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.
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.
- 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.
- 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
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.
|Dates:||10-12 October 2023|
|Frequency:||Once per year|
|Course fee:||EU/EEA citizens
Master student: 19,730 DKK
Single course participants: 21,730 DKK
The fee includes lunch/coffee.
|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