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Labelling as 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.
This course is a part of
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.
Course content
- Target Product Profile, Core Company Data Sheet, Product Information and Regulatory Intelligence
- Intellectual property rights - when does various scenarios matters regulatory vice,
- Regulatory strategy – Get your message through
- Patient reported outcomes, health economics and market access factors - regulatory, strategic relevance
- Patient involvement and perspectives in Product Information
- Industry and health authority aspects on real world data and real world evidence
If I ever want to go into a leadership role, this course will be really helpful for me, since it allows me to better understand how market access and regulatory affairs interact with each other.
Course Directors on Labelling as Driver for Regulatory Strategy
Course details for Labelling as Driver for Regulatory Strategy
Dates and examination
Course dates
22-24 October 2024.
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
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.
Admission criteria
Innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
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.
Tuition fees
EU/EEA citizens
Master student: 11,250 DKK
Single course participant: 12,250 DKK
Non-EU/EEA citizens
Master student: 13,050 DKK
Single course participant: 14,050 DKK
The fee includes lunch/coffee.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66