This course is designed to prepare participants to effectively manage clinical safety issues during clinical development. In this "how to" course, clinical safety guidance information pertaining to drug development will be reviewed and the principles and best practices for capturing and reporting premarketing safety data will be presented. Pertinent information necessary to facilitate the understanding the interactions and functions of Data Safety Monitoring Boards and IRBs will also be covered. Case studies will illustrate solutions pertaining to challenges from preclinical and clinical safety signals that occur during drug development. Interactive exercises will demonstrate risk assessment practices throughout clinical development to optimize label and Phase IV negotiations and identify, assess and manage emerging safety issues.

Key Topics: • Interactive Group Workshops and Case Studies • Using Preclinical Safety to Optimize Clinical Safety Assessments • What do FDA Reviewers Really Want from Industry? • Merging Dose-finding, PK/PD Studies to Profile Phase III Safety Evaluation Needs • Data Analysis and MedDRA • Investigator Brochures and IRBs • Data and Safety Monitoring Boards • Evaluating a Safety Problem Midstream • European Union Clinical Trial Directive and ICH Safety Guidance Review • Handling Difficult Safety Issues