The US Regulatory Environment, module 3

Understand how to best develop and gain approval for a new drug or biologic in the USA
7 Jun 2023

3 days course

English

21,730 DKK ex VAT
(app. 2,922 EUR ex VAT)

Module 3

Summary

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

KEYWORDS

  • 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

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)

  • David Horton
    Course leader
    Director
    Abbvie USA
  • Robert Babilon
    Course leader
    President
    Prosoft Clinical
  • John Geigert
    Lecturer
    President
    BioPharmaceutical Quality Solutions
  • Dale Cooke
    Lecturer
    President
    PhillyCooke Consulting
  • Lars Hyveled-Nielsen
    Lecturer
    Regulatory Project Director
    ZEALAND PHARMA A/S
  • Drew Barlow
    Lecturer
    SVP, Head of CMC Regulatory Affairs
    Syner-G BioPharma
  • Steven Johnson
    Lecturer
    Head of Global Regulatory Affairs, Acting Head of US Regulatory Affairs
    UCB
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. 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 7 Jun 2023
7 Jun 2023 8:15-16:15

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
8 Jun 2023 8:00-17:35

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
9 Jun 2023 8:00-16:50

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

Registration deadline
10 May 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
7 - 9 Jun
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 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.

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

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
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

Course leader(s)

David Horton
Director
Abbvie USA
Robert Babilon
President
Prosoft Clinical

Lecturer(s)

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

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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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