Pre-Conference Workshop Day

WORKSHOP A: Adapting to Survive the Rapidly Changing Real-World Research Regulatory Environment

Tuesday, October 26, 2021 - 10.00 - 12:30 EDT

The rapidly shifting regulatory environment provides both challenges and opportunities for drug developers. The ability to navigate this environment will provide lucrative opportunities to reduce development costs and gain regulatory approval. This interactive workshop session will provide you with actionable takeaways on:

  • How to anticipate changes from global regulatory agencies on RWE/RWD acceptance
  • Regulatory foundation and framework for RWE studies
  • Bear traps and honey pots – standardizing document management approaches to real-world studies

Workshop Leaders:


Stuart McCully 
Co-Founder                Real World Research Limited


Russell Joyce
Director and Principal Consultant
Heath Barrowcliff Consulting

WORKSHOP B: RWE Applications 2.0 through Federated Machine Learning

Tuesday, October 26, 2021 - 13:30 - 16:00 EDT

With the breadth and depth, volume, and sources of RWD, drug developers are now presented new heights of insights, specifically for precision and personalized medicine. The ability to deploy machine learning and AI will open untapped territories for drug developers. Join this interactive workshop with these actionable takeaways:

  • Leveraging federated machine learning to collect and analyze patient-functional outcomes data in a decentralized manner
  • Understanding the implications of decentralized trials and personalised medicine for collecting mobile patient-functional outcomes data
  • Elucidating the current state of the field regarding federated learning and patient-functional outcomes, including opportunities for further research and engagement

Workshop Leader:

Rachele Hendricks-Sturrup - Duke Margolis

Dr. Rachele Hendricks- Sturrup
Research Director,
Real World Evidence
Duke-Margolis Center
for Health Policy


Sara Jordan
Senior Researcher,
Artificial Intelligence and Ethics
Future of Privacy Forum