- 35 sessions were voted in for further considerations.
- Session organizers were identified.
- Each group of session organizers will submit a formal abstact (due Feb 27) to steering committee for final session selection.
If you have a talk you'd like to submit for consideration in any of these sessions, please contact us at fdaindustry2009@gmail.com and we will forward it to the appropriate session organizers
Sessions selected based on a vote:- PK-PD Analysis
- Overview of Toxicology/Thorough QTC
- Adaptive Design - Theory and Methods
- Adaptive Design-Examples
- Longitudinal Analysis and missing data
- Future Directions in planning safety analysis and risk management
- Quantitative Risk /Benefit Assessment
- Global Harmonization -Regulatory
- Global Harmonization -Statistical
- Stat issues in phase I designs
- Design Issues in Clinical Trials
- Interim Analysis Futility Analyisis
- Subgroup Heterogeneity/Adj of covariates
- Survival Analysis
- Stats Modeling , Simulation for decision Making
- Bayesian
- Multiplicities/Multiple Comparison
- Meta Analysis
- Non-Inferiority
- Quality of Clinical Programs- Designs/Methodological/Robustness /Data
- Biomarker/Genomics/Microarray
- Open-source software/global platform
- Oncology I - Issues
- Oncology II. - Designs and Analysis
- Psychiatric Clinical Trials CNS/Insomia
- ICH Guidelines/ISS, ISE Anallysis Plans
- Communication /Stats Consulting
- CMC I
- CMC II
- Food
- Veterinary Medicines I - Design and Analysis
- Veterinary Medicines II - Issues
- Devices I - Medical
- Devices II - Diagnostics
- Vaccines