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
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
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.
Course leader(s) & Lecturers
- Sandra Auguste-BowlerCourse leaderRegulatory CMC Senior Specialist
Atrium - Heidi Smed ChristensenCourse leaderSenior Director, Regulatory Affairs
Genmab A/S
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
- The basic principles of manufacturing biopharmaceuticals — from the recombinant starting material to the final product
- How to evaluate and organize information provided by CMC/quality stakeholders during product development and post-approval
- 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
- 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
- A regulatory professional who understands the basic principles of manufacturing biopharmaceuticals
- 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
- A regulatory affairs professional who is able to prepare regulatory CMC/Quality strategies considering both FDA and EU aspects
Course calendar
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
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
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
Registration
Registration deadline18. Oct 2021
Venlighedsvej 10
2970 Hørsholm
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
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
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
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
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 moreRegulatory 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 moreCourse leader(s)
Atrium
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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