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Safety Assessment of Serious Adverse Events in CNS
Strategies for Predicting, Monitoring and Reporting Abuse and Addiction Potential, Seizure Liability and Suicidality
October 21 - 22, 2010
Vienna , VA
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CBI is proud to expand on its drug safety series with the inaugural Safety Assessment of Serious Adverse Events in CNS.  During various stages of the pre-clinical and clinical development process, experimental drugs are frequently found to produce adverse CNS side effects.  While such findings do not often result in immediate discontinuation of a drug’s development it is important to have procedures in place to predict, monitor and report serious adverse events such as abuse and addiction potential, seizure liability and suicidality.

Conference Highlights Include:

  • Suicidality Monitoring in Clinical Trials – Overview of the Columbia Suicide Severity Rating Scale (C-SSRS)

  • Novel Approaches in Pre-clinical Seizure Detection and Prediction Using EEG

  • FDA Draft Guidance for Industry on Abuse Potential Assessment of New Drugs – Relevant Adverse Events Analysis in Clinical Trials 

  • Investigating CNS Serious Adverse Events Associated With ADHD Treatments

  • Safety Evaluation of SSRIs and Other Antidepressants


Sponsors/Exhibitors:

 

   
   
   
   


For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com.

 
Featured Speaker
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Michael Klein, Ph.D.,
Director, Controlled Substance Staff, Center for Drug Evaluation and Research,
U.S. Food and Drug Administration

 
 
 
 
 
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