Quality, Safety & Efficacy: Building a Phase-Appropriate Foundation for Regulatory Success in LNP Development

Time: 9:00 am
day: Conference Agenda

Details:

• Understanding how quality, safety, and efficacy data requirements evolve from early clinical trials to marketing authorization, and why foundational thinking should start early for safety and approval
• Reframing regulatory frameworks as protective tools for both patients and developers, mitigating legal risk while guiding better science
• Identifying and addressing data gaps early on to ensure a comprehensive understanding of product behavior and de-risk development decisions to ensure smoother approval

Speakers:

Ka-Wai Wan Dr Ka-Wai Wan is a pharmacist by training and graduated from The School of Pharmacy (University of London). She was trained as a hospital pharmacist Read more