This short course is a combination of theory, guidelines, practical considerations, and real-life solutions for those working in the clinical development environment (pharmaceutical, biotech industry, or CRO). The instructors, with the use of a case study presentation, will provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented.
Who should attend?
This short course is designed for regulatory affairs professionals, drug safety specialists, biostatisticians, medical writers, clinical researchers, project managers, and investigators.
At the conclusion of this course, participants should be able to:
- Discuss how to utilize guidelines and regulatory requirements for clinical trials
- Describe ways to contribute to safety analysis plans
- Discuss the statistical safety analysis process and pitfalls that could occur
- Identify impact of benefit-risk assessment in safety data