Clinical Development and Documentation

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

• Good Clinical Practice (GCP)

• Clinical documentation to be created through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.

• Overview of regulatory and clinical guidelines and how to apply these during clinical development.

• Clinical study protocols, reporting study results, benefit-risk assessment, summaries of clinical data and product information (labelling of drugs), which makes up the clinical documentation submitted to health authorities for approval.

• Clinical 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.

• Clinical Advance Therapy Medicinal Products.

• Clinical outcome measures.

Upon completion the student will be able to provide regulatory input to the clinical development programme for a product and 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 the requirements for clinical data to be included in the marketing authorisation application, create product information.