The US Regulatory Environment, module 3

Understand how to best develop and gain approval for a new drug or biologic in the USA

16 - 18 Apr 2024

On location


22,273 DKK ex VAT

(app. 2,995 EUR ex VAT)


Module 3

This module will provide you with a general understanding of how to best develop and gain approval for a new drug or biologic in the USA with emphasis on the requirements for development and maintenance of new drugs.

During drug development, sponsors must interact with the Food and Drug Administration (FDA) on a regular basis in order to agree on the best programme of studies, which will thereby provide the required data. Sponsors must also demonstrate that the drug meets the quality standards required for approval. There are various programmes available that can be used to speed up drug development and regulatory approval if requested by sponsors and agreed to by the agency.

We will focus on how you should interact with the various centers at the FDA, including the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), from early non-clinical and clinical research to post-approval obligations. We will also compare and contrast these to the EU and ICH guidelines and requirements.

Other course participants say

"I think the course managed to cover a vast amount of information, and I can actively use it all in my day-to-day work."

Katrine Schultz-Knudsen, Graduate, Regulatory Dossier Management, H. Lundbeck A/S

"Very competent, skilled and knowledgeable presenters who also master the art of presenting information in a structured and joyful way. I felt I was given a very good introduction to all areas involved in the US regulatory area."

Michala Victor, Senior CMC Writer, Genmab

It was a pleasure participate on this course. The presenters were very skilled and experienced in the RA area, and their enthusiasm and drive for their area was very inspirational.
Furthermore, I really appreciated the many examples form real life projects. It made it much more interesting. The course leaders and presenters were open and encouraged participants to ask questions and be actively involved.

Catalin Frydendal, Specialist, Regulatory Affairs, Fertin Pharma A/S


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    • Regulatory Affairs in the USA
    • The Food and Drug Administration (FDA)
    • Fast track development
    • Accelerated approvals
    • Orphan drugs
    • Labeling and advertising regulation
    • Life cycle management
    • Regional differences between the European Medicines Agency (EMA) and the FDA

    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 & lecturers

    • David Horton
      Course leader
      Abbvie USA
    • Robert Babilon
      Course leader
      Prosoft Clinical
    • John Geigert
      BioPharmaceutical Quality Solutions
    • Dale Cooke
      PhillyCooke Consulting
    • Lars Hyveled-Nielsen
      Regulatory Project Director
    • Drew Barlow
      SVP, Head of CMC Regulatory Affairs
      Syner-G BioPharma
    • Steven Johnson
      Head of Global Regulatory Affairs
    See all

    Is this course for you?

    This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.

    You must have a minimum of 2 years relevant job experience. 

    What you will learn

    1. To understand the drug development process in the USA
    2. Detailed knowledge of US-specific documentation requirements and the procedures and practices of the FDA
    3. How to reach agreement with the FDA so that development plans provide acceptable study results
    4. How to analyze and evaluate development plans in terms of the use of best practices required by the FDA
    5. How to play an important role in any project team working on drug development in the USA

    What your company will get

    1. A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
    2. A regulatory professional who is able to provide valuable input to all other team members working with drug development plans in the USA.
    3. An employee who can play an important strategic role in project teams working on obtaining a marketing authorization in the USA

    Course calendar

    Starting 16 Apr 2024
    16 Apr 2024 9:00-16:00

    Day 1

    • Light breakfast and networking
    • Welcome
    • FDA organization and overview of the US FDA Regulatory Submissions
    • FDA.Gov web demo
    • CMC requitements - NCSs/Small molecules
    • CMC requirements – biologicals and the FDA
    • CMC requirements – FDA biological CMC regulation
    17 Apr 2024 9:00-16:00

    Day 2

    • Light breakfast and networking
    • Short summary of day 1 and introduction to day 2
    • Nonclinical requirements
    • Clinical requirements
    • Communication with the FDA during development
    • Leveraging FDA regulatory tools and new pilot programs to expedite development
    • NDA/BLA – content, format and review process
    • Labelling and advertising regulation
    • Life cycle management: NDA/BLA
    • Recap of the day and questions
    18 Apr 2024 9:00-16:00

    Day 3

    • Light breakfast and networking
    • Introduction to day 3
    • ANDAs
    • Current topics in US Regulatory Affairs
    • Regional differences between EMA and the FDA
    • Groupwork
    • End of module 3
    Practical information


    Registration deadline
    5 Mar 2024
    Lersø Parkallé 101
    2100 København Ø
    16 - 18 Apr
    Sometimes things change. This is the expected programme.

    Course information


    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.


    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 10% 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.


    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 a diploma

    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 together with University of Copenhagen. Explore the Master of Medicines Regulatory Affairs (MRA).

    Read more
    Diploma in Regulatory Affairs

    The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

    Read more

    Course leaders

    David Horton
    Abbvie USA
    Robert Babilon
    Prosoft Clinical


    Robert Babilon
    Prosoft Clinical
    John Geigert
    BioPharmaceutical Quality Solutions
    Dale Cooke
    PhillyCooke Consulting
    Lars Hyveled-Nielsen
    Regulatory Project Director
    David Horton
    Abbvie USA
    Drew Barlow
    SVP, Head of CMC Regulatory Affairs
    Syner-G BioPharma
    Steven Johnson
    Head of Global Regulatory Affairs

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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