Program Overview

Program Overview

The University of Copenhagen offers a course titled "Labelling as driver for Regulatory Strategy" as part of its Master of Medicines Regulatory Affairs (MRA) program. This course is designed to provide students with the necessary competences to prepare and optimize regulatory strategies for pharmaceutical products.

Course Description

The course focuses on the role and responsibilities of a regulatory lead professional in the pharmaceutical industry, emphasizing the development, approval, and life cycle of a pharmaceutical product. It covers topics such as chemical manufacturing control, non-clinical, clinical, safety, approval procedures, regulatory science, identification of product competitors, and market access criteria.

Learning Outcomes

After completing the course, participants will be able to:

• Explain and describe the roles and responsibilities of a regulatory lead professional in the pharmaceutical industry
• Identify what a regulatory strategy should contain, including general and context-specific content
• Explain and describe why product information is a key driver for approval and market access
• Explain and describe when to use patient-reported outcomes, patient and health technology assessment aspects in product information
• Explain and describe various types of scientific advice in e.g., EU, USA, Japan, and China during medicines development and throughout the entire life cycle

Course Details

• Language: English
• Course Code: SMRM18008U
• Credit: 3 ECTS
• Level: Part-time Master
• Duration: 3 days
• Placement: Spring and Autumn
• Schedule: 3 days full-time
• Course Capacity: 35

Teaching and Learning Methods

The course will be taught through lectures, group work, and self-study of course literature.

Workload

• Lectures: 18 hours
• Preparation: 30 hours
• Theory Exercises: 8 hours
• Exam: 25 hours
• Total: 81 hours

Assessment

The course will be assessed through a written assignment, which will be evaluated based on the following criteria:

• Identify what a regulatory strategy should contain, including general and context-specific content
• Explain and describe why product information is a key driver for approval and market access
• Explain and describe when to use patient-reported outcomes, patient and health technology assessment aspects in product information
• Explain and describe various types of scientific advice in e.g., EU, USA, Japan, and China during medicines development and throughout the entire life cycle

Study Board and Contracting Department

The course is offered by the Study Board for the Professional Master's Degree Programmes at the Faculty of Health and Medical Sciences, with the Department of Pharmacy as the contracting department.

Course Coordinators

The course coordinators are Lene Jørgensen and Jesper Kihl.