of Medical Biotechnologies” provided an in-depth exploration of the safety considerations associated with the rapidly evolving field of medical biotechnology. With 45 participants, the session lasted 2.5 hours and fostered a collaborative learning environment.
Key objectives of the workshop included summarizing the biohazards associated with genetic engineering and cellular engineering methods. Participants engaged in discussions about various biotechnological advancements, including biochips, stem cells, genetically modified organisms (GMOs), and tissue engineering.
The workshop featured interactive discussions, where participants were divided into four groups based on specific questions. Each group conducted discussions on their chosen topics and presented their findings, enriching the overall discourse with diverse perspectives.
Key discussion points included:
- Biochips in Medicine: Participants examined the transformative potential of biochips while addressing associated risks, such as data security and ethical implications.
- Stem Cells: The group discussed the benefits and risks of stem cell applications in treating diseases, considering ethical and regulatory frameworks.
- Genetically Modified Organisms (GMOs): A balanced discussion focused on the advantages of GMOs in agriculture versus potential health and environmental risks.
- Tissue Engineering: Participants explored the complexities and challenges of tissue engineering, including safety issues and integration with human tissues.
In addition to group discussions, individual presentations on tissue engineering provided further insights into specific aspects of the topic. An experienced instructor-researcher also contributed by sharing expertise on safety issues in biomedical laboratories, enhancing participants’ understanding of best practices.
Workshop: PREVENTION OF BIOLOGICAL THREATS IN WARTIME (speaker – Igor Khudetskyy), 30/10/2024
Speaker Igor Khudetskyy, provided participants with critical insights into the structure and analysis of biological threats in the context of war. The session lasted 96 minutes and included both informative and interactive elements.
Participants were introduced to the historical context of biological threats during conflicts, exploring various case studies that highlighted how traditional infections have been weaponized in hybrid warfare scenarios. The discussion emphasized the complexities of biological threats, including binary and multi-component biological weapons, as well as the emergence of “war infections” that can exacerbate health crises during wartime.
A significant portion of the workshop was dedicated to an interactive analysis of modern biological threats and biosafety measures. In a hackathon format, attendees were tasked with devising epidemic prevention solutions for pandemic infections, such as COVID-19, within the unique challenges presented by wartime conditions. This hands-on approach fostered collaboration and innovative thinking among participants.
The effectiveness of the proposed epidemic measures was then analyzed, providing a platform for participants to assess the viability and impact of their solutions. This interactive component not only encouraged engagement but also highlighted the importance of preparedness in the face of biological threats during conflicts.
Workshop: CONCEPT OF SPECIALISTS TRAINING IN BIOSAFETY AND BIOSECURITY (speaker – Valentyna Motronenko), 31/10/2024
The workshop focused on modern approaches and methods for preparing professionals in the fields of biosafety and biosecurity, addressing current challenges. Spanning two hours, the workshop aimed to cover essential aspects of education in this area, taking into account participants’ initial qualifications, fields of activity, advancements in science and technology, and other relevant factors. Key topics included:
1. Current Level of Training: Participants assessed the existing competencies of specialists in biosafety and biosecurity.
2. Curriculum Development: Approaches to designing effective training programs were discussed, ensuring alignment with industry needs.
3. Integration of Modern Technologies: The use of contemporary information technologies in educational settings was emphasized, including the implementation of virtual laboratories.
4. Quality Assessment: Participants explored methods for evaluating the effectiveness of training programs based on established learning outcomes.
Throughout the workshop, participants learned to develop training programs for conducting workshops on biosafety and biosecurity, with a specific focus on online formats. They utilized virtual laboratories, specifically the LabXchange platform from Harvard University, to create and integrate practical laboratory exercises into their training modules. This platform offers a cost-free and accessible way to simulate laboratory conditions, enabling users to conduct experiments and analyze results.
Interactive tools were employed to enhance engagement, including surveys using Google Forms to assess participants’ qualifications and knowledge in the context of training specialists in biosafety and biosecurity. The integration of virtual laboratories allowed participants to refine practical skills and gain hands-on experience.
The participants demonstrated a high capacity to process information and master new material, as evidenced by their performance on practical assignments. The positive outcomes highlighted the effectiveness of the chosen methods, the theoretical content provided, and the balance between theoretical and practical components of the workshop. Overall, the workshop successfully equipped attendees with valuable skills and knowledge essential for advancing their expertise in biosafety and biosecurity training.