Course An introduction to Good Manufacturing Practice (GMP)

An introduction to Good Manufacturing Practice (GMP)

Reg. no. C254/05

is being offered by the Graduate School of Health, Aarhus University, fall 2020.

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 outcome: At the end of the course the PhD student should:

• 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

Contents: 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

Recommended knowledge for participation: The course addresses participants without or only very limited knowledge of GMP.

Language: English

ECTS: 2,1

Head of Course: Dirk Bender and Anja P. Einholm

Number of Participants: 24

Dates and Times: 17 and 24 September, 1 October 2020, at approx. 8.30-16.00

Place: Kollokvierum Øst (1268-218), Victor Albeck Bygningen, Vennelyst Blvd 4, 8000 Aarhus C

Course Fee: DKK 2520

Participation in the course is without cost for:

• PhD students, Research Year students and 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

Application deadline: 20 August 2020

Application: https://service.health.au.dk/modules/Course/mypage/coursecalendar.

Course dates:

• 17 September 2020