Date(s) And Time(s):
Apr 18 2010 8:00AM - Apr 21 2010 3:30PM

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:

Learn About and Assess Current and Emerging Statistical Methodologies and Quantitative Approaches to Developing Safe and Efficacious New Drugs and Biologics.

 

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 an annual, open dialogue to discuss FDA’s issues, initiatives and guidances – 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 effi cacy and safety of new drug and biologic therapeutic
products.

 

Participants will have a unique opportunity 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.

 

FEATURED TOPICS
• Good Meta-Analyses Practices
• Meta-Analysis to Evaluate Cardiovascular Risks
• FDA Guidance on Non-Inferiority
• Issues Associated with Meta-Analysis for Margin Justifi cation
• Modeling & Simulation for Quantitative Decision Making in Drug Development
• Challenges in Developing Tailored Therapies by Subgroup Identifi cation
• Using CDISC/ADaM to Create Analysis-ready Datasets
• Collaborative Environments for Statistical Methodology Development – The Wiki Way
• Comparative Eff ectiveness Research</FO

Learning Objectives:
• Discuss innovative statistical solutions to issues associated with the evidence and regulatory review of therapeutic drugs and biologics;
• Describe the application of statistical methodologies and thoughts to the development of new therapeutic biologics and drugs;
• Explain the impact of regulations and Guidances on statistical practice; and
• Discuss ideas for improving the communication between industry statisticians and reviewers.

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.