Nitisha Pyndiah
Seminars
Thursday 2nd January 2025
Panel Discussion : Uniting Regulatory Experts from Industry & Agencies to Navigate the Complex Landscape for mRNA-Based Medicines
9:30 am
- How do the FDA, EMA and MHRA define a “platform” and what are the paths available to mRNA drug developers to utilize “platforms” as a way to expedite approvals
- Is it the right time to start developing mRNA specific regulatory guidance and should there be separate guidelines for each therapeutic area and/or application?
- What tools and expectations apply to companies exploring novel mRNA applications without an established platform or previous experience with large-scale batch production?
Panel Moderator: Emily English
Virtual Speaker: Marco Cavaleri
Tuesday 31st December 2024
Planning for Success: Creating a Regulatory Strategy for the Successful Development of a Novel mRNA Platform
12:00 pm
