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Tuesday, June 21 • 11:00am - 12:00pm
#223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence?

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-533-L04-P ; CME 1.00; RN 1.00

The digital transformation of clinical development poses challenges for regulators. These are being addressed but how far are we on the journey and what are the considerations to ensure that data generated by digital technologies is regulatory grade?

Learning Objectives

Describe opportunities and challenges in using digital health technologies during development for clinical evidence generation; Identify what needs to be considered to ensure that the data generated by these technologies is regulatory grade and supports regulatory decisions.


Max Wegner, PharmD, RPh


Introduction and Closing Remarks
Max Wegner, PharmD, RPh

What Needs to be Considered to Ensure that Data Generated by Digital Health Technologies is Regulatory Grade?
Leonard Sacks, MD

Considerations for Using Digital Technologies in Clinical Development: A Multi-Stakeholder Perspective
Jenny Sharpe, PhD

Solutions for Using Digital Health Technology to Generate Clinical Evidence
Alicia Staley, MBA, MS

avatar for Jenny Sharpe

Jenny Sharpe

Senior Scientific Writer, Centre for Innovation in Regulatory Science (CIRS), United Kingdom
Jenny is currently Senior Scientific Writer at the Centre for Innovation in Regulatory Science (CIRS). CIRS is an independent, academic organisation that provides an international forum for industry, regulators, HTA bodies and other healthcare stakeholders to meet, debate and develop... Read More →
avatar for Leonard Sacks

Leonard Sacks

Associate Director for Clinical Methodology, Office of Medical Policy, CDER, FDA, United States
Leonard Sacks is an Associate Director for Clinical Methodology in the Office off Medical Policy, CDER, FDA, where he has worked on integrating IT opportunities into drug development. He has extensive experience with clinical trials, both as a clinical investigator and subsequently... Read More →
avatar for Alicia Staley

Alicia Staley

Vice President, Patient Engagement, Medidata, a Dassault Systèmes Company, United States
Alicia has over 20 years of experience in software design and information systems management. She has a Mechanical Engineering Degree from Syracuse University and from Boston University with a Masters of Information Systems and an MBA. At Medidata, Alicia works to infuse the patient... Read More →

Tuesday June 21, 2022 11:00am - 12:00pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  09: Regulatory, Session |   03: Data-Tech in Clinical Trials, Session