Biopharmaceuticals - Quality Development and Documentation

Get an understanding of the quality issues specific to biopharmaceuticals

  • TBD

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

At the moment there is no available dates for this course.

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.

What you will learn

  1. The basic principles of manufacturing biopharmaceuticals — from the recombinant starting material to the final product
  2. How to evaluate and organize information provided by CMC/quality stakeholders during product development and post-approval
  3. How to prepare regulatory CMC/quality strategies considering both FDA and EU aspects throughout clinical development and how to evaluate relevant regulations and guidelines for biopharmaceuticals
  4. How to use best practice in product characterization and how to set the release and stability specifications of a biopharmaceutical

What your company will get

  1. A regulatory professional who understands the basic principles of manufacturing biopharmaceuticals
  2. A regulatory affairs professional who is able to evaluate and organize the information and documentation provided by CMC/Quality stakeholders, challenge it and ask the right questions
  3. A regulatory affairs professional who is able to prepare regulatory CMC/Quality strategies considering both FDA and EU aspects

Registration quick facts for master modules

When you click the “register”-button you will get to the joint Atrium and University of Copenhagen application form. To apply for the course you must fill out the form and send in the relevant documentation. If your application is accepted you will be enrolled both at Atrium and at the University of Copenhagen and your data will be registered at both institutions.

All modules that are mandatory in the Master of Medicines Regulatory Affairs at the University of Copenhagen are paid by invoice sent from the University of Copenhagen. See the University of Copenhagen’s terms and conditions here.

All the master modules can be taken individually. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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