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Mergers and acquisitions (M&As) play a fundamental role in the growth strategies of most pharmaceutical companies. In 2019 the industry saw a record-breaking 1,276 M&A deals totaling $411 billion, and despite the global pandemic, 2020 divestment and acquisition deals continue to close. In bringing these deals to fruition, the role of regulatory has become increasingly important. Companies must ensure compliance with local legislation and conformance with global requirements—which typically involves highly challenging timelines. Key to success of these license transitions is navigating regulatory obstacles and cross-functional interdependencies that are inevitably present.

The goal of this webinar was to help participants develop a better understanding of:

  • The regulatory transfer process and key interdependencies
  • Pitfalls and complexities that surround license ownership transfers
  • Regulatory do's and dont's for achieving successful transitions

Learn how to optimize your regulatory expertise to solve these challenges and meet local and global requirements, thus effectuating swifter, more seamless transitions.


Speakers:

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Dr. Christina Bodurow

Vice President, Global Regulatory Affairs

Data Sciences, Safety and Regulatory

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.

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Cecile Riboud

Senior Director Europe

Integrated Global Compliance

IQVIA


Cecile is currently responsible for IQVIA’s Integrated Global Compliance in Europe, designing solutions for safety, regulatory and quality compliance. She has over 17 years of life sciences experience across Scientific Information Management, Global Regulatory Affairs and support for Mergers and Acquisitions. Having worked for pharmaceutical groups and consulting and technology companies in Europe, Cecile has an excellent understanding of the pharmaceutical and MD-IVD industry. She has held global leadership positions, leading large global programs and teams of experts. Prior to joining IQVIA, Cecile worked at a well-known regulatory consulting firm in Germany, where she served as acting deputy head of an office totaling 60 regulatory consultants and led global projects involving 70 regulatory consultants worldwide. She was responsible for client delivery of Regulatory Outsourcing Programs. During her career she led regulatory and clinical workstreams of company integration and portfolio acquisition & divestment projects, for a total of over 20,000 licenses transferred. Cecile holds an M.Sc. in Analytical Sciences from the University of Strasbourg, France and an Executive MBA from EMLyon Business School, France – Shanghai, China.


Moderated by

Maire Gerrard

Custom Content Writer

Informa Pharma Intelligence

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