Quality – Drug Substance and Drug Product
Course content
This course provides the students with a comprehensive overview
of the quality related requirements and critical issues of the
quality part of a registration dossier of a medicinal product with
interfaces to product development and post approval maintenance.
The various subjects range from chemical synthesis of active
substances and development of medicinal products including Quality
bu Design (QbD) to global quality trends.
Attendees wil get an understanding of the basic principles of how
to design, develop and document active substances and medicinal
products i.e. how data are generated and how the work is regulated
by guidelines and quality standards. Additionally, the student
should be capable of analyzing and evaluating the development
processes, reports, specifications, methods and data – all seen
from a regulatory point of view.
This course is offered in collaboration between University of Copenhagen and Atrium as part of the Master of Medicines Regulatory Affairs.
See course calendar for course dates on the webpage for Master of Medicines Regulatory Affairs
This course is one of the fixed electives at both the 2016-curriculum and the 2018-curriculum.
The course is also open for single course student.
Knowledge
-
Explain and discuss regulatory quality requirements and documentation in regards to medicinal product development.
-
Explain and identify the basic principles of regulatory quality requirements and documentation and how this work is regulated through guidelines and standards.
Skills
- Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval
- Apply and analyse the development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standard
- Act in the chemistry, manufacturing and control (CMC) interface
- Analyse and discuss the CMC documentation in relation to the clinical phases
Competencies
-
Make quality plans and take decisions with regard to pharmaceutical development
-
make descisions with regard to pharmaceutical development and documentation necessary for optaining a market authorisation
-
review and asses pharmaceutical data and documentation at all levels of the drug development and life cycle reflection a quality mindset
Lectures, workshops and self-study of course literature
The syllabus comprises selected EU, USA and ICH legislation and guidelines. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to study parts of the syllabus, corresponding to approximately 800 pages.
Applicants must meet the following criteria:
• A bachelor's degree or a master’s degree in health and
medical sciences, natural sciences, applied sciences or equivalent
• At least 2 years work experience in the pharmaceutical industry,
in a medicines agency or in another relevant organization or
company
• Proficiency in English
Application deadline is 4 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- ECTS
- 4 ECTS
- Type of assessment
-
Written assignment, 3 hours
- Type of assessment details
- 3 hours written assignment with descriptive questions and multiple choice held on Digital Exam - The online platform for examination at the University of Copenhagen.
- Aid
- All aids allowed
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
- Exam period
-
Exam schedule is published on mra.ku.dk
- Re-exam
-
Exam schedule is published on mra.ku.dk
Criteria for exam assessment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
-
Explain and discuss regulatory quality requirements and documentation in regards to medicinal product development.
-
Explain and identify the basic principles of regulatory quality requirements and documentation and how this work is regulated through guidelines and standards.
Skills
- Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval
- Apply and analyse the development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standard
- Analyse and discuss the CMC documentation in relation to the clinical phases
Competencies
-
Make quality plans and take decisions with regard to pharmaceutical development
Part time Master and Diploma courses
- Category
- Hours
- Lectures
- 22
- Preparation
- 61
- Theory exercises
- 4
- Exam Preparation
- 20
- Exam
- 3
- English
- 110
Kursusinformation
- Language
- English
- Course number
- SMRM18010U
- ECTS
- 4 ECTS
- Programme level
- Part Time Master
- Duration
-
3 days
- Placement
- Spring And Autumn
- Price
-
Prices vary according to type of enrolment and nationality. For details please visit: MRA programme webpage
Fee includes course materials and meals during the days and a networking dinner the first evening. If textbooks are required, it must be purchased by the participants
- Schedulegroup
-
3 days full time
- Capacity
- 30
- 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
- Karen Brorson Fich (10-776d7e717a3a72756f744c7f817a703a77813a7077)
- Inger Mollerup (14-6e736c6a7733727471716a777a7545787a736933707a336970)
Karen Fich, Director, Head of RA, CMC, H. Lundbeck, Denmark
Inger Mollerup, Inger Mollerup Regulatory Consulting
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