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News|Videos|September 24, 2026
Ask the Expert: Post-Approval Changes
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.
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Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on how to handle post-approval changes in this episode of Ask the Expert. The drug manufacturing process is never static, explains Schmitt, and therefore, companies should anticipate future changes from either production volume, process optimization, or technological innovation. The key question is how much of this can be anticipated and addressed before filing.
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