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DIA/FDA Biostatistics Industry and Regulator Forum

DIA Your Way! Join us virtually from the comfort of your home/office April 6-8 or watch later at a time that works for you. This event provides access to the materials for a full two months!

Agenda

Day 1 Mar 29, 2022

10:00 AM — 2:00 PM Design, Analysis and Evaluation of Confounding Bias Using RWD

Day 2 Apr 01, 2022

10:00 AM — 2:00 PM Practical Bayesian Approaches in Healthcare: Industry and Regulatory Perspectives

Day 3 Apr 06, 2022

10:00 AM — 10:45 AM Welcome and Opening Remarks and Keynote: Estimating Per-protocol Effects: Randomized Trials Analyzed like Observational Studies
10:45 AM — 11:00 AM Break
11:00 AM — 12:30 PM Session 1: Advancing Decentralized Clinical Trials in Drug Development: Challenges, Opportunities, and Future Directions
12:30 PM — 1:30 PM Break
1:30 PM — 3:00 PM Session 2: Synthetic Controls and Causal Inference
3:00 PM — 3:15 PM Break
3:15 PM — 4:45 PM Session 3: Dose Optimization in Oncology: Finding the “Right” Dose for Patients

Day 4 Apr 07, 2022

10:00 AM — 11:30 AM Session 4: Challenges in COVID-19 Vaccine Development for Adults and Pediatrics: A Journey from Clinical Trials to Real-World
11:30 AM — 11:45 AM Break
11:45 AM — 1:15 PM Session 5: Artificial Intelligence (AI) and Machine Learning (ML) in Drug Development
1:15 PM — 2:15 PM Break
2:15 PM — 3:15 PM Session 6: DIA Data Science and Statistics Community Meeting Discussion: Yes, You Can Use R in Regulatory Submissions
3:15 PM — 3:30 PM Break
3:30 PM — 5:00 PM Session 7: Complex Innovative Design Pilot Program

Day 5 Apr 08, 2022

10:00 AM — 11:30 AM Session 8: Digital Health in Clinical Development
11:30 AM — 11:45 AM Break
11:45 AM — 1:15 PM Session 9: Understanding Logistical and Regulatory Barriers to Using Real-World Data in New Drug Applications or Supplements
1:15 PM — 1:45 PM Break
1:45 PM — 3:15 PM Session 10: Statistical Leaders Town Hall
3:15 PM — 3:30 PM Break
3:30 PM — 4:00 PM Challenges and Opportunities for the Quantitative Sciences in Medical Product Development and Evaluation
4:00 PM — 4:15 PM Closing Remarks

Contact us

Registration Questions?

Send Email
1.888.257.6457

Preconference Short Courses

Short Course: Design, Analysis and Evaluation of Confounding Bias Using RWD

Short Course: Practical Bayesian Approaches in Healthcare: Industry and Regulatory Perspectives

Additional Information

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