Accelerating development timelines requires more than ambition—it demands strategy. In this on-demand webinar, MMS experts share actionable insights into how sponsors can effectively navigate expedited regulatory pathways to bring therapies to patients faster, particularly in areas of high unmet medical need.
From FDA Fast Track and Breakthrough Therapy Designation to EMA PRIME and Conditional Marketing Authorisation, this session offers a comprehensive look at global acceleration programs and how to apply them strategically throughout your development journey.
Led by:
Ben Kaspar, VP, Global Regulatory Strategy
Sam Miller, VP, Statistical Consulting Services
Ben Dudley, Chief Commercial Officer
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Understand how FDA and EMA expedited programs align with your clinical goals
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Learn how to optimize study design, endpoints, and data strategies for faster approvals
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Identify best practices to avoid late-stage regulatory challenges
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Key differences and overlaps among global acceleration pathways
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How to leverage surrogate and intermediate endpoints to demonstrate efficacy
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What steps to take when an official designation isn’t granted
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How the FDA’s upcoming National Priority Review Voucher program may change development planning
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Regulatory Affairs and Strategy Professionals
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Clinical Development and Operations Teams
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Biostatisticians, Data Scientists, and Modelling Experts
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Emerging Biotech and Pharmaceutical Leaders
Who is this webinar for?
This webinar and panel discussion is designed for regulatory affairs professionals, clinical development leaders, medical and scientific strategists, and anyone involved in or exploring the evolving landscape of psychedelic drug development.
Will there be a recording available?
Yes, a recording will be shared with all registered attendees after the live session.
Where can I get more information on the content presented?
To connect with the presenters or learn more about the topics discussed, please email info@mmsholdings.com and our team will direct your inquiry to the appropriate expert.
Access this on-demand webinar now to gain expert perspectives, practical examples, and strategic takeaways designed to help sponsors accelerate development while maintaining regulatory confidence.
Register Now
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