Biopharmaceuticals - Quality Development and Documentation, module 10

Get an understanding of the quality issues specific to biopharmaceuticals

5 - 7 Dec 2023

On location

English

21,730 DKK ex VAT

(app. 2,922 EUR ex VAT)

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.


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


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

    Hi! 

    Do you need help choosing the right course? 

    We are ready to help you at +45 39 27 60 60 or contact@atriumcph.com 

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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.


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Course leader(s) & Lecturer(s)

  • Sandra Auguste-Bowler
    Course leader
    Principal regulatory specialist
    Novo Nordisk A/S
  • Heidi Smed Christensen
    Course leader
    Senior Director, Regulatory Affairs
    Genmab A/S
  • Allan Hey
    Lecturer
    CMC Consultant, Manangara Ltd
    Atrium
  • Anne Kroll Kristensen
    Lecturer
    Principal Scientist
    Novo Nordisk A/S
  • Lisbeth Palm
    Lecturer
    Senior Project Manager
    Novo Nordisk A/S
  • Florian Lengyel
    Lecturer
    Global CMC Expert NBE/Biosimilars
    Boehringer Ingelheim Pharma GmbH & Co. KG
  • Anna Karin Rehnström
    Lecturer
    Head of the Biotechnology group at the Swedish Medical Products Agency
    Swedish Medicines Products Agency - MPA
  • Steffen Gross
    Lecturer
    Head of Section Quality and Non-Clinical Evaluation of Antibody Therapeutics
    Paul-Ehrlich-Institut (PEI)
  • Sarah Gilgunn
    Lecturer
    Ph.d., Pharmaceutical Assessor (Biologicals), Human Authorisation and Registration
    Health Products Regulatory Authority
  • Margrethe Erbou Andersen
    Lecturer
    VP Regulatory Affairs
    Galecto Biotech AB
  • Asser Sloth Andersen
    Lecturer
    Senior Principal Scientist
    Novo Nordisk A/S
See all

IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills

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

Course calendar

Starting 5 Dec 2023
5 Dec 2023 8:00-19:00

DAY 1

  • Why the regulatory agencies treat biopharmaceuticals differently than chemical pharmaceuticals
  • CMC/Quality sections for IND/CTA and BLA/NDA/MAA in CTD format including electronic submission to FDA as eCTD
  • Generation of the recombinant construct, cell banks and expression
  • Stability studies for drug substance and drug product
  • Purification and process validation
  • Group work
6 Dec 2023 8:00-18:00

DAY 2

  • Formulation development and drug product manufacturing
  • Demonstrating product comparability during development and post-approval
  • Biosimilars
  • Regulatory expectations for product characterization
  • Setting a product specification for drug substance and drug product
  • Group work
7 Dec 2023 8:00-16:30

DAY 3

  • Key elements necessary for a complete quality regulatory compliance strategy
  • FDA regulatory procedures for biotech products
  • EU regulatory procedures for biotech products
  • Regulatory CMC strategies in the EU during development
  • Group work
Practical information

Registration

Registration deadline
7 Nov 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
5 - 7 Dec
Sometimes things change. This is the expected programme.

Course information

Literature

Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus. 

Prerequisites

To enroll in this course, you must have a relevant educational background at bachelor level and, as a minimum, two years of experience in regulatory affairs, or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 20% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs. We consider applicants on a case-by-case basis.

Examination

The exam is usually held 4-6 weeks after the course.

It is a digital exam in the University of Copenhagen’s digital exam system.

This course is a part of this programme

Diploma in Regulatory Affairs

This diploma in regulatory affairs gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

Read more
Master of Medicines Regulatory Affairs (MRA)

Are you a regulatory affairs professional and are you concerned with your ongoing learning and development consider these courses, offered in development with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA)

Read more

Course leader(s)

Sandra Auguste-Bowler
Principal regulatory specialist
Novo Nordisk A/S
Heidi Smed Christensen
Senior Director, Regulatory Affairs
Genmab A/S

Lecturer(s)

Sandra Auguste-Bowler
Principal regulatory specialist
Novo Nordisk A/S
Allan Hey
CMC Consultant, Manangara Ltd
Atrium
Anne Kroll Kristensen
Principal Scientist
Novo Nordisk A/S
Lisbeth Palm
Senior Project Manager
Novo Nordisk A/S
Florian Lengyel
Global CMC Expert NBE/Biosimilars
Boehringer Ingelheim Pharma GmbH & Co. KG
Anna Karin Rehnström
Head of the Biotechnology group at the Swedish Medical Products Agency
Swedish Medicines Products Agency - MPA
Steffen Gross
Head of Section Quality and Non-Clinical Evaluation of Antibody Therapeutics
Paul-Ehrlich-Institut (PEI)
Sarah Gilgunn
Ph.d., Pharmaceutical Assessor (Biologicals), Human Authorisation and Registration
Health Products Regulatory Authority
Margrethe Erbou Andersen
VP Regulatory Affairs
Galecto Biotech AB
Asser Sloth Andersen
Senior Principal Scientist
Novo Nordisk A/S
Heidi Smed Christensen
Senior Director, Regulatory Affairs
Genmab A/S

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WANT TO KNOW MORE or need help?

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

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