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Virtual

Apr 06, 2022 10:00 AM - Apr 08, 2022 5:00 PM

(US Eastern Standard Time)

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

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DIA/FDA Biostatistics Industry and Regulator Forum

Agenda

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