Complimentary webinar on the key considerations for delivering an integrated preclinical and clinical abuse potential drug development evaluation that meets EMA and FDA regulatory requirements.
Topics being covered:
• Determining if your CNS-active drug requires abuse potential evaluation
• The reasons for evaluating abuse potential and how scheduling impacts a marketed drug
• The required preclinical and clinical studies and the best timing for their conduct
• The key differences in evaluating abuse potential for EMA and FDA drug submissions
• Strategically planning for abuse potential evaluation and identifying when a waiver may be warranted for certain components
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