A practical, discussion-led session where participants work through real regulatory scenarios, aligning analytical, CMC and development strategies with phase-appropriate expectations to accelerate clinical progression.

• Clarify what “phase-appropriate” development really means in practice
• Identify where teams over-engineer and over-characterise LNP systems
• Understand how to prioritise critical data vs nice-to-have data
• Align analytical, CMC and clinical strategies with regulatory expectations
• Reduce delays caused by misaligned development strategies