Course leader: Dirk Bender
Graduate school: Faculty of Health
Graduate program: ClinFO
Course fee: 1,440.00 DKK
Status: Course is open for application
Semester: Fall 2022
Application deadline: 01/09/2022
Start date: 29/09/2022
Administrator: Annette Poulsen
The course, C254/07 An introduction to Good Manufacturing Practice (GMP), is being offered by the Graduate School of Health, Aarhus University, fall 2022.
Criteria for participation: University degree in medicine, dentistry, nursing, or Master’s degree in other fields and/or postgraduate research fellows (PhD students and research-year medical students).
Recommended knowledge for participation: The course addresses participants without or only very limited knowledge of GMP.
Aim: To introduce PhD students at Health, Aarhus University to the basic terms and principles of GMP controlled manufacture of pharmaceutical products
- Be familiar with basic principles and terms of GMP and its impact in Danish legislation
- Be able to understand specific challenges arising from GMP
- Know where to seek advice concerning further development of GMP skills
Workload: The full workload of the course is expected to be 30,25 hours.
Content: Introduction to the historic development of GMP
- GxP, GMP, EU GMP, US GMP, WHO GMP, PIC/S What is this?
- Introduction to most relevant EU-GMP guidelines
- GMP Interpretation in Industry, Public Service Institutions, and at Authorities
- GMP case study
Instructors: Dirk Bender and external instructors
Venue: The Victor Albeck Bygningen (1268), Vennelyst Blvd 4, 8000 Aarhus C
Participation in the course is without cost for:
- PhD students, Health Research Year students and Health Research Honours Programme students from Aarhus University
- PhD students enrolled at partner universities of the Nordoc collaboration
- PhD students from other institutions in the open market agreement for PhD courses
- 29 September 2022 08:30 - 16:00
- 06 October 2022 08:30 - 16:00
- 27 October 2022 08:30 - 16:00