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Registries and Real World Evidence Studies for Regulatory

Purposes, Including the Role of Technology and AI 

May 20, 2026 | 12:00 - 1:00 PM EST 

Zoom Link: Click here

Meeting ID: 939 4023 1369 

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WEBINAR OVERVIEW:

Registries and other observational studies have long been seen as critical tools for generating real-world evidence—but traditional approaches have struggled to balance rigor, efficiency, and scalability. High profile failures of ‘off-the-shelf’ datasets for regulatory purposes underscores that not all real-world data is created equal. At the same time, AI and automation are delivering the ability to manage very large-scale studies cost-effectively and very small studies with decentralized tools.    

Join OM1, Hologic and Novartis for a discussion on how AI is transforming the design and execution of real-world evidence studies for regulatory purposes today. 

 

Through case examples, we’ll explore how AI-powered methods are: 

  • Optimizing patient identification, tapping into extensive real-world networks to reach hard-to-find populations. 
  • Providing patient-mediated tools for rare populations and to enhance long-term follow-up.
  • Streamlining data acquisition and endpoint determination with automated processing of structured and unstructured data.
  • Building rigor, validation traceability and auditability into these programs. 


By attending this webinar, participants will:

  1.  Understand the range of regulatory use cases for registries and real-world evidence studies.
  2. Learn the regulatory requirements for ‘fit-for-purpose’ and traceable data.
  3. Explore how automation, AI and decentralized technologies can reduce patient burden, increase site satisfaction, limit costs and meet regulatory rigor.
  4. Hear case studies ranging from pre- to post-approval and those for dozens of patients to hundreds of thousands, each designed to use validated technologies from the ground up. 
 
 

SPEAKER PROFILES:

  •  Rich Gliklich, MD, CEO - OM1

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Dr. Richard Gliklich, MD is the founder of OM1, Inc. Previously, he was founder and CEO of Outcome, which he led from inception through its acquisition by Quintiles. Dr. Gliklich is well known in the areas of registries, outcomes and analytics. He is senior editor of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook "Registries for Evaluating Patient Outcomes: A User's Guide” and the PI for the Outcomes Measures Framework, which focuses on standardization of outcomes measurement. He has led several key national and international efforts focused on evaluating the safety, effectiveness, value and quality of healthcare. Dr. Gliklich also holds several patents for both health outcomes systems and medical devices. Dr. Gliklich is a graduate of Yale University and Harvard Medical School and a former Charles A. Dana Scholar at the University of Pennsylvania. He is also a surgeon and the Leffenfeld Professor at Harvard Medical School. 

 

  •  Anne F. Rositch, PhD, MSPH,
    Senior Director, Health Outcomes and RWE - Hologic

     

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Dr. Anne Rositch is the Senior Director of Health Outcomes and Real World Evidence at Hologic, a women’s health diagnostics company. As part of the Medical and Scientific Affairs team, her research focuses on the adoption and impact of diagnostic technologies for women’s cancers globally with a strong focus on breast and cervical cancer. She has used real world evidence across many research settings from adoption of new technologies to surveillance and regulatory submissions.  Dr. Rositch received her PhD in Epidemiology from the University of North Carolina at Chapel Hill, and completed a post-doctoral fellowship at the Johns Hopkins Bloomberg School of Public Health where she was on faculty for over 10 years prior to joining Hologic.

 

  •  Julie Mouchet, PhD
    Global Director, Evidence Generation and RWE - Novartis