Very few professionals working in clinical research or drug development have the opportunity to follow a clinical trial from design to closure. This seminar provides a broad overview of key aspects of conducting a clinical trial from the point of Good Clinical Practice (GCP).
This course provides an overview of the regulatory systems currently in operation and an understanding of the rationale for those systems.
Starting with the history of medicinal product regulations and the need for ethics, the course explains the regulatory aspects of clinical development and the purpose and impact of different regulations on the conduct of clinical research. Practical applications of GCP are explored including informed consent and safety reporting.