SFKK18009U  Regulatory Science

Volume 2018/2019
Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

Content

Pharmaceuticals are one of the most regulated products in society. The policies and regulations influencing the availability and use of pharmaceuticals are international, national and local. Regulators and drug developer must make decisions from the earliest preclinical stages through all phases of drug development.

The regulatory framework for medicines is constantly evolving. The system changes in order to adapt to scientific developments; address medical needs; bring medicines to patients earlier (and with better evidence); and also to keep prescribing information up to date. In Regulatory Science we seek to study and evaluate the regulatory system as such in terms of impact on ensuring patient safety, enhancing public health and stimulating the development of medicines.

The aim of the course is to give participants insight into and understanding of Regulatory Science as well as giving the participants a better understanding of the theories and methods available for analysing the effects of regulatory systems and interventions.

Learning Outcome

On completion of the course participants should be able to:

Knowledge

  • Understand the current regulatory system of medicines

  • Understand the political and legal framework of drug regulation

  • Describe the traditional process of drug discovery and development, and relate this to the current regulatory framework

  • Describe various research approaches applied in regulatory science

  • Describe use of strategies and existing data sources for to be used in Regulatory Science research

Skills

  • Identify and conceptualise relevant regulatory science research question and hypothesis, through analysing the scientific literature in context of regulatory systems

  • Identify and apply approaches and methods to address Regulatory Science research questions

  • Identify appropriate data sources, and methods for data extraction and validation, to study a regulatory science research question.

     

Competences

  • Discuss and critique Regulatory Science research and its implications

  • Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public

Background literature on applicable theory and research methods

Scientific literature

Relevant Regulatory Guidelines

A bachelor’s degree in health, natural or technical sciences.
Lectures and teaching in classes (50 hours in total).
Group case work including preparation of written reports and oral presentations as well as smaller individual assignments (100 hours)
Preparation for classes, self-study (56 hours).
Continuous feedback during the course of the semester
Feedback by final exam (In addition to the grade)
Peer feedback (Students give each other feedback)
Credit
7,5 ECTS
Type of assessment
Oral defence
In order to obtain the course certificate the students should:
Participate to a satisfactory level
Submit written work
Take part in group presentation of written work.
Present individual written review
Be able to discuss and critique own and others work
Aid
Written aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To obtain a course certificate the student should be able to:

Knowledge

  • Understand the current regulatory system of medicines

  • Understand the political and legal framework of drug regulation

  • Describe the traditional process of drug discovery and development, and relate this to the current regulatory framework

  • Describe various research approaches applied in regulatory science

  • Describe use of strategies and existing data sources for to be used in Regulatory Science research

Skills

  • Identify and conceptualise relevant regulatory science research question and hypothesis, through analysing the scientific literature in context of regulatory systems

  • Identify and apply approaches and methods to address Regulatory Science research questions

  • Identify appropriate data sources, and methods for data extraction and validation, to study a regulatory science research question.

     

Competences

  • Discuss and critique Regulatory Science research and its implications

  • Effectively communicate the value of Regulatory Science, including priorities and gaps to stakeholders, including colleagues, policy makers, the media, and the public

 

  • Category
  • Hours
  • Lectures
  • 50
  • Course Preparation
  • 56
  • Study Groups
  • 100
  • Total
  • 206