External Lecturer, Department of Pharmacy, University of Copenhagen and Senior Director, Ozack ApS
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.
This course is a part of
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 the clinical development programme for a product and input to clinical teams.
You will gain an overall understanding of what clinical development consists of and thereby contribute to clinical study teams. Furthermore, you will investigate the requirements for getting studies authorized by authorities, interact with global regulators, understand the requirements for including clinical data in the marketing authorisation application, and create product information.
Course content
This course introduces the concept of Good Clinical Practice (GCP), with focus on documentation through all phases of clinical development, from first studies in humans, exploratory studies, confirmatory studies and post marketing studies.
-
You will be taught how early studies are conducted to best support the design of the confirmatory studies (i.e. phase III trials). The design of early studies, will discuss design of pharmacokinetic and pharmacodynamics studies.
-
You will be given an overview of regulatory and clinical guidelines and how to apply these during clinical development.
-
The course will focus on 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.
-
The course introduces regulatory strategy and interaction with health authorities to discuss the clinical development as part of the regulatory process to ensure a successful drug development.
-
Upon completion, you will be able to provide regulatory input to clinical teams, which support global marketing authorisation.
For more details about the course, please refer to the course curriculum.
Course directors on »Clinical Development and Documentation«
Course details for »Clinical Development and Documentation«
Dates and examination
Course dates
4–7 November 2025
The course is available every year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
On completion of the course, you will be able 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
-
explain and discuss how clinical risk assessment can be handled during development
-
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
-
contribute to plans and proposals regarding clinical development and documentation.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens
Master student: 27,184 DKK
Single course: 29,184 DKK
Non-EU/EEA citizens
Master student: 29,584 DKK
Single course: 31,584 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.
More information
All course information is available in the course curriculum:Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel: +45 35 33 60 66