Biopharmaceuticals - Quality Development and Documentation

Get an understanding of the quality issues specific to biopharmaceuticals

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  • 5. Oct 2020

3 days course

English

17.650,- DKK ex VAT
(app. 2.373,- EUR ex VAT)

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Course fee is DKK 17,650 + exam fee DKK 2,625 = DKK 20,275 in total. For refund of exam fee, see "Please note" below. 

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 is DKK 17,650 + exam fee DKK 2,625 = DKK 20,275 in total. 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.

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
Available start dates
5. Oct 2020 (Registration deadline 7. Sep 2020)
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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.

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This course is a part of this programme

Master of Medicines Regulatory Affairs (MRA)

University of Copenhagen in collaboration with Atrium ... Read more

In cooperation with

Regulatory Affairs Diploma

Theoretical and practical aspects ... Read more

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send an email

 

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