Quality - Drug Substance and Drug Product

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

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.