Statistics aren’t just for statisticians any more.

Pharm Stats 2008: Confronting Controversy on March 18 & 19, 2008 in Arlington, Virginia is designed as a different kind of statistics conference. Leaving tradition and brain-drain at the door, our expert faculty presenters will:

o       Forego the formulas and long-winded lectures that tend to be the norm with traditional statistics conferences

o       Present dynamic yet succinct 30-minute sessions without overwhelming jargon, perfect for professionals with limited background in statistics

o       Facilitate informative 60-minute break-out personalized group discussions where you can share your experiences and ask your organization-specific questions

o       Participate in a speaker roundtable luncheon where speakers and attendees can break bread and discuss the vital crossroads of the current industry and regulatory environment

Focusing on quality, not quantity, the Institute of Validation Technology worked closely with the Pharm Stats Advisory Committee to tailor a conference experience for pharmaceutical, biopharmaceutical, and medical device professionals impacted by the recent regulatory and industry emphasis on the:

• FDA Process Analytical Technology Guidance (PAT)
• ICH Guidelines including, ICH Q6 on specifications, ICH Q8 on Pharmaceutical Development, and ICH Q9 on Risk Management
• USP Chapter <111>
• Method Comparison, %RSD, Square Root N + 1, and Xbar +-3S

Be a part of this rare opportunity to listen and discuss innovative and cutting-edge viewpoints, including:

• FDA insights of H. Gregg Claycamp, PhD (FDA, CDER) on the role of probability in a ICH Q9 world
  
• Two differing views of the USP Chapter <111> revisions explored by Walter W. Hauck, PhD (USP) and David Lansky, PhD
  
• Revolutionary approach to bulk sampling by Patricia Smith, PhD
  
• Unique perspective on several FDA documents by Steven Kuwahara, PhD

Regardless of your statistical background, you will gain insight and information on these timely topics and make a positive contribution.”

- Lynn Torbeck (Conference Chair),

  Principal Consultant, Torbeck &   Associates