Dear Consulting section members:
If you are interested in being part of a dialog with FDA and with Industry statisticians on topics of relevance to both, you may want to consider attending the FDA/DIA statistics forum. The program is ready for the 2012 FDA/DIA Statistics Forum April 23-25 in DC:
http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=%2fproductfiles%2f27919%2f12008%2Epdf
Including ...
Keynotes:
Lisa LaVange, PhD, Director, Office of Biostatistics, CDER, FDA, and
Robert Hemmings, Statistics Unit Manager, Medicines and Healthcare products, Regulatory Agency (MHRA), UK
Session Topics:
• FDA Guidances: Multiple Endpoints in Clinical Trials and Non-Inferiority Clinical Trials
• Safety assessments during the pre- and post-marketing phases
• Novel approaches to establishing trust in data monitoring committees
• Tailored Therapeutics
• Clinical trial outcome assessments and good measurement science
• Subgroup analysis in clinical trials
• Enrichment designs
Tutorials:
Multiplicity in Clinical Trials taught by Alex Dmitrienko, PhD
Data Monitoring Committees co-taught by David DeMets, Ph.D. and Susan Ellenberg, Ph.D
Please note: to give as many of you as is possible an opportunity "to be part" of this year's meeting, we are also featuring/promoting, a Poster Session and Round Tables!
This is a co-sponsored FDA/DIA meeting designed by FDA and Industry statisticians to talk about the "stuff" we need we need to figure out and know. Please mark your calendars, register (with very special rates for Govt. attendees) and join us in April to think and to learn!
May you and yours have a Great Holiday Season and a Very Happy New Year!
Many regards,
The 2012 FDA/DIA Statistics Forum Steering Committee
Stephen E. Wilson, DrPH, CAPT, USPHS, CDER, FDA (co-chair)
Barry Schwab, PhD, Janssen Research & Development, LLC (co-chair)
Joan Buenconsejo, PhD, CDER, FDA
Christy Chuang-Stein, PhD, Pfizer Inc.
José C. Pinheiro, PhD, Janssen Research & Development, LLC
Estelle Russek-Cohen, PhD, CBER, FDA
Jerald S. Schindler, DrPH, Merck Research Laboratories
Ram C. Tiwari, PhD, CDER, FDA
Joachim Vollmar, MS, International Clinical Development Consultants LLC (European Representative)
Program Manager
Ellen Diegel, DIA