15 November 2024

Labelling as a Driver for Regulatory Strategy

Take the regulatory strategic lead from early on in the research and development phases and throughout the approval and life cycle phases.

Labelling as a Driver for Regulatory Strategy

This course provides you with the necessary competences to prepare, update and optimize regulatory strategies as new internal and external key information arises. You will learn about the roles and responsibilities of regulatory lead professionals in relation to development, approval and the entire life cycle of a pharmaceutical product.

The why – what – when of regulatory strategy

Many strategic choices are made with the aim of optimizing what can be included in the product information. This course will show you the power of Product Information; how it drives the regulatory strategy; and how the right stakeholders involvement at the right time can be a driver for optimal patient access to medicines. 

Establishing a strong regulatory storyline of a product requires competences within chemical manufacturing control, non-clinical, clinical, safety, approval procedures, regulatory science, understanding the health authorities mindset, identification of product competitors and market access criteria. Faster approval of treatments may become a reality with a strategic approach to the processes.

The three central parts of this course are the Product Information driven strategic approaches; understanding the key relevant health authorities mindset; and the involvement of the right stakeholders at the right time. The course contain focus on strategic considerations, opportunities and challenges from early on in the development through the approval and life cycle processes.













You will be able to understand the need for justified documentation based on context rather than assumptions. This scientific approach facilitate sound and transparent regulatory decision-making; enables you to challenge specialists; and argue for the relevance and scientific legitimacy of context-based documentation.

This course enables your company to take the regulatory lead from early in the research and development phases throughout the approval and strategic regulatory life cycle phases. Your company will gain a regulatory professional, who are able to challenge the regulatory systems, supportive legislation and guidelines to ensure a strong story line for health authorities. Thereby preventing delays in drug innovation, approval and in the market access with regard to the regulatory part.






















Course coordinators
Lene Jørgensen

Jesper Kihl
























Course details

Duration: 3 days
Dates: Expected to be offered next time in autumn 2024
Frequency: Only available every second year
Place: University of Copenhagen, Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 10,000 DKK
Single course student: 12,000 DKK

Non-EU/EEA citizens
Master student: 11,500 DKK
Single course student: 13,500 DKK

The fee includes lunch/coffee.
Payment conditions

Level and credit: Master course; 3 ECTS
Examination date: to be announced in the exam plan
Application deadline: 8 weeks prior to course start
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