Clinical Development and Documentation

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.

Participants must

• 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.