Module 10 

Summary

This module 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.

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.

Terms and conditions for signing up to and cancelling courses offered in collaboration between Atrium and the University of Copenhagen

• These conditions apply to courses in Regulatory Affairs held in collaboration between Atrium and the University of Copenhagen.
• These conditions apply as long as the campaign offering 2 participants for the price of 1 is valid, i.e. through May 31, 2020.
• Enrolment to the University of Copenhagen via the course application form
• The promotional offer 2 for 1 is obtained when two people from the same company register individually for the course and send an email to master@sund.ku.dk stating who you are participating with.
• If one of the two participants cancels course participation, the full participation fee is still due, since the discount depends on two persons having signed up.
• If one of the two participants cancels course participation, it is not possible for another employee from the company to take that place on the course within the discount scheme.
• It is a condition that the debtor on the two payments is the same.
• Master students' discount of DKK 2,000 waives if the promotional ”2 for 1” offer is used.