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Xtalks, Online
2025-11-06
When it comes to early phase research, the way a product is formulated and manufactured can significantly impact not just the quality of the data but the success of the study itself. Many researchers and sponsors default to USP-based compounding due to speed or familiarity, without realizing the risks this introduces in terms of consistency, regulatory compliance and analytical depth. As regulatory expectations increase and the push for translational fidelity grows, the choice between USP compounding and GMP manufacturing becomes more than just a technical decision; it’s a strategic one.
In this webinar, the featured speakers will explore the critical differences between these two approaches and why starting with GMP, even in early phase development, can save both time and resources downstream.
Register for this webinar to learn about the advantages of GMP over USP in early phase development.
Keywords: API/Formulation Development, CDMO/CMO, cGMP, Clean Rooms, Clinical Research, CMC, CRO, Drug Development, Early Phase Clinical Trials, Early Phase Drug Development, GMP, GMP Manufacturing, Pre-Clinical, Regulatory, Regulatory Compliance, USP
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Organized by:
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Xtalks |
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Invited Speakers:
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Mindy Findlay, Research Pharmacy Manager, ICON
Corey Ohnmacht, PhD, Director of Bioanalytical and Quality Control Lab Services, ICON
Jeffrey Hinchey, PharmD, Senior Research Pharmacy Manager, ICON
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Deadline for Abstracts:
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2025-11-06
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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