Educate for Life

Drug/Device Product Development and Regulation – Europe and US

Starting on August 30 2021, a 4-week course (60-70 hours in total) jointly organized by EPFL and the Center for Regulatory Science at the San Diego State University will be available online.  Experienced instructors from Europe and the US will introduce you to the fundamentals of drug/device development, and the requirements for regulatory and quality compliance. 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:

  • 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
  • Compare and contrast US and European Union regulatory and quality requirements
  • Develop tools to interaction with regulators
  • Understand the basics of a Quality Management System
  • Develop a Product Profile for a drug/device product or therapy
  • 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
  • Learn the art of successful cross-cultural communication
  • Feel more confident about job seeking and job interviews

Summary

  • This is a unique Swiss-American online course on Drug/Device Development and Regulation – Europe and US.
  • It brings together experienced lecturers/instructors for you from the heart of the high-tech San Diego Area and the Arc Lémanique high-tech belt. 
  • 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, San Diego State University.
  • The course is fully online and can be attended remotely. Virtual “meet-the-instructors” sessions with updates will be on August 30, September

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.

Drug development process and external case study on drug

Monday August 30, 2021 – 17:00 – 19:00 CET / 8:00 – 10:00 PT

Instructors: Gautam Maitra, Hasnaà Haddouk, Norma Schafer

  • Explanation of case studies and expectations.
  • Formation of teams with case studies and identification of group leaders.
  • Drug Development Process, Preclinical, clinical, CMC. EU
  • Overview of preclinical requirements – small molecules and biotech products
  • FDA organization product split CDER CBER, US regulatory Process for clinical trials, requirement for IND Phase 1 for biologics and small molecules

Device development process and external case study on devices

Monday September 6, 2021 – 17:00 – 19:00 CET / 8:00 – 10:00 PT

Instructors: Ary Saaman, Kim Walker

  • MDR, MedTech Regulatory landscape, Three Pillars – Technology, Biology, Clinical.
  • US Device Regulations and history

Role of quality compliance in the regulated industry

Monday September 13, 2021 – 17:00 – 19:00 CET / 8:00 – 10:00 PT

Instructors: Claude Ammann, Ajit Simh, Matthew Scherer

  • Role of Quality and Compliance
  • Quality as seen by the FDA
  • Quality for devices
  • US FDA, international engagement and the US-EU mutual recognition agreement

Wrap up and team case study reports

Sunday September 26, 2021 – 17:00 – 19:00 CET / 8:00 – 10:00 PT

Please note:

There will be two external case study presentations available on August 30 and September 06 on drug and device respectively. Students will be asked two questions on each external case study. The answers to the questions are expected on Sept. 05 and 12 respectively.

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

Registration will open before April 30, 2021

Registration deadline: August 13, 2021

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

Contact

Program Director: Gautam Maitra

[email protected]


+41794395956