SMRM18006U  Drug Regulatory Science

Volume 2018/2019
Education

This course is a compulsory course at Copenhagen University's Master of Medicines Regulatory Affairs (MRA).

 

See course calender for course dates

 

This course is compulsory at the 2018-curriculum

The course is open to single course students and students from other master's programmes.

Content

The course will enable the students to impact discussions on strategic regulatory decisions, and to critically reflect and discuss previously obtained knowledge about guidelines and regulations for clinical development of medicine. 

Regulatory science research will set the foundations for class discussion centred around research methodology and methods, identification of data sources, and interpretation of research results.

The course will centre around 3-4 regulatory science research topics such as, patient involvement in drug development, benefit-risk assessment or accelerated approval pathways. During the course, the students will also be introduced to both qualitative and as quantitative research methods in regulatory science. 

 

 

Learning Outcome

After this course, the student will be able to

Knowledge

  • Describe various research approaches applied in Drug Regulatory Science

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

Skills

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

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

  • Identify appropriate data sources, and methods for data extraction and validation, to study a Drug Regulatory Science research question.

  • Discuss the advantages of latest regulatory innovations in in clinical drug development

 

Competencies

  • Critical reflect on the value of applied methods
  • Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
  • Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
  • Impact discussions on strategic regulatory decisions

 

The syllabus comprises a selection of book chapters, scientific papers and review papers.

A complete list of reading material will be distributed electronically before the course.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
Lectures, class discussions and group work
Oral
Peer feedback (Students give each other feedback)
Credit
3 ECTS
Type of assessment
Written assignment
The student will be assessed based on a written assignment.
Marking scale
7-point grading scale
Censorship form
No external censorship
Exam period

The exam schedule is available on http://mra.ku.dk/calender/exams/ 

Re-exam

Written response to critique of own report

The exam schedule is available on http://mra.ku.dk/calender/exams/ 

Criteria for exam assesment

To achieve the maximum grade of 12, the student should be able to:

Knowledge

  • Describe the research approaches applied in a Drug Regulatory Science
  • Describe use of strategies and data sources in Drug Regulatory Science research

 

Skills

  • Dicuss choice of research approaches and data sources in Drug Regulatory Science
  • Identify relevant results in Drug Regulatory Science in context of the regulatory systems

 

Competencies

  • Critical reflect on the value of applied methods
  • Reflect on implications of results within Drug Regulatory Science, with the perspective of the society, academia and industry
  • Identify and conceptualise relevant Drug Regulatory Science research question and hypothesis, through analysing the scientific literature in context of regulatory systems
  • Category
  • Hours
  • Preparation
  • 30
  • Lectures
  • 21
  • Project work
  • 18
  • Exam Preparation
  • 14
  • Total
  • 83