10 October 2023

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. 

Quality - Drug Substance and Drug Product

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. 












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.




















    • Lene Jørgensen, Associate Professor and Head of Studies, Department of Pharmacy, University of Copenhagen, Denmark

    Karen Fich, Director, Head of RA, CMC, H. Lundbeck, Denmark 

    Inge Møllerup, Inger Mollerup Regulatory Consulting























Course details

Duration: 3 days 
Dates: 10-12 October 2023 
Frequency: Once per year
Place: Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 19,730 DKK
Single course participants: 21,730 DKK

Non-EU/EEA citizens
Master student: 21,730 DKK
Single course participants: 23,730 DKK

The fee includes lunch/coffee.

Payment conditions

Level and credit: Master course; 4 ECTS
Examination date: See exam schedule
Application deadline: 29 August 2023
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs

Course dates and application deadlines are announced via the programme newsletter.

Download course curriculum