Navigating the Regulatory Frameworks To Spearhead the Drive for Increased LNP Approvals
Time: 11:00 am
day: Pre-Conference Workshop Day
Details:
The LNP world will long celebrate the approval of Moderna’s COVID-19 vaccine – but how did they achieve such a feat?
Join representatives from Moderna to debunk the regulatory myths and share their pathway to success, in addition to fundamental lessons learnt which have been taken forward!
- Sharing insights into regulatory interactions experienced when preparing submission of LNP drug products
- Revealing the quantity and quality of data packages required to satisfy the regulatory bodies
- Developing an analytical structure from early-stage development with regulatory guidelines at the forefront of design
