Biopharmaceuticals - Quality Development and Documentation

Get an understanding of the quality issues specific to biopharmaceuticals

15. Nov 2021
30. Nov 2022

3 days course

English

20,700 DKK ex VAT
(app. 2,783 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.

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.

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    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

    Choose your starting date
    Starting 15. Nov 2021
    Starting 30. Nov 2022
    15. Nov 2021 9:00-16:00

    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
    16. Nov 2021 9:00-16:00

    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
    17. Nov 2021 9:00-16:00

    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
    18. Oct 2021
    Søhuset Konferencecenter
    Venlighedsvej 10
    2970 Hørsholm
    Register
    30. Nov 2022 9:00-16:00

    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
    1. Dec 2022 9:00-16:00

    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
    2. Dec 2022 9:00-16:00

    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
    2. Nov 2022
    Atrium
    Lersø Parkallé 101
    2100 København Ø
    Register
    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. You can therefore take the exam in your own country.

    Please let us know if this is relevant for you as we can conduct exams at embassies, universities and so on worldwide.

    This course is a part of this programme

    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)

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    Regulatory Affairs Diploma

    The regulatory affairs diploma 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

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    WANT TO KNOW MORE or need help?

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

    Send me a message