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:
Efforts to enhance the system in the Eurasian Economic Union (EAEU) focus on:
About the conference:
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.
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
About the conference:
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.