The Regulatory Affair Environment in the USA

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

  • TBD

3 days course

English

17.350,- DKK ex VAT
(app. 2.333,- EUR ex VAT)

At the moment there is no available dates for this course.

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.


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

  

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.

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

Registration quick facts for master modules

When you click the “register”-button you will get to the joint Atrium and University of Copenhagen application form. To apply for the course you must fill out the form and send in the relevant documentation. If your application is accepted you will be enrolled both at Atrium and at the University of Copenhagen and your data will be registered at both institutions.

All modules that are mandatory in the Master of Medicines Regulatory Affairs at the University of Copenhagen are paid by invoice sent from the University of Copenhagen. See the University of Copenhagen’s terms and conditions here.

All the master modules can be taken individually. If you are not enrolled as a master student, you will be registered as a single course student at the University of Copenhagen.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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