29 October 2024

Clinical Development and Documentation

Learn how to create a regulatory strategy plan for the clinical development of a medicinal product from phase I to IV. Upon completion, you will be able to provide regulatory input to clinical teams, which support global marketing authorisation


This course gives you knowledge within the fields of clinical documentation needed to support global marketing authorisations.  Upon completion, you will be able to provide regulatory input to clinical teams. 

You will have an overall understanding of what clinical development consist of, and thereby contribute to e.g. clinical study teams. Furthermore, 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.






This course will provide you with the ability to 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, and explain and discuss how clinical risk assessment can be handled during development.

You will learn to create, analyse and evaluate a regulatory strategy plan for the clinical development of a new medicinal product, and evaluate the possibilities and consequenses of the clinical development plan on the desired label.

You will be able to contribute to plans and proposals with regard to clinical development and documentation.














  • Christina Rindshøj, External Lecturer, Senior Director, Leadership and Regulatory Expert, Ozack ApS
    Dorte Bjørn Larsen, External Lecturer, Senior Regulatory Affairs Manager, Regulatory Policies, Novo Nordisk A/S, Denmark















Course details

Duration: 4 days 
Dates: 29 October - 1 November 2024
Frequency: Once per year
Place: Atrium, Greater Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 26,472 DKK
Single course participant: 28,472 DKK

Non-EU/EEA citizens
Master student: 28,872 DKK
Single course participant: 30,872 DKK

Fee includes course materials and meals during the days and a networking dinner the first evening. If textbooks are required, it must be purchased by the participants.

Payment conditions
Level and credit: Master course; 4 ECTS
Examination date: Please consult the exam schedule
Application deadline: 17 September 2024
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs

Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum