The US Regulatory Environment – University of Copenhagen

Master of Medicines Regulatory Affairs > Courses > The US Regulatory Envi...

The US Regulatory Environment

The course provides an in-depth overview of the US FDA organization, history, legal standing and roles and responsibilities in the new drug and biologics approval, registration, and marketing process.
Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics submission process, including meeting requests, briefing materials and documentation, and dispute resolution. Technical and regulatory requirements for nonclinical, clinical, and chemistry and manufacturing portions of IND, NDA, BLA, and ANDA submissions are described, and the impact of key FDA Guidance documents explained.
Specific similarities and differences between the FDA and EMA are presented, especially major differences in technical requirements and regulatory authority, so that students understand the US FDA in the context of world-wide regulatory submissions. 

What do you gain?


  • Understand the structure of the FDA and the legal basis for the FDA’s role in US drug regulation
  • Understand the requirements and deadlines for written and oral communication with the FDA from the pre-IND through post-approval stages of drug and biologics submissions
  • Understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data that are submitted to the FDA
  • Understand how to use websites, especially, to research and retrieve important Guidance documents, legal action notices, and clinical trials information.
  • Understand key differences between FDA and EMA regulatory processes and requirements


  • Participate and lead teams in understanding and meeting FDA requirements for the study and registration of new drugs and biologics in the US
  • Prepare written meeting requests, draft questions, assemble background packages, and document interactions with the FDA
  • Advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics


  • Explain the structure of FDA and areas of legal responsibility
  • Identify and apply correct timelines for written and verbal FDA interactions
  • Identify where and how key information can be found
  • Recognize key differences between FDA and EMA requirements

Course dates

  •  6-8 June 2018

Exam dates

  • 31 August 2018 (online)

Application deadline

  • 9 May 2018

Applications will be processed by receipt, and applicants are admitted on a "first come, first served" basis. Registration will close when the maximum number of seats are taken. Applicants will be notified of admission within 4 weeks of submitted application.
Please note that the course
can be cancel or rescheduled if the number of participants fails to meet the required minimum.

Course fee

EU/EEA citizens Non EU/EEA citizens
Master student DKK 17.975 DKK 19.975
Single course student DKK 19.975 DKK 22.000