Program Overview

Program Overview

The University of Copenhagen offers a course in Drug Regulatory Affairs in Drug Development, which is a compulsory course at the Master's Programme in Industrial Drug Development.

Course Description

This course covers all aspects within the pharmaceutical development process of medicinal products, which are subject to various degrees of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety, and Efficacy, as well as Health Authorities' attitudes and requirements, have a great influence on the drug development process and its success. Regulatory affairs professionals deal with these aspects, and knowing this discipline and how to focus the development process and co-operate with the regulatory affairs professionals can be vital for the success of a medicinal product development and the survival of a pharmaceutical company.

Course Content

The contents will cover the role and responsibility for the drug regulatory affairs professionals, how they are involved in the development process, how to co-operate with this function, the pharmaceutical law frame, the application and approval procedures, regulatory strategic issues, how to build up an application for a marketing authorization, variations, incentives, pharmacovigilance, and how to approach the issues of Quality, Safety, Efficacy, and market access from a regulatory point of view.

Learning Outcome

Upon completion, participants are expected to be able to:

• Give an overview of how, when, and with whom regulatory affairs interact with in the drug development process, particularly with focus on quality, safety, efficacy, and market access
• Recognize the different types of applications and application procedures
• Understand the law frame and guidelines within regulatory affairs
• Explain the scientific advice procedure
• Discuss the law frame and guidelines within regulatory affairs
• Understand, interpret, and follow regulatory guidelines
• Apply knowledge of regulatory affairs area in the participant’s working environment

Literature

The syllabus comprises selected EMA guidelines and EC directives, corresponding to approximately 300 pages.

Admission Requirements

Applicants must meet the following criteria:

• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree, or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering, or equivalent
• At least two years of relevant work experience related to the development of medicines
• Proficiency in English

Teaching and Learning Methods

The course will consist of 15-20 lectures over a 5-day period, with time for extensive discussions facilitating active participation by the participant. Group discussions and case stories will be an important part of the course.

Workload

• Class Instruction: 38 hours
• Preparation: 28.75 hours
• Exam: 2 hours
• Total: 68.75 hours

Assessment

The exam is a written assignment, 2 hours, composed of essay questions. The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. All aids are allowed.

Marking Scale

The marking scale is a 7-point grading scale, with external censorship.

Course Information

• Language: English
• Course code: SMIMA1081U
• Credit: 2.5 ECTS
• Level: Part Time Master
• Duration: 5 days
• Placement: Autumn
• Schedule: See course calendar
• Course capacity: 25 participants

Fees

Fees are published on the course webpage and include lunch/coffee. Prices may be subject to change.

Study Board

The study board for the Professional Master's Degree Programmes at The Faculty of Health and Medical Science is responsible for the course.

Contracting Department

The Department of Pharmacy is the contracting department for the course.

Contracting Faculty

The Faculty of Health and Medical Sciences is the contracting faculty for the course.

Course Coordinators

The course coordinators are Lene Jørgensen and Jesper Kihl.