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Drug Safety Regulatory Requirements

Learn more about pharmacovigilance harmonization initiatives and regulatory requirements in the US and EU.

Authors

Kenneth  Lipetz, MD, PHD, MBA, MSC

Kenneth Lipetz, MD, PHD, MBA, MSC

Associate Director, PV Ops – PM, Moderna, United States

Kenneth J Lipetz, PhD, MBA, HCLD is currently the Associate Director, PV Ops – PM at Moderna, Inc. Prior to joining Moderna, he had been with Eli Lilly and Company for over 23 years, Ken has had a number of key strategic, technical and administrative roles in Clinical PM, Clinical Data Management, Data Privacy, Drug Safety, Pharmacovigilance and Drug Development. Ken is also a Certified Lean/Six Sigma Black Belt working on multiple process improvement projects.

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