The US Regulatory Environment

Course content

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.  The structure of the FDA and its relationship to the US government, international pharmaceutical companies, and the EMA is defined. 

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 and approvals.  Post approval areas regulated by the FDA including direct-to consumer advertising, life cycle management and risk management compliance, are discussed. 

Interactive web-based demonstrations are used to introduce students to the FDA website, navigate to critical areas of the website and retrieve information, and understand key concepts in drug marketing.  A group exercise of a mock interaction with the FDA reinforces the concepts discussed in the lectures. After completing the course, the student will have an overview of the FDA structure, specific recommendations for communicating with the FDA during all phases of drug and biologics development, and how regulatory affairs professionals can interact and lead drug development teams in obtaining approval for new drugs and biologics in the US.

Education

This course is offered in collaboration between University of Copenhagen and Atrium as an compulsory part of the Master of Medicines Regulatory Affairs.

 

See course calender for course dates

 

This course is compulsory at the 2016-curriculum

The course is open for single course student.

Learning outcome

After completing the course the student is expected to be able to:

Knowledge

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

 

Skills

  • 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 be the interface in the interactions with the FDA
  • Advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) guidelines on the study and registration of new drugs and biologics
  • Recognize key differences between FDA and EMA requirements

 

Competencies

  • Identify and apply correct timelines for written and verbal FDA interactions
  • Make descissions with regard to documentation necessary for maketing authorisations in the US
  • Review and assess documentation at all levels of the product development reflecting FDA's mindset
  • Evaluate and propose strategic scenarious on different regulatory pathways for various US situations

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. An interactive group exercise, supervised by the faculty, emphasizes many of the lecture topics, and provides an opportunity for students to participate in a mock interaction with FDA.
Besides lectures the students must prepare by reading the course literature

The syllabus comprises selected guidances, acts, etc. in the US and ICH. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to familiarize themselves with the syllabus, corresponding to approximately 1200 pages.

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English

Oral
Individual
Continuous feedback during the course of the semester
ECTS
5 ECTS
Type of assessment
Written assignment, 3 hours
3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.
Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assessment

To achieve the grade passed, the student shall (in an adequate level) be able to:

Knowledge

  • Explain the structure of the FDA and the legal basis for the FDA’s role in US drug and biologics regulation
  • Explain the structure of FDA and areas of legal responsibility
  • Explain the requirements and deadlines for written and oral communication with the FDA from the pre-IND through post-approval stages of drug and biologics submissionsExplain the specific regulatory requirements (cGLP, cGCP, cGMP) for data that are submitted to the FDA
  • Explain key differences between FDA and EMA regulatory processes and requirements
  • Identify where and how key information can be found

 

Skills

  • Recognize key differences between FDA and EMA requirements

 

Competencies

  • Identify and apply correct timelines for written and verbal FDA interactions
  • Make descissions with regard to documentation necessary for maketing authorisations in the US
  • Review and assess documentation at all levels of the product development reflecting FDA's mindset
  • Evaluate and propose strategic scenarious on different regulatory pathways for various US situations

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 89
  • Lectures
  • 22
  • Theory exercises
  • 5
  • Exam
  • 3
  • Exam Preparation
  • 18
  • English
  • 137