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 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.
Moreover, 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.
At last, 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.
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.
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience
- Be proficient in English
Find detailed information about the admission criteria.
- Lene Jørgensen, Associate Professor and Head of Studies, Department of Pharmacy, University of Copenhagen, Denmark
- Christina Rindshøj, Senior Director, Leadership and Regulatory Expert, Ozack ApS
Dorte Bjørn Larsen, Senior Regulatory Affairs Manager, Regulatory Policies, Novo Nordisk A/S, Denmark
This course is offered as a compulsory part of the Master of Medicines Regulatory Affairs.
Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
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.
|Dates:||25-28 October 2022|
|Frequency:||Once per year|
|Place:||Atrium, Greater Copenhagen, Denmark
|Course fee:||EU/EEA citizens
Master student: 25,100 DKK
Single course participant: 27,100 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:||30 August 2022|
|Admission:||To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs|