- March 29 - 31, 2023
The meeting will be held March 29 – March 31, 2023, as a virtual event DIA/FDA Biostatistics Industry and Regulator Forum.
Goals and Objectives:
- Explore and implement innovative statistical solutions to issues associated with the evidence and regulatory review of therapeutic drugs and biologics.
- Describe the application of statistical methodologies and thinking to the development of new therapeutic biologics and drugs.
- Assess the impact of regulations and guidance on statistical practice.
- Discuss ideas for improving the communication between industry statisticians and reviewers.
Who Should Attend:
The workshop will appeal to statisticians in, or consulting for, the biopharmaceutical industry, clinicians, epidemiologists, drug safety professionals, regulatory and medical scientists, and other stakeholders interested in recent statistical issues in clinical research.
If to DIA:
SVP & Managing Director for DIA Americas
Drug Information Association (DIA)
800 Enterprise Road, Suite 200
Horsham, PA 19044-3595
Americas@DIAglobal.org | tel:1-888-257-6457
If to FDA:
Scott N. Goldie, PhD
Office of Biostatistics, Office of Translational Sciences
email@example.com | tel: 301-796-2055
Fairouz Makhlouf, PhD
Statistician at Department of Health and Human Services
Office of Biostatistics, Division of Biometrics VIII, CDER
firstname.lastname@example.org | tel: 240-402-3869