Features
A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Lifecycle Initiative (PQLI®) has worked at the nexus of...
Eli Zavialov, PhD
GlaxoSmithKline
Senior Director
Eli Zavialov, Ph.D., is a Senior Director, CMC Regulatory Affairs at GlaxoSmithKline. In his current role, Eli leads a team of regulatory professionals managing a diverse portfolio of biological products. He is responsible for the development and implementation of effective regulatory strategies, delivery of global dossier submissions, and managing direct agency interface for CMC related aspects. Prior to this role, Eli held positions of increasing responsibility within technical and regulatory groups at Johnson & Johnson, Merck, and Schering-Plough. Eli holds a PhD in organic and bioorganic chemistry from the University of Southern California, and BSc in chemistry from Moscow State University, Moscow, Russia. He joined ISPE in 2019.
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Management of global postapproval chemistry, manufacturing, and controls (CMC) changes is a growing challenge for industry with many issues. ICH Q12 (Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management) is a transformative document shaping global regulatory postapproval submissions that will help alleviate some of these issues.
Features
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances and products (both chemical and biological), drug-device combination products that meet the...