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.
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).
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
Application deadline is 8 weeks before the first day of instrution.
- 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. See dates in the exam schedule 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 (14-78717a713a767b7e73717a7f717a4c7f817a703a77813a7077)
- Jesper Kihl (11-736e7c796e7b3774727175497c7e776d37747e376d74)
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