Course An introduction to Good Manufacturing Practice (GMP)

The course J.nr C254 An introduction to Good Manufacturing Practice (GMP) is being offered by the Graduate School of Health, Aarhus University, 2025.

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).

Requirements for participation:

Aim: To introduce PhD students at Health, Aarhus University to the basic terms and principles of GMP controlled manufacture of pharmaceutical products

Learning outcomes: 

• 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 39.25 hours

Content: 

• GxP, GMP, EU GMP, US GMP, WHO GMP, PIC/S What is this?
• History of GMP

• Introduction to most relevant EU-GMP guidelines
• GMP Interpretation in Industry, Public Service Institutions, and at Authorities.

• GMP case study

Instructors: 

• Dirk Bender, assosicate professor, AU, and chief-chemist, AUH NUK PET.
• Knud Ryhl, QMA specialist and H&S representative, Fuji Film.
• Thomas Noe Vestergaard Pedersen, teamleader and auditor, Danish Medicines Agency.
• Karina Hørup Vase, QA manager, AUH NUK PET.
• Karina Cullberg, regulatory manager,DSM- Firmenich

Venue: Aarhus University, Aarhus.

Participation in the course is without cost for:

• PhD students, Health Research Year 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

Course dates:

• 11 September 2025 08:30 - 16:00
• 18 September 2025 08:30 - 16:00
• 25 September 2025 08:30 - 16:00