External Lecturer, Department of Pharmacy, University of Copenhagen and Director, Head of RA-CMC, H. LUNDBECK A/S
Quality - Drug Substance and Drug Product
Learn the basic principles of how to design, develop and document active substances and medicinal products and how the work is regulated by guidelines and quality standards.
This course provides you 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 Quality by Design (QbD) to global quality trends.
Course content
Attendees will get an understanding of 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.
Course Directors on Quality - Drug Substance and Drug Product
Karen Fich
Inger Mollerup
External Lecturer, Department of Pharmacy, University of Copenhagen and Independent Regulatory Consultant, Inger Mollerup Regulatory Consulting
Course details about Quality - Drug Substance and Drug Product
Dates and examination
Course dates
25 - 27 February 2026
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 Medicines Regulatory Affairs.
Learning outcomes
This course will introduce you to regulatory quality requirements and documentation in regards to medicinal product development. You will be able to explain and identify the basic principles of regulatory quality requirements and documentation and learn how this work is regulated through guidelines and standards in order to obtain a market authorisation.
You will learn to apply and analyse the development processes, methods and data to ensure coherency and transparency of the quality dossier and compliance with required guidelines and quality standard. The course will teach you how to act in the chemistry, manufacturing and control (CMC) interface, and analyse and discuss the CMC documentation in relation to the clinical phases.
After the course, you will be able to make quality plans and take decisions with regard to pharmaceutical development. Lastly, you will learn to review and assess pharmaceutical data and documentation at all levels of the drug development and life cycle.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
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
- Be proficient in English
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
You will receive a response to your application at the earliest on 1 May and no later than 2 weeks after the application deadline.
Priority is given to enrolled students
This course is offered as a fixed elective course in the Master of Medicines Regulatory Affairs 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.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
2026 prices
EU/EEA citizens
Master student: 21,401 DKK
Single course: 23,401 DKK
Non-EU/EEA citizens
Master student: 23,801 DKK
Single course: 25,801 DKK
The fee includes lunch/coffee.
Place
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66