Vaccines Policy and Regulatory Affairs
Vaccines Policy and Regulatory Affairs
Vaccination policies, formulated over the past two centuries since the advent of vaccinations, aim to safeguard public health by preventing diseases and strengthening immune responses in targeted populations. The initial focus of programs like the Expanded Program on Immunization (EPI), established four decades ago, was primarily on administering conventional vaccines to infants. However, the landscape of vaccination has profoundly evolved since then.
In the realm of regulatory affairs, entities such as the European Medicines Agency (EMA), World Health Organization (WHO), and United States Food and Drug Administration (USFDA) have already instituted comprehensive regulatory frameworks to guide vaccine development. Yet, in various regions globally, the establishment of national-level regulatory structures for vaccines remains in its early stages. Negotiating the intricate web of global vaccine regulations necessitates specialized practical experience and a deep understanding of regulatory intricacies