Video Recap - Regulatory Agility: The Intersection of AI and QARA

On July 23, 2024, regulatory compliance professionals from large and small medical device manufacturers, drug sponsors, law firms and Big Tech gathered in Boston to discuss AI’s influence on quality assurance and regulatory affairs (QARA) at a private event hosted by IQVIA Technologies.

The day consisted of 3 panels full of industry experts including:

  • Carlos Lugo, Vice President of Global Product Safety & Surveillance, Philips
  • Erdit Gremi, Director Regulatory Affairs, Philips
  • Rajesh Mirsa, Principal, Life Sciences Quality and Regulatory Services Leader, KPMG LLP
  • Denise Meade, Healthcare and Lifesciences Technology Leader, Microsoft
  • Don Soong, Senior Director and General Manager, Quality Management Solutions, IQVIA Technologies
  • Alex Denoon, Partner, and Head of Life Sciences and Regulatory Team, Bristows LLP
  • Irina Erenburg, CEO, AVAVA, Inc.
  • Sara Fairfield, Associate Director, Regulatory Affairs, AbbVie
  • Christopher Escobedo Hart, Partner, Co-Chair, Privacy and Data Security Group, Foley Hoag LLP
  • Daniel DeFranco, Director of Quality in Medical Device Manufacturing, Boyd Biomedical, Inc
  • Mike King, Senior Director, Product Strategy, IQVIA
  • Sean McCarthy, VP of Regulatory Affairs, YourBio Health
  • Deepika A. Lakhani, PhD, Senior Vice President, Chief Regulatory & Quality Officer, Lucid Diagnostics
  • Sujat Sukthankar, Founder & CEO, RPD Advisors
  • Krystin Meidell, Director, Global Regulatory Strategy, Combination Products, AbbVie
  • Scott Kaplan, Deputy General Counsel, Baxter International Inc.
  • Lori Ellis, Head of Insights, BioSpace (Moderator)

The BioSpace Insights teams performs research and analysis on industry trends for BioSpace and clients, producing industry reports, podcasts, events and articles.
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