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10008 4th Annual FDA/DIA Statistics Forum
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Title:
4th Annual FDA/DIA Statistics Forum


Date(s) And Time(s):
Apr 18 2010 8:00AM - Apr 21 2010 5:00PM

Location:
Marriott Bethesda North Hotel
5701 Marinelli Road
North Bethesda, MD 20852-2785 

Interest Area(s):
Statistics, Clinical Research, Clinical Safety/Pharmacovigilance, Medical Communications, Regulatory Affairs, Research & Development

Overview:

The FDA/DIA Forum provides a venue to discuss important statistical issues associated with the development and review of therapeutic drugs and biologics. The meeting is intended to be an annual, open dialogue to discuss FDA’s issues, initiatives and guidance – emphasizing the statistical and regulatory challenges.

 

The conference is an opportunity for statisticians, clinicians and other interested professionals from industry, academia, CROs, and government agencies to learn about and assess current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new drug and biologic therapeutic products.

 

We use this opportunity to come together annually in the Washington, DC area to describe important issues, discuss solutions and review progress and problems. We feel that it is important for all stakeholders to examine their roles in this enterprise and ask the hard questions that need to be answered – to develop appropriate, scientific/regulatory consensus regarding our purpose and process.

 

In recent years, thought leaders from government agencies, industry, and academia have discussed:

 

·         Biomarker development and assessments

·         Considerations for specific Guidances, including those for Adaptive

·         Design, Non-inferiority, Multiplicity and Missing Data;

·         Statistical challenges in analyzing safety data such as meta-analytic methods, analysis of rare adverse events, and multiplicity;

·         Current and emerging statistical methodologies and quantitative approaches used to develop evidence of the efficacy and safety of new therapeutic products;

·         FDA’s “Critical Path” initiative and the 2007 Food and Drug

·         Administration Amendments Act – emphasizing the regulatory and statistical challenges associated with innovative approaches to the design and analysis of clinical trials data and the need for new statistical thinking;

·         Best practices for developing appropriate, scientific and regulatory consensus;

·         The impact of regulations and Guidances on statistical practice;

·         Ideas for improving the communication between Industry Statisticians and Reviewers; and,

·         The previous year’s statistical and regulatory “highlights.”



Target Audience:

WHO SHOULD ATTEND

·         Statisticians

·         Clinicians

·         Epidemiologists

·         Drug safety professionals

·         Regulatory and medical communication scientists



Event Code:
10008

Contact Information:
Contact Ellen Diegel at the DIA office by telephone +1-215-442-6158, fax +1-215-442-6199 or email Ellen.Diegel@diahome.org.