Effective regulatory pathways and approval processes balance the urgency of public health needs with rigorous safety and efficacy standards. National and international agencies evaluate data across clinical phases to authorize vaccines for emergency or general use. Conditional approvals, rolling submissions, and priority reviews have become more common, particularly in response to pandemics. Clear guidance on dossier requirements, manufacturing practices, and pharmacovigilance expectations helps streamline developer timelines. Regulatory pathways and approval processes must remain adaptable to new technologies like personalized vaccines and nanocarrier systems. Global harmonization efforts, such as reliance models and mutual recognition agreements, are enabling faster cross-border access. Transparent, science-based regulation fosters trust, accelerates innovation, and ensures public confidence in immunization programs.
Title : The importance of post-marketing surveillance and real-world data for a product to be successful
Regina Au, BioMarketing Insight, United States
Title : Nanoscopic SubATVax™ adjuvanted vaccines against influenza A types H3N2, H1N1 and influenza type B for subcutaneous administration
David Craig Wright, D4 Labs, LLC, United States
Title : Prophylactic and molecular approaches for mitigating human influenza A viruses: i. Evaluating influenza vaccine effectiveness in the older population ii. Down-regulation of influenza virus genes with novel sirna-chimeric-ribozyme constructs
Madhu Khanna, University of Delhi, India
Title : A promising novel approach to DNA vaccines
Khursheed Nadeem Anwer, IMUNON, United States
Title : The role of immunity in the pathogenesis of SARS-COV-2 and in the protection generated by COVID-19 in different age groups
Ahmed Abdulazeez, BHRUT Trust, United Kingdom
Title : Establishing a platform method for physical appearance assessment of new parenteral pharmaceuticals
Ying Wan, Merck & Co., United States
Title : Advances in vaccines: Revolutionizing disease prevention
Delia Teresa Sponza, Dokuz Eylul University, Turkey
Title : Overcoming biophysical characterization challenges of small antigens in dilute vaccine formulations
Eric Kemp, Merck & Co., United States
Title : Commensal bacteria drive B-cell lymphomagenesis in the setting of innate immunodeficiency
Ping Xie, Rutgers University, United States
Title : A combined LC-MS and immunoassay approach to characterize preservative-induced destabilization of human papillomavirus virus-like particles adsorbed to an aluminum-salt adjuvant
Ria T Caringal, University of Kansas, United States