SMRMIF006U Course in Quality – Active Substance and Medicinal Product
This course is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the course as a single course student.
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 QbD to
global quality trends.
After completion of this course the student should be able to
understand 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 connected to the exam SMRMIF006E Exam in Quality - Active Substance and Medicinal Product. To earn the full 4 ECTS credits, you are required to pass the exam.
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.
- Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval
Skills
- 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 standards
- 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
The syllabus comprises selected CHMP/ICH guidelines and EC directives and regulations. 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.
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
- Category
- Hours
- Lectures
- 22
- Preparation
- 56
- Theory exercises
- 4
- Total
- 82
- Credit
- 3 ECTS
- Type of assessment
- Course participationParticipation in the course is a requirement for participating in the exam SMRMIF003E SMRMIF006E Exam in Quality – Active Substance and Medicinal Product.
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Knowledge
Explain and discuss regulatory quality documentation in regards to medicinal product development
Explain and identify the basic principles of regulatory quality documentation and how this work is regulated through guidelines and standards
Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approvals
Skills
Apply and analyse development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards
Analyse and discuss the CMC documentation in relation to the clinical phases
Competences
Prepare quality plans and describe decision steps with regard to pharmaceutical development and documentation
Course information
- Language
- English
- Course code
- SMRMIF006U
- Credit
- 3 ECTS
- Level
- Part Time Master
- Duration
- Placement
- Autumn
15-17 November 2017
- Schedule
- .
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
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
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Course Coordinators
- Poul Egon Bertelsen
(5-76747a6a7146726b7533766e6778736734697573)
External associate professor - Karen Wibe Enevoldsen (21-6d6374677030796b64673067706778716e667567704275777066306d7730666d)
Poul E. Bertelsen - Associate Principal Scientist, Takeda, Switzerland (chief responsibility)
Karen Wibe Enevoldsen - Head of Section, Pharmaceutical Product Development, LEO Pharma A/S, Denmark