Course An introduction to Good Manufacturing Practice (GMP)

The course C254/09 An introduction to Good Manufacturing Practice (GMP) is being offered by the Graduate School of Health, Aarhus University, 2024.

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).

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?
• 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, Novo Nordisk.
• Thomas Noe Vestergaard Pedersen, teamleader and auditor, Danish Medicines Agency.
• Karina Hørup Vase, QA manager, AUH NUK PET.
• Karina Cullberg, regulatory manager, 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:

• 12 September 2024 08:30 - 16:00
• 19 September 2024 08:30 - 16:00
• 26 September 2024 08:30 - 16:00