Workshop A: Harmonising Process Development & Regulatory Standards to Improve Comparability Changes & Accelerate Routes to Market
Time: 8:30 am
day: Pre-Conference Day
Details:
Blurred regulatory standards are hindering advancement in mRNA process development, analytical development and manufacturing. With fast-tracked approval for mRNA vaccines previously granted for COVID-19, uncertainty now surrounds the application of mRNA for other disease indications. This workshop will unite key regulatory leaders to shed light onto acceptable regulatory standards and better understand how to tackle them.
Topics include:
- What are the acceptable quality standards for drug substance and product release?
- How much we can leverage from previously approved platform technologies to facilitate future regulatory approvals?
- How can we better comply with regulators to smoothen the CMC process for mRNA platform technologies?