Tuesday, February 10, 2009

Sessions selected on Jan 30 Meeting

Update from Jan 30 Organizational meeting:
  • 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:
  1. PK-PD Analysis
  2. Overview of Toxicology/Thorough QTC
  3. Adaptive Design - Theory and Methods
  4. Adaptive Design-Examples
  5. Longitudinal Analysis and missing data
  6. Future Directions in planning safety analysis and risk management
  7. Quantitative Risk /Benefit Assessment
  8. Global Harmonization -Regulatory
  9. Global Harmonization -Statistical
  10. Stat issues in phase I designs
  11. Design Issues in Clinical Trials
  12. Interim Analysis Futility Analyisis
  13. Subgroup Heterogeneity/Adj of covariates
  14. Survival Analysis
  15. Stats Modeling , Simulation for decision Making
  16. Bayesian
  17. Multiplicities/Multiple Comparison
  18. Meta Analysis
  19. Non-Inferiority
  20. Quality of Clinical Programs- Designs/Methodological/Robustness /Data
  21. Biomarker/Genomics/Microarray
  22. Open-source software/global platform
  23. Oncology I - Issues
  24. Oncology II. - Designs and Analysis
  25. Psychiatric Clinical Trials CNS/Insomia
  26. ICH Guidelines/ISS, ISE Anallysis Plans
  27. Communication /Stats Consulting
  28. CMC I
  29. CMC II
  30. Food
  31. Veterinary Medicines I - Design and Analysis
  32. Veterinary Medicines II - Issues
  33. Devices I - Medical
  34. Devices II - Diagnostics
  35. Vaccines

Sunday, February 1, 2009

Abstract Template

Please submit abstract in this format to:
by Feb 27, 2009.

A "Word" template will be mailed to all session organizers.