Roundtable Luncheon Discussions
Tuesday, September 23, 2014
11:45 am - 1:00 pm

To aid productive discussion, roundtables will take place in a number of rooms, organized by general theme/topic on Tuesday, September 23, 2014. Each table will accommodate 8 to 10 participants. Plated lunches will be available for all attendees. During the registration process, participants will be prompted to select a specific discussion table of interest, where they will then be served their lunch. Lunch Only tables will also be made available for those attendees that wish to have lunch without participating in a specific roundtable discussion.

If you are interested in participating as a roundtable speaker please submit your roundtable discussion proposal online before March 11, 2014 11:59pm EST.

Enter your name and contact information as the Organizer and also as the Author. When you submit a roundtable topic you will be automatically considered the roundtable leader. Therefore you cannot submit more than one roundtable discussion topic.

It is recommended to add to the abstract 1-2 key questions for participants to prepare for a productive discussion. Optionally, to encourage lively discussion, we suggest 2 co-leaders for the roundtable luncheon proposal, one from the FDA and one from industry or academia.

Roundtables are organized in the following broad topics:

  • Adaptive Design
  • Bayesian Analysis
  • Benefit Risk
  • Biomarkers
  • Chemistry, Manufacturing and Controls and Biosimilars
  • Devices and Diagnostics
  • DSMB/Advisory Committee
  • Meta Analysis
  • Methodology
  • Missing Data
  • Modeling and Simulations
  • Multiplicity/Multiregional Clinical Trials/IA
  • Non-Inferiority
  • Observational Studies
  • Oncology
  • Patient Reported Outcomes
  • Quality/Validation
  • Regulatory Topics/Guidances
  • Safety
  • Subgroup Analysis
  • Therapeutic Area Specific Topic
  • Vaccines/Veterinary

**A full list of discussions within each topic will be available in the online program after roundtable selections have been made.

Submit/Edit Abstract