Cardiovascular Safety in Drug Development: QT, Arrhythmias, Thrombosis, and Bleeding

Date(s) And Time(s):
Apr 11 2010 8:00AM - Apr 13 2010 5:00PM

Location:
Sheraton National Hotel Arlington
900 South Orme Street
Arlington, VA 22204

Interest Area(s):
Clinical Safety/Pharmacovigilance, Clinical Research, Document Management/ eSubmissions, Nonclinical, Quality Assurance/Quality Control, Regulatory Affairs, Research & Development

Overview:

Abstract Submission Guidelines

Please submit all abstracts via email to Rachel Minnick, Program Developer Rachel.Minnick@diahome.org

All abstracts must be received by February 13, 2010

Authors of selected abstracts will be notified by March 13, 2010

Suggested Abstract Topics

(The strongest abstracts have been those with a clear hypothesis and supporting data with a strong scientific design)

Drug Development and CV safety

· Drug-induced increases in CV events

· Myocardial toxicity

· Pharmacogenomics and drug-induced CV injury

· How can we practically assess the negative inotropic potential of new drugs?

· Anticoagulant safety—how to measure it?

Evolving Science of QT/Arrhythmia Assessment

Learning Objectives:
At the conclusion of this conference, participants should be able to:

· Recognize the state-of–the-art approach to performing the thorough QT study, including double-blinding of the positive control agent, the statistical analysis of the positive control, the definition of adequate assay sensitivity, and issues of multiplicity

· Describe how to evaluate drugs for CV risk

· Explain how new preclinical or clinical biomarkers can gain regulatory acceptance;

· Identify how to optimally use preclinical data to assess CV risk

· Discuss the use of automatic QT Mesaurements

· Explain the major issues in clinical CV safety evaluation.

Target Audience:

· Academic scientists

· Industry management

· Clinical project physicians

· Quality assurance directors

· Preclinical/discovery scientists

· ECG safety data managers

· ECG lab and equipment vendors

· Regulatory specialists

For further information, contact Rachel Minnick, Program Developer Phone +1.215.442.6131 | Fax +1.215.293.5904 Rachel.Minnick@diahome.org

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