Short Courses

Short courses will be held on Wednesday, September 16 for an additional fee of $105 ($110 after August 26) each. Click here for registration information.

2015 FDA/Industry Statistics Workshop Short Course Schedule

8:30 a.m.-12:00 p.m.

SC1: An Overview of Statistical Considerations in Personalized Medicine: Concept and Methodology, Meijuan Li, US FDA

SC2: Handling Missing Data in Clinical Trials, Sonia Davis, University of North Carolina at Chapel Hill; Michael O'Kelly, Quintiles

SC3: Equivalence and Similarity Testing, Shein-Chung Chow, Duke University; Yi Tsong, US FDA CDE

SC4: Introduction to PK/PD Modeling for Statisticians, Yaming Hang, Biogen Idec; Alan Hartford, AbbVie

1:30 p.m.-5:00 p.m.

SC5: Dose Finding in Drug Development: Methods and Implementation, With Focus on MCP-Mod, Frank Bretz, Novartis; Jose Pinheiro, Johnson & Johnson

SC6: Statistical strategies for clinical development of personalized medicines, Cong Chen, Merck

SC7: Bayesian Adaptive Phase I Oncology Trials: Methodology and Implementation, Beat Neuenschwander, Novartis Pharmaceuticals AG; Satrajit Roychoudhury, Novartis Pharmaceuticals

SC8: Designing Observational Comparative Studies Using Propensity Score Methodology in Regulatory Settings, Donald Rubin, Harvard University; Lilly Yue, US FDA/CDRH

***Short course descriptions are available in the online program.