Jackie Gavin, PharmD

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Amgen
Post-Doctoral Regulatory Affairs Fellow
Jackie Gavin, PharmD, completed her Doctor of Pharmacy at the University of Texas at Austin College of Pharmacy. She was accepted into the Rutgers Pharmaceutical Industry Fellowship Program and paired with the partner company, Amgen. In her current position as a Post-Doctoral Regulatory Affairs Fellow, Jackie has gained hands-on experience working with staff globally in multiple functions across the diverse field of regulatory affairs.

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Figure 1: Redundancies in the postapproval change management process contribute to delayed approval.
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Streamlining Postapproval Submissions Using ICH Q12 & SCDM

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...