Quality - Drug Substance and Drug Product

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.

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.

Innovate and strengthen the regulatory process  

The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.

Participants must

• Hold a relevant bachelor degree or equivalent
• Have a minimum 2 years of relevant job experience
• Be proficient in English

Find detailed information about the admission criteria.

This course is offered as a fixed elective course on the Master of Medicines Regulatory Affairs programme.

Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.

You must choose minimum one of the fixed elective courses to complete the Master of Medicines Regulatory Affairs programme. 

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.