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Process Development and Production of Active Pharmaceutical Ingredients (API)
Understand the theoretic background and the industrial perspectives on modern drug production and regulations from discovery to routine manufacturing.
This course is a part of
An understanding of chemical development and the particular challenges during each phase is the primary focus of this course.
A combination of theory and practice using fresh examples from industry and the literature will create the foundation for solid decision-making skills and an understanding of the trade terminology.
The development of a safe and efficient manufacturing process of an active pharmaceutical ingredient (API) or bulk drug substance is a substantial undertaking. A successful endeavour requires solving problems within synthetic organic, bioorganic, physical organic, analytical and environmental chemistry, engineering, and economics.
Course content
We have assembled a unique team of industrial speakers who are experts in process development and production of pharmaceutical ingredients. The course will cover both the theoretic background and give an industrial perspective on modern drug production and regulations.
Course directors and lecturers on Process Development and Production of Active Pharmaceutical Ingredients (API)
Course details for Process Development and Production of Active Pharmaceutical Ingredients (API)
Dates and examination
Course dates
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Industrial Drug Development.
Learning outcomes
Upon completion of this course you will:
- Be familiar with the terms, principles and methods used in developing a chemical process from discovery to routine manufacturing.
- Be able to discuss different aspects and solutions to problems in a broad range covering scale-up, organization, planning, process monitoring, validation, life cycle management, registration, resource consumption, environmental and safety issues.
- Be able to closely interact with specialists and work as project leader where process development is a part of the project.
- Have learned how to identify and explain common risks and problems in process development.
- Be able to compute and critically apply various process metrics.
Admission criteria
Professionals in need of interdisciplinary overview
The course is for professionals in the pharmaceutical industry with occasional or regular contact with producers or departments working with process development, or even wish to enter the field yourself. This course gives you a good insight in the processes, regulations and options for the production of both small molecule and biopharmaceutical drugs.
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent
- Have a minimum 2 years of relevant job experience in drug development
- Be proficient in English
Find detailed information in the admission criteria on Master of Industrial Drug Development.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Industrial Drug Development programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
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EU/EEA citizens: 14,450 DKK The fee includes lunch/coffee. |
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66