Kara Follmann, PhD

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Pfizer
Executive Director for Anti-Infectives
Kara Follmann, PhD, is the Executive Director for Pfizer’s Anti-Infectives, Hospital, Global Brands and Sterile Injectable CMC portfolio within Pfizer Global Regulatory Sciences and is based in Peapack, New Jersey. She has more than 20 years of increasing responsibility in the pharmaceutical industry, including extensive experience developing and implementing science- and risk-based approaches across the end-to-end product life cycle in support of innovative and established small molecule and biologic products across a broad variety of dosage forms, including combination products.

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An Evaluation of Postapproval CMC Change Timelines
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An Evaluation of Postapproval CMC Change Timelines

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...