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.

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 YOU WILL LEARN

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and lead teams in understanding and meeting FDA requirements, and advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics.

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

COURSE CONTENT

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.

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.

PARTICIPANTS

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

COURSE DETAILS

Course dates

3 days, 12-14 June 2019

Course fee

EU/EEA citizens/Master student DKK 18,275

Non EU/EEA citizens/Master student DKK 20,275

EU/EEA citizens/Single course student DKK 20,275

Non EU/EEA citizens/Single course student DKK 22,300

Application deadline

14 May 2019

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.

EXAMINATION

3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.

Credit

4 ECTS

Examination date

28 August 2019 from 10:00 - 13:00 on the Digital Exam platform.