Module C: The Clinical part of the dossier

The third module is on clinical studies. We will discuss the clinical part of the Common Technical Document, e.g. how clinical development plans are made; how to interpret clinical data; and how to make a benefit-risk analysis.

Learning objectives

After this module you will be able to:

  • Understand the processes for a clinical trial application and the changes that will be implemented in the new clinical trial regulation.
  • Draft an outline of the full clinical development plan (CDP) of a new medicinal product, from first human studies up to phase III studies.
  • Critique an existing CDP with solid arguments.
  • Understand and work with clinical data reports, with a basic knowledge of data management techniques and statistical analysis methods.
  • Understand what sort of benefit-risk assessment tools can be applied to clinical data.
  • Outline the specific clinical needs for pediatric drug development. 
  • Translate clinical study results into a regulatory review submission.
  • Understand how regulatory authorities assess clinical studies.