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.

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.

Terms and conditions for signing up to and cancelling courses offered in collaboration between Atrium and the University of Copenhagen

• These conditions apply to courses in Regulatory Affairs held in collaboration between Atrium and the University of Copenhagen.
• These conditions apply as long as the campaign offering 2 participants for the price of 1 is valid, i.e. through May 31, 2020.
• Enrolment to the University of Copenhagen via the course application form
• The promotional offer 2 for 1 is obtained when two people from the same company register individually for the course and send an email to master@sund.ku.dk stating who you are participating with.
• If one of the two participants cancels course participation, the full participation fee is still due, since the discount depends on two persons having signed up.
• If one of the two participants cancels course participation, it is not possible for another employee from the company to take that place on the course within the discount scheme.
• It is a condition that the debtor on the two payments is the same.
• Master students' discount of DKK 2,000 waives if the promotional ”2 for 1” offer is used.