SMIMA1081U Drug Regulatory Affairs in Drug Development
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.
Upon completion, participants are expected to be able to:
Knowledge:
- 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
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 syllabus comprises selected EMA guidelines and EC directives, and corresponds to approximately 300 pages required readings.
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Category
- Hours
- Class Instruction
- 38
- Exam
- 2
- Preparation
- 28,75
- Total
- 68,75
Application deadline 1 June 2016
- Credit
- 2,5 ECTS
- Type of assessment
- Written examination, 2 under invigilationThe 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.
- Aid
- 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 http://pc-eksamen.ku.dk/pc_exam 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
To be announced at the MIND programme's webpage.
- Re-exam
To be announced at the MIND programme's webpage
Criteria for exam assesment
Knowledge:
- 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
Skills:
- Explain the scientific advice procedure
- Discuss the law frame and guidelines within regulatory affairs
Competencies:
- Understand, interpret and follow regulatory guidelines
Course information
- Language
- English
- Course code
- SMIMA1081U
- Credit
- 2,5 ECTS
- Level
- Part Time Master
- Duration
- 31 October - 4 November 2016
- Placement
- Autumn
- Schedule
- 5 days
- Course capacity
- 25 participants
- Continuing and further education
- Price
DKK 10,750 (non EU/EEA citizens DKK 12,543. Fee includes course materials and meals. Prices may be subject to change.
- Study board
- Study Board for Part-time Master’s Programmes of Pharmaceutical Sciences
Contracting department
- Department of Pharmacy
Course responsibles
- Per Helboe (10-736875316b686f6572684376787167316e7831676e)