Educate4Life

Drug/Device Product Development and Regulation – Europe and US

Welcome to Educate4Life, a course organized by EPFL Catalyze4Life. The course starts on August 22 and ends on September 30, 2022. This is a 6-week intensive, case study-based course (60-70 hours in total).  The course is expected to be hybrid – both online and in person. Experienced instructors will introduce you to the fundamentals of drug/device development, the requirements for regulatory and quality compliance, Intellectual Property, Project Management and Managing Cultural Diversity in Technical and Scientific Professions. You will have exposure to the requirements in Europe and the US in terms of the approach, the attitude to risk-taking, and the cultural divide.

EPFL recommends 2 ETCS for its EDCH PhD students. As the course is not part of the EPFL course book, eventual PhD participants should make sure they enroll following the internal requirements of their doctoral program (in parallel to the online registration).

Students who successfully complete this course will be able to:

  1. Understand the major steps of the drug and device development process through cross-functional teamwork and report writing with pre-set deadlines, reflecting real-life situation of challenges at work in industry.
  2. Compare and contrast US and European Union regulatory and quality requirements (major markets setting best practices and standards).
  3. Develop tools to interaction with regulators.
  4. Understand the basics of a Quality Management System.
  5. Develop a Product Profile for a drug/device product or therapy.
  6. Draft the basic components of a Development Plan for a Phase 1 clinical trial, including a Preclinical Plan, a Clinical Trial Protocol, and CMC (Chemistry, Manufacturing and Controls) Plan.
  7. Master the basics of early stage Project Management skills.
  8. Learn the essentials of Intellectual Property Rights.
  9. Learn the art of successful cross-cultural communication.
  10. Feel more confident about job seeking and job interviews.

Summary

  • This is a unique 6-week course on Drug/Device Development and Regulation – Europe and US.
  • Students will have the real-world experience of working across classical pharma/MedTech company departments with intensive team work, discussion of week’s material, enabling them to write the Case Study Reports. Expect approximately 2-3 hours of work daily.
  • On successful completion, the course participants will receive a Certificate of Attendance from EPFL.
  • Besides, the course participants are entitled to 2 ECTS from EPFL by applying through department channels.
  • The course is fully online and can be attended remotely. The “meet-the-instructors” sessions with updates will be on August 25, September 1, 8, 15, 22, and ending on September 29, 2022, pertaining to dedicated weekly tasks.

Detailed description

As an academia-industry bridging strategy, the course has an emphasis on the importance of regulations, conventional fundamentals and ways to incorporate current industry trends like translational medicine and digital health. The course will have an emphasis on what it takes to bring the product from the lab-bench to the bedside in clinical trials. We will focus more on Europe and US, where it is likely you will have your first and most frequent interaction(s). This course will strengthen your confidence during the first and subsequent exploration of the work world to land in the right job. It will also serve as a resource for the future when you may be called upon to work internationally.

The students are highly encouraged to bring their own case study projects as long as the projects fit into a standard development plain to aim fro the clinical trial phase 1 or 2 (Europe and US). Though the course is the same for all students, for the project work, the students need to make a choice between drug and device on the first day of the course (the latest), the students will then be divided into groups. The groups need to select a leader who will lead the discussions on the Discussion Board all throughout the 4-weeks leading to a team project report.

Each group leader is expected to submit the team project report with input from their group (5-10 pages in length, double-spaced, not including references). A template will be provided for the Project Report.

The course instructors are drawn from European and US Biotech and Medtech industry and an officer from the US FDA stationed in Europe.

You will need at least a Bachelor degree in any area of Life Sciences to register to the course.

Registration deadline: extended to August 19, 2022

Course fee: 200 CHF for EPFL members, 400 CHF for non-EPFL members