2025 Event

RAPS Convergence

Date: October 7th-9th
Location: David L. Lawrence Convention Center, Pittsburgh, PA

Visit us at booth #721
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As the world’s largest annual gathering of regulatory professionals and innovators, RAPS brings together multiple stakeholders to share and discuss regulatory insights and business strategy. Michael Day, Senior Director of Regulatory Strategy and CMC at Cencora, will present best practices on identifying and mitigating risks of an FDA behind recent FDA Complete Response Letter (CRLs). Join us at RAPS to network and explore key industry issues. 
 

Join us for a speaker session

Regulatory agility in action: Avoiding FDA CRLs with the strategic VDC approach

Wednesday, October 8, 2025 
11:55 AM - 12:20 PM EST 

With the FDA’s new transparency initiative, the industry now has direct access to a wave of Complete Response Letters (CRLs)—many of which center around preventable issues in CMC and regulatory alignment. This session will examine key lessons from recent CGT-related CRLs and demonstrate how sponsors can avoid similar pitfalls through proactive regulatory planning, integrated submission strategy, and the application of a Virtual Development Center (VDC) model. The session will highlight real-world examples and offer actionable insights for regulatory leaders preparing INDs, BLAs, and high-risk programs. 
Michael Day headshot

Our speaker

Michael Day, Ph.D.

Michael Day, Ph.D., is Senior Director of Regulatory Strategy and CMC at Cencora. With more than 25 years of experience in pharmaceutical development and regulatory affairs, Mike specializes in U.S. FDA strategy, regulatory due diligence, and CMC lifecycle management for both early- and late-stage assets. He has led global development programs across a wide range of therapeutic areas, including biologics, biosimilars, and complex combination products. In his current role, Mike advises private equity firms, NewCos, and established biopharma companies on regulatory risk assessment, IND/BLA planning, and integrated regulatory-CMC strategies that support global commercialization.

Meet our experts at the booth #721

Ricky Echols headshot
Ricky Echols
Regional Director
Alex Almond headshot
Alex Almond
Market Access Consultant
Michael Day headshot
Michael Day, Ph.D.
Senior Director of Regulatory Strategy and CMC

With team across North America, Europe, and Asia-Pacific region, we blend global reach with local expertise

3,000
Consultants worldwide
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Global markets covered
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Brands represented

Helping breakthroughs break through
 

At Cencora, we’re leading the way to a place where your life-changing therapies can soar to impossible heights. Together, let’s create healthier futures for more patients around the globe.
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Navigate the regulatory approval process with ease

Whether you are developing medicinal products, consumer healthcare products, or veterinary products, our team has the necessary scientific, regulatory, and technical experience to support you. Our regulatory affairs, operations, and chemistry, manufacturing, and controls (CMC) services portfolio supports companies of all sizes across the product life cycle, from product development and initial submission through launch and life cycle management.
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Webinar

Know Your Market: US and EU Regulatory Expectations for Combination Products

The increased prevalence of combination products requires a deeper understanding of what regulators expect in different markets and the kinds of studies required. Manufacturers will need to consider how to manage the different regulatory activities, such as usability testing and bridging studies, that are involved with drug and device development.

Additional resources

Technologies in healthcare

Breaking through early development challenges: BIO panel takeaways

AI Technology

What Project Elsa means for the FDA’s approach to AI

Meet with us at RAPS Convergence

Interested in learning more? We're here to answer questions and support your commercialization needs. Schedule time to meet with our team at the event.

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