Summary
This three day course 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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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
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Course leader & lecturers
- David HortonCourse leaderDirector
Abbvie USA - Steven JohnsonCourse leaderHead of Global Regulatory Affairs, Acting Head of US Regulatory Affairs
Zealand Pharma A/S - Robert BabilonLecturerPresident
Prosoft Clinical - Jaime DavisLecturerAssociate General Counsel
UCB, USA
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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
- To understand the drug development process in the USA
- Detailed knowledge of US-specific documentation requirements and the procedures and practices of the FDA
- How to reach agreement with the FDA so that development plans provide acceptable study results
- How to analyze and evaluate development plans in terms of the use of best practices required by the FDA
- How to play an important role in any project team working on drug development in the USA
What your company will get
- A regulatory professional who can make recommendations on how to achieve project goals in the shortest possible development time
- A regulatory professional who is able to provide valuable input to all other team members working with drug development plans in the USA.
- An employee who can play an important strategic role in project teams working on obtaining a marketing authorization in the USA
Course calendar
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
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
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
Registration
Registration deadline15 Oct 2025
Lersø Parkallé 101
2100 København Ø
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
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
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
Registration
Registration deadline14 Apr 2027
Lersø Parkallé 101
2100 København Ø
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 held online, usually 4-6 weeks after the course.
You will receive a link with exam questions via your personal Atrium log-in.
In order to participate in the exam, you must have attended the course.
This course is a part of a diploma
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 moreCourse leaders
Abbvie USA
Zealand Pharma A/S
Lecturers
Zealand Pharma A/S
Prosoft Clinical
Abbvie USA
UCB, USA
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3 Dec 2025
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