The US Regulatory Environment

Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics development 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.

Course faculty have worked in the FDA or are individuals experienced in FDA interactions, and the lectures encourage students to understand, apply and integrate the topics and their applications in various regulatory situations. Each topic is supplemented with additional regulatory and technical references, to provide students with current literature. Web-based demonstrations provide real examples of important FDA specific topics.

During the course, you will get an understanding of the structure of the FDA and the legal basis for the FDA’s role in the US drug regulation, and the requirements and deadlines for written and oral communication with the FDA.

You will learn to understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data submitted to the FDA. Finally, you will learn to use relevant websites and understand the key differences between FDA and EMA regulatory processes and requirements.

You will be taught to participate and lead teams in understanding and meeting FDA requirements, and advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics.  

You will enhance your understanding of drug development processes to ensure alignment product alignment with FDA expectations

After the course, you will be able to prepare written meeting request, draft questions, assemble background packages, and document interactions with the FDA.

• David Horton, External Lecturer, Department of Pharmacy, University of Copenhagen and Director,  Abbvie USA
  • Steven B. Johnson, External Lecturer, Department of Pharmacy, University of Copenhagen and Head of Global Regulatory Affairs, UCB, USA