This course is designed to provide an understanding of the many details to consider in the design, preparation, and packaging of clinical trial materials within the regulatory framework of disciplined clinical studies. The course encourages interaction and participation through small group case studies and roundtable discussions that emphasize the key concepts underlying the planning, implementation, and logistics of clinical supply projects.


Key Topics
•Techniques that streamline the clinical supply process
•Interrelationships of the clinical supply pharmacist, clinical research associate, medical monitor, regulatory professional, compliance officer, clinical pharmacist and quality assurance auditor
•Current good manufacturing processes (cGMP) and good clinical practices (GCP) concepts applicable to the investigational supply process
•Sponsor obligations during the preparation, use, and return of investigational materials learning objectives.