SMIMA1081U Drug Regulatory Affairs in Drug Development

Volume 2026/2027
Education

This course is a compulsory course at the Master's Programme in Industrial Drug Development.

 

Content

All aspects within the pharmaceutical development process of medicinal products are subject to various degree of regulation. The pharmaceutical law frame, guidelines covering Quality, Safety and Efficacy as well as Health Authorities' attitudes and requirements etc. have a great influence on the drug development process and the success of it. Regulatory affairs professionals deal with these aspects. 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 so the survival of a pharmaceutical company.
 

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 issue, 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:

Knowledge:

  • 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

 

Skills:

  • Explain the scientific advice procedure
  • Discuss the law frame and guidelines within regulatory affairs

 

Competencies:

  • Understand, interpret and follow regulatory guidelines
  • Apply knowledge of regulatory affairs area in the participant’s working environment

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

The course will consist of 15-20 lectures over a 5-day period. Each lecture will leave time for extensive discussions facilitating active participation by the participant. Group discussions and case stories will be an important part of the course.
  • Category
  • Hours
  • Class Instruction
  • 38
  • Preparation
  • 28.75
  • Exam
  • 2
  • Total
  • 68.75
Oral
Collective
Credit
2.5 ECTS
Type of assessment
Written assignment
Type of assessment details
The test is composed of essay questions in Digital Exam platform (DE) over 2 hours. The purpose of the examination is to test that the examinee has achieved the expected learning outcomes. The percentage of items on the test devoted to a particular topic will roughly correspond to the emphasis given the topic in teaching of the course, and as implied in the general course objectives and content.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

See exam schedule.

Re-exam

Same as ordinary.

Criteria for exam assesment

To achieve a grade of 12, the student must be able to:

Knowledge:

  • 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

 

Skills:

  • Explain the scientific advice procedure
  • Discuss the law frame and guidelines within regulatory affairs

 

Competencies:

  • Understand, interpret and follow regulatory guidelines