Overview:
Pharmacology, Abuse Liability, and the Role of Surveillance
Insufficient attention to pharmacology, abuse liability and surveillance data during premarketing can delay approval of CNS drugs because they can raise issues related to controlled substance scheduling and risk management/REMS in addition to the issues considered in any new drug application. This webinar will discuss why pharmacology, abuse liability testing, and the role of surveillance should be considered when developing your preclinical testing strategy
WEBINAR TOPICS
· How to develop a program of preclinical and clinical studies related to abuse potential
· Appropriate interpretation of data to facilitate FDA decision making
· Conducting studies for inclusion in the NDA submission package
· Factors likely to be considered by FDA in determining its scheduling recommendations and risk management or REMS requirements
Learning Objectives:
LEARNING OBJECTIVES
At the conclusion of this webinar, participants should be able to:
· Identify the key determinants of an appropriate program of preclinical and clinical studies related to abuse potential,
· Recognize how factors such as selection of comparison drug, dose selection, and study parameters can influence interpretation of results by FDA,
· Discuss what studies should be conducted for inclusion in the NDA submission package,
· Discuss how diverse public health, chemistry and pharmacological, clinical and public health relate factors are likely to be considered by FDA in determining its scheduling recommendations and risk management or REMS requirements.
Target Audience:
Professionals involved in:
· Regulatory Affairs/Policy/Drug or Device Approval/GRP
· Research & Development/Strategic Issues
· Clinical Safety/Pharmacoepidemiology/Pharmacovigilance
· Pharmacology
· Pharmacokinetics/Metabolism/Pharmacodynamics
· Nonclinical Safety & Efficacy/Toxicology
IACET: The Drug Information Association (DIA) has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 8405 Greensboro Drive, Suite 800, McLean, VA 22102. DIA is authorized by IACET to offer .2 CEUs for this program.
