Vaccines, Vaccination and Immunization

Regulatory Affairs and Vaccine Policy

This session will examine regulatory science, vaccine authorization, policy development, and post-approval oversight. Discussions will cover regulatory pathways, quality requirements, clinical evidence, benefit-risk assessment, licensing, manufacturing standards, and post-marketing monitoring. Experts will discuss how regulatory authorities evaluate vaccine quality, safety, and effectiveness before and after authorization. The session may also address international regulatory collaboration, harmonization, emergency-use pathways, and policy decisions surrounding vaccine introduction. Researchers, pharmaceutical companies, regulatory professionals, clinicians, and policymakers can share experiences and perspectives on navigating complex vaccine-development requirements. The session will provide an opportunity to understand the evolving regulatory environment and explore approaches that support timely access to safe, effective, high-quality vaccines while maintaining appropriate scientific and regulatory standards.