Panel Discussion: Sharing Regulatory Navigation Strategies Across Global Agencies to Reduce Uncertainty & Accelerate Clinical Progression

• Benchmarking regulatory pathways used across FDA, EMA & national authorities to clarify expectations and reduce trial approval uncertainty
• Comparing real-world regulatory interactions including key questions, feedback loops & submission strategies to strengthen future applications
• Identifying common pitfalls in CMC, trial design & product characterisation to proactively mitigate delays in regulatory approval processes

Speakers:

Paul Carlson

Principal Investigator

US Food & Drug Administration (FDA)

Bharat Dixit

Chief Technology Officer

Adiso Therapeutics

Kingyin Lee

Head of Clinical Trials

MHRA