Biopharmaceuticals - Quality Development and Documentation

Summary

This three day course will teach you about the scientific background of biologics and biotechnological products as well as which regulatory requirements you need to fulfil in order to obtain approval for these types of medicinal products. 

You will get an understanding of the quality issues specific to biopharmaceuticals. As process changes are inevitable during the development of a biological/biotechnological product, this course will teach you about the implications of changes in the production process and elaborate on the concept of comparability. 

You will also learn how to prepare regulatory (CMC)  and quality strategies as well as how to ensure that you are compliant with regulatory requirements throughout the clinical development and post-approval processes. Our discussions on CMC/Quality strategies will include both FDA and EU aspects as well as FDA and EU regulatory procedures for approval.

Other course participants say

"The course has provided me with a very good overview and understanding on the regulatory CMC requirements for development of biologics." 

Helene Mortensen, Principal Scientist, Biopharmaceutical Product Development, CMC, LEO Pharma A/S

“Good introductory course to regulatory processes.“ 

Birgitte Schousboe, QA Manager, Symphogen A/S

Keywords

• Biopharmaceuticals
• Chemistry, Manufacturing and Controls (CMC)
• Regulatory CMC strategies
• Quality Sections for IND/CTA and BLA/NDA /MAA
• Product Comparability
• Biosimilars
• Product Characterization and Specification
• Quality Regulatory Compliance Strategy
• EU and FDA Regulatory Procedures for Biotech Products

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.