The 16th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2022 (CDER Co-Sponsorship) April 6 - 8, 2022

Forum | Virtual

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• Date: April 6 - 8, 2022
• Day1: Wed, Apr 6
• Day2: Thu, Apr 7
• Day3: Fri, Apr 8

The 16th Annual FDA/DIA Biostatistics Industry and Regulator Forum 2022. The meeting will be held April 6 - 8, 10:00 am – 5:00 pm EST as a virtual event. 

Link to meeting information: 

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.

Contact

If to DIA:
 Barbara Lopez Kunz
Global Chief Executive
    Drug Information Association (DIA)
800 Enterprise Road, Suite 200
Horsham, PA 19044-3595

Copy to:
 Patti Shaughnessy, CMP, DES
        Project Manager
Drug Information Association (DIA)
800 Enterprise Road, Suite 200
Horsham, PA 19044-3595

If to FDA:  
Scott N. Goldie, PhD
Office of Biostatistics, Office of Translational Sciences
Food and Drug Administration
10903 New Hampshire Avenue
Bldg. 21 Room 3557
Silver Spring, MD 20993

Copy to:
Fairouz Makhlouf, PhD
Statistician at Department of Health and Human Services
     Office of Biostatistics, Division of Biometrics VIII, CDER
Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993