Course description

Content

The student will obtain knowledge within the fields of clinical documentation needed to support global marketing authorisations. This includes:

Understanding Good Clinical Practice (GCP)
Documentation to be created through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.
Clinical study protocols, reporting study results, benefit-risk assessment, summaries of clinical data and product information ,specifically labelling of drugs, which makes up the clinical documentation submitted to health authorities for approval.
Regulatory strategy and interaction with health authorities to discuss the clinical development as part of the regulatory process to ensure a successful drug development.
The design of early studies, will discuss design of pharmacokinetic and pharmacodynamics studies. The course will discuss how early studies are conducted to best support the design of the confirmatory studies (i.e. phase III trials). The global nature of medicinal product development will be explained and used in model workshops.
Selection of the parameters to be investigated in clinical trials are an important part of drug development, and must be based on the objective of the trials. When these items are in place, the design can be outlined and analytical methodologies described.
Insight into statistical methodologies and different models for clinical trial design.

Upon completion the student will be able to provide regulatory input to clinical teams. The student will have an overall understanding of what clinical development consist of, and thereby contribute to clinical study teams, investigate the requirements for getting the studies authorised by authorities, interact with global regulators and eventually put together the clinical sections of a marketing authorisation application, create product information and vary the documentation during lifecycle of the medicinal product.

Learning Outcome

After completing the course the student is expected to be able to:

Knowledge

Explain and discuss the required clinical documentation for a marketing authorisation application (MAA)
Explain and identify the principles of clinical development from phase I to IV for both small molecules and biopharmaceuticals
Explain and discuss how clinical risk assessment can be handled during development

Skills

Create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product
Evaluate the possibilities and consequences of the clinical development plan on the desired label

Competencies