Drug Regulatory Affairs in Drug Development

Course 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.

Education

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

 

See course calendar for course dates on the webpage for  Master of 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).

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 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.

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

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 development of medicines
• Proficiency in English

Oral
Collective
ECTS
2,5 ECTS
Type of assessment
On-site written exam, 2 hours
Type of assessment details
The test is composed of essay questions in Digital Exam platform (DE). 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

To be announced at the MIND programme's webpage.

Re-exam

The exam form for the reexam is the same as the ordinary exam. Se dates in the examplan at the MIND programme's webpage

Criteria for exam assessment

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

Part time Master and Diploma courses

  • Category
  • Hours
  • Class Instruction
  • 38
  • Preparation
  • 28,75
  • Exam
  • 2
  • English
  • 68,75

Kursusinformation

Language
English
Course number
SMIMA1081U
ECTS
2,5 ECTS
Programme level
Part Time Master
Duration
5 days
Placement
Autumn
Price

Fees are published on the programme's homepage at  https://mind.ku.dk/tuition/

Fee includes course materials and lunch/coffee. 

Prices may be subject to change.

Schedulegroup
See course calendar
Capacity
25 participants
Studyboard
Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
  • Department of Pharmacy
Contracting faculty
  • Faculty of Health and Medical Sciences
Course Coordinators
  • Lene Jørgensen   (14-7770797039757a7d7270797e70794b7e80796f397680396f76)
  • Jesper Kihl   (11-726d7b786d7a3673717074487b7d766c36737d366c73)
Saved on the 04-04-2024

Are you BA- or KA-student?

Are you bachelor- or kandidat-student, then find the course in the course catalog for students:

Courseinformation of students