SMIMA1081U Drug Regulatory Affairs in Drug Development

Volume 2014/2015

Please note this is course description is for the study year 2014/2015. For updated information on dates, prices etc. in other semesters please visit

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

The course serves as continuing professional development (CPD) for drug development professionals interested in or working under drug regulation, e.g. employees in QA/QC, CMC, analytical development and pharmaceutical development.

Master’s level (second cycle higher education). Open for freelance students who meet the admission criteria. Compulsory for MIND students, elective for other part-time master's students. (subject to study board approval).


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 in EU, US and outside EU/US, 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 and Efficacy 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 the drug development process, particularly with quality, safety and efficacy
  • Recognize the different types of applications and application procedures available in the EU, US and outside EU/US
  • 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

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

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
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
  • Exam
  • 2
  • Preparation
  • 28,75
  • Total
  • 68,75
2,5 ECTS
Type of assessment
Written examination, 2 under invigilation
The test is composed of essay questions. 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.
Written aids allowed

Calculators are not allowed.
Apart from the standard programs and IT tools listed under The Faculty of Health and Medical Sciences at students will at this exam also have access to use a USB stick (for notes etc.)

Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

10 October 2014

Criteria for exam assesment

Grade 12:

The examinee:

  • demonstrates a well structured presentation with a clear outline providing exact and correct answers.
  • combines convincingly the learned elements.
  • demonstrates with few unimportant deficits aplomb mastering of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various threshold on the way to final market authorisation.

Grade 7:

The examinee:

  • demonstrates a coherent presentation providing understandable unambiguous answers, the great majority of which should be correct.
  • documents a certain overview over the learned elements.
  • demonstrates with minor deficits a firm knowledge of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various thresholds on the way to final market authorisation.

Grade 02:

The examinee:

  • demonstrates a less structured presentation with less precise answers.
  • demonstrates a limited overview ability to combine the learned elements.
  • demonstrates only to a limited extent and with a number of deficits a firm knowledge of relevant terms, principles and guidelines used for preparing relevant documentation for passing the various thresholds on the way to final market authorisation.