Summary
This three day course will provide you with a comprehensive overview of the quality-related requirements and critical issues of the quality part of the dossier with interfaces to product development and post-approval maintenance. You will learn about various subjects ranging from chemical synthesis of active substances and development of drug products to global quality trends. You will get an understanding of the CTD Module 3 and Quality Overall Summary Module 2, critical issues during development and in the submission stage, and how to compile the dossier with a view to future product maintenance.
You will receive lectures from international lecturers with extensive experience and expertise within chemical, pharmaceutical and analytical Development.
The course is offered every year.
Other course participants say
"It's an excellent course for someone needing an overview of 32S and 32P with deep dives into some of the topics. The workshops were the best thing about the course because they gave rise to good discussions."
Jeff Møller, Regulatory Affairs Specialist, Pharmacosmos
"The course is very comprehensive and helpful for colleagues who want to start a career in CMC."
Antonina Barna, Commercial Supply Manager, Vertex Pharmaceuticals, UK
"The topics were overall relevant and the programme had a good flow. The lecturers were also skilled and interesting to listen to."
Celina, RA CMC Specialist
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Keywords
- Development of Drug Substance and Drug Product
- The ICH Vision
- CMC Documentation
- Container Closure Systems
- Control of Drug Substance and Drug Product
- Pharmacopoeia
- Impurities
- Certificate of the European Pharmacopoeia (CEP)
- The Quality Overall Summary
- Global Quality Dossier
Please note
As this module is a mandatory module in the Master of Medicines Regulatory Affairs at the University of Copenhagen, you will apply via the joint Atrium and University of Copenhagen application form. This means that you will be enrolled at both Atrium and the University of Copenhagen, and that your data will be registered at both institutions. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.
Course fee includes examination. By default you will pay the full amount to the University of Copenhagen regardless of you taking the exam or not. If you decide not to take the exam, you can apply for a refund of the exam fee at Atrium by contacting Atrium - please see contact details below. You must apply for a refund no later than two weeks after completion of the course.
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Course leader & lecturers
- Inger MollerupCourse leaderIndependent Regulatory Consultant
Inger Mollerup Regulatory Consulting - Karen FichCourse leaderRA-CMC Lead Specialist
H. LUNDBECK A/S - Suzanne WigchertLecturerAssociate Director Regulatory Strategy Benelux
Vertex Pharmaceuticals - Siv Holm AndersenLecturerSenior Regulatory Professional, Product Lead
Novo Nordisk A/S - Siham BarghadouchLecturerProject Manager, Primary Packaging R&D, Devices & Delivery Solutions
Novo Nordisk A/S - Rikke PedersenLecturerSenior Regulatory Affair Professional
Novo Nordisk A/S - Peter HudsonLecturerPhd, Senior Director, Head of PMO
Hovione - Michala de NeergaardLecturerLate Stage Analytical Development, Manager
ALK-ABELLÓ NORDIC A/S - Christine WeberLecturerPrincipal Scientific Consultant
Emendo a/s - Patrizia CaliLecturer
Ascendis Pharma A/S
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Is this course for you?
This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.
You must have a minimum of 2 years relevant job experience.
What you will learn
- To understand the basic principles of how to design, develop and document drug substances and drug products
- How data is generated, and how the work with drug substances and drug products is regulated by guidelines and standards
- How to analyze and evaluate development processes, reports, specifications, methods and data from a regulatory point of view in order to ensure coherency and transparency of the quality dossier and other regulatory documentation
What your company will get
- A regulatory affairs professional who understands the principles of the quality part of the dossier
- A regulatory affairs professional who is able to analyze and evaluate the development processes, reports, specifications, methods and data from a regulatory point of view
- A regulatory affairs professional who is able to challenge and ask the right questions with respect to the quality-related documentation
Course calendar
Day 1
- Light breakfast and network
- Introduction, overall process, and expectations
- Development of drug substance and drug product in the overall development programme
- The ICH vision – Q8, Q9, Q10, Q11 and Q12
- Workshop
- Drug substance synthesis
- Drug substance characterization
- Preformulation
- Kahoot
- Workshop
- Networking with tapas
Day 2
- Light breakfast and network
- Short summary of day 1 and introduction to day 2
- Drug product
- Impurities
- Control of drug substance and drug product and developing specifications: Drug substance and drug product
- Workshop
Day 3
- Light breakfast and network
- Short summary of day 2 and introduction to day 3
- Container closure systems
- Stability, drug substance and drug product
- The quality overall summary
- Accelerated development & workshop
- Life cycle management
- Rounding off
- End of course
Registration
Registration deadline14 Jan 2026
Lersø Parkallé 101
2100 København Ø
Course information
Literature
Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.
Please familiarize yourself with the mandatory readings before starting the course.
The mandatory readings are also part of the examination syllabus.
Prerequisites
To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.
If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.
Examination
The exam is usually held 4-6 weeks after the course.
It is a digital exam in the University of Copenhagen’s digital exam system.
This course is a part of a diploma
The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.
Read moreCourse leaders
Inger Mollerup Regulatory Consulting
H. LUNDBECK A/S
Lecturers
Vertex Pharmaceuticals
Novo Nordisk A/S
Novo Nordisk A/S
Novo Nordisk A/S
Hovione
ALK-ABELLÓ NORDIC A/S
Emendo a/s
Ascendis Pharma A/S
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Want to know more or need help?
Contact Educational Programme Leader Lone Rex at +45 20 62 11 46
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