Quality - Drug Substance and Drug Product – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > Quality - Drug Substan...

Quality - Drug Substance and Drug Product

This course provides the students with a comprehensive overview of the quality related requirements and critical issues of the quality part of a registration dossier of a medicinal product with interfaces to product development and post approval maintenance. The various subjects range from chemical synthesis of active substances and development of medicinal products including QbD to global quality trends.

After completion of this course the student should be able to understand the basic principles of how to design, develop and document active substances and medicinal products i.e. how data are generated and how the work is regulated by guidelines and quality standards. Additionally, the student should be capable of analyzing and evaluating the development processes, reports, specifications, methods and data – all seen from a regulatory point of view.

What do you gain?


  • Explain and discuss regulatory quality requirements and documentation in regards to medicinal product development.
  • Explain and identify the basic principles of regulatory quality requirements and documentation and how this work is regulated through guidelines and standards.
  • Explain and discuss how quality build into daily activities may improve performance and may result in faster submissions and approval


  • Apply and analyse the development processes, reports, specifications, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standards
  • Act in the chemistry, manufacturing and control (CMC) interface
  • Analyse and discuss the CMC documentation in relation to the clinical phases


  • Make quality plans and take decisions with regard to pharmaceutical development

Course dates

  • 8 - 10 October 2018

Application deadline:

  • 10 September 2018

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application.
Please note that the course
can be cancel or rescheduled if the number of participants fails to meet the required minimum.

Exam dates

  •  7 November 2018

Course fee

EU/EEA citizens Non EU/EEA citizens
Master student DKK 17.975 DKK 19.975
Single course student DKK 19.975 DKK 22.000