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Marketed pharmaceutical medicines constantly evolve throughout their lifecycles – new indications, improved formulations or packaging, updated manufacturing methods, validity period extensions, labeling updates and more.

With increasing global regulatory requirements, maintaining compliance of the products in your portfolio is essential to your right-to-operate.

Detailed planning and proper tracking of lifecycle management (LCM) across all relevant geographies are key to ensuring the full value of your products, helping you to avoid duplicative activities, reduce non-compliance risks and efficiently manage your regulatory expertise.

In this webinar, participants will build a better understanding of:

    • Product lifecycle strategies and key corresponding regulatory strategies

    • Effective global LCM planning including developing and maintaining timelines to optimize product extensions
    • Benefits and payback of appropriate LCM tracking tools
    • The importance of CMC regulatory compliance in the context of LCM, especially manufacturing site changes
    • Lifecycle management for divestments and acquisitions

Please join us to learn more about how to optimize your products and portfolio -- across the entire span of their regulatory life – to unleash full product value.

Speaker:

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Christina Bodurow, Ph.D.

Vice President, Global Regulatory Affairs

IQVIA

Dr. Christina (Chris) Bodurow received her Bachelors in Science from Kalamazoo College, and her Ph.D. in Organic Chemistry from Princeton University. Chris is currently Vice-President, Global Regulatory Affairs, in the Data Sciences, Safety and Regulatory Division at IQVIA. Chris’ prior experience includes 33 years at Eli Lilly and Company. She held responsibilities including Senior Director of External Sourcing in the Medicines Development Unit (MDU), Chief Operating Officer (COO), Product Research & Development (CMC component of LRL), as well as global R&D Operations Leader for the Prozac and Xigris Product Teams. Chris Bodurow has served in a number of professional and community volunteer roles, including on the Board of Directors of the American Chemical Society, the Chemistry Advisory Board for Princeton Chemistry, the Board of Directors of the Indianapolis Symphony Orchestra and the Kalamazoo College Board of Trustees.

Hosted by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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