The 4th Annual FDA/DIA Statistics Forum will take place at the Marriott Bethesda North Hotel & Conference Center in Bethesda, MD, including Tutorials April 18 and the Forum April 19-21.
The program will include Special Advisors:
* Robert T. O’Neill, PhD: Director, Office of Biostatistics, CDER, FDA
* Sue-Jane Wang, PhD: Associate Director, Adaptive Design and Pharmacogenomics Office of Biostatistics, CDER, FDA
* Gregory Campbell, PhD: Director, Division of Biostatistics, CDRH, FDA
This forum will include FDA, industry, academia, CROs, and other regulatory affairs professionals to assess current and emerging statistical methodologies and quantitative approaches used to develop evidence of the safety and efficacy of new drug and biologic therapeutic products.
Download PDF showing Workshop Details
FEATURED TOPICS:
* Good Meta-Analyses Practices
* Meta-Analysis to Evaluate Cardiovascular Risks
* FDA Guidance on Non-Inferiority
* Issues Associated with Meta-Analysis for Margin Justification
* Modeling & Simulation for Quantitative Decision Making in Drug Development
* Challenges in Developing Tailored Therapies by Subgroup Identification
* Using CDISC/ADaM to Create Analysis-ready Datasets
* Collaborative Environments for Statistical Methodology Development – The Wiki Way
* Comparative Effectiveness Research
Read your Workshop Details [pdf] to learn more!
CONTACT INFORMATION:
Ellen.Diegel@diahome.org
215.442.6158
Developed by the FDA/CDER Office of Biostatistics & DIA Statistics SIAC
