Iulia Oita

Company: Ziphius Vaccines NV

Job title: Chemistry, Manufacturing & Controls Manage

Seminars:

Understanding Standards & Regulatory Requirements for Analytical Development of mRNA Vaccines to Ensure Safety & Efficacy 9:00 am

Reviewing standards and regulatory requirements is critical for mRNA vaccines. To do so, we can look at the entire process from research and development to clinical trials and post-market surveillance. This includes evaluating the manufacturing process, assessing the safety and efficacy of the vaccine, and monitoring for any adverse events. Additionally, it’s important to consider…Read more

day: Pre-Conference Workshop Day

Exploring the Analytical Toolbox Supporting Early-Stage Development of Process & Product Development for saRNA Vaccines 2:30 pm

Analytical tools needed to support process development of saRNA manufacturing Looking into analytical tools needed for formulation development of saRNA LNPsRead more

day: Conference Day Two

Panel Discussion: Reviewing Standards & Regulatory Requirements of the Analytical Field of mRNA-based Therapeutics to Accelerate Approvals 12:00 pm

Delving into how to give evidence of a state of control and maintain regulatory compliance for your mRNA analytical techniques Revealing how to integrate the new novel mRNA analytical technologies to align with GMP guidelines Understanding how to standardise your mRNA analytical techniques to align to CQA’s & CPI’s to allow efficient and rapid approvalRead more

day: Conference Day Two