International Conference "Bioethics and Global Social Transformations": Trends in Digital Transformation in Drug Regulation and Development
2025-06-30 12:45
Elena Popova, Senior Director of Regulatory Affairs & Healthcare at AIPM, presented a comprehensive view of global trends in digital transformation within regulation and drug development at the II All-Russian Conference with International Participation titled "Bioethics and Global Social Transformations" in Yaroslavl, held on June 27 under the auspices of UNESCO.
Key trends include:
A surge in candidate molecules entering clinical development, driven by digital models
The active adoption of AI tools by both industry and regulators across all stages of the drug lifecycle
Reducing reliance on in vivo testing
Establishing anonymized medical databases accessible to drug developers
The increasing development of combined products that integrate drugs, medical devices, and software
New models for clinical trials and data management
Efforts to enhance the system in the Eurasian Economic Union (EAEU) focus on:
Shifting the regulatory paradigm at the EEC level to create modern documents and adapt them automatically where possible, following models like those in China
Actively employing reliance and risk-based approaches
Establishing multidisciplinary competence centers within the EAEU
Revising training methods for industry, regulators, and experts, emphasizing new skills at the intersection of biotechnology, genetics, AI, and specialized medical knowledge
Extensive use of AI in regulatory bodies and industry operations
Striking a balance between protecting personal data and providing anonymized data for innovation and research
Ensuring transparency in decision-making to boost trust among the population and regulatory bodies in potential export countries
The conference, held on June 27-28, brought together approximately 1,000 scientists, professors, students, public organization representatives, and media. Participants from the EAEU and BRICS countries discussed ethical challenges posed by AI in healthcare, education, and research. The forum also covered neurotechnologies, drug and medical device regulation, pharmacology, genetics, biology, bioeconomics, innovative medicine development, and social bioethical issues.