CMC Changes & Regulatory Interaction
Source: Cytiva
What specific biopharma CMC changes invite regulatory scrutiny? Pretty much all of them. In this segment of the Bioprocess Online Live event Regulatory Harmonization Meets CMC Realities, Steffi Pluschkell, Ph.D., former Pfizer Head of Business Strategy and Operations and current CEO of InScope Coaching & Consulting, Bioprocess Online Chief Editor Matt Pillar, and Alira Health Senior VP of CMC Steven Chamow, Ph.D. discuss the most common—and where many biopharma leaders get tripped up.
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Cytiva
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