ParagonRx® | Minimize Risk and Optimize Use

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• FDA Draft Guidance for Industry on Abuse Potential Assessment of New Drugs – Relevant Adverse Events Analysis in Clinical Trials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