Educate to Innovate

Drug/Device Product Development and Regulation – Europe and US

Starting on September 7, 2020, a 4-week course (60-70 hours in total) jointly organized by EPFL and the College of Sciences, 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, enventual 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:

  • Describe the major steps of the drug and device development process from bench to bed-side.
  • Compare and contrast US and European Union regulatory and quality requirements.
  • Discuss 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.
  • Work with other life science professionals on a team.
  • Feel more confident about job seeking and job interviews.

The health care industry is knowledge-intensive, complex, globalized and highly regulated. This industry is comprised of drugs, biologics, biotech, medical devices and diagnostics. Advances in biotechnology, medical technology, and information technology give new hope for treating diseases never imagined before. To bring these advances from the laboratory bench to the patient bedside requires training and experience that are not available in academia. This course is intended to fill that gap. It is a four-week interactive course, involving intensive self-study and team-work. The course will bring you close to your future workplace. Experienced instructors 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. This can be extrapolated to Asia, Africa and Latin America as you will develop a mind frame to handle the shift.

The world’s regulatory, clinical and chemistry, manufacturing and controls (CMC), and medical technology arena is indeed complex, science-based and constantly changing. This graduate-level course covers the steps in the development and commercialization of drugs, biotech products and medical devices. It is designed to introduce regulatory and clinical professionalism to students having little or no exposure to industry. In addition, it will provide the “real world” knowledge and skills to develop solutions to multi-national regulatory and clinical problems.

This course will explore development strategy and regulations in their current status in many of the key areas of the world today. It will provide students with greater comprehension of the following main areas:

  1. The basic concepts of drug / device development.
  2. Regulatory and quality requirements in Europe and the USA.
  3. Skills in interacting with those in the profession and impinging professions in international environments.
  4. Exposure to the multitude of current and emerging professions in the healthcare industry.

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.

Week 1 – September 7
  • Presentation on drug development process.
  • Distribution and explanation of multiple-choice questions.
  • Distribution and explanation of case studies.
  • Assignment of groups with case studies and identification of group leaders.
Week 2 – September 14
  • Presentation on device development process.
  • Distribution and explanation of multiple-choice questions.
Week 3 – September 21
  • Quality management principles.
  • Distribution and explanation of multiple-choice questions.
Week 4 – September 28 ends on Oct 2
  • Case study presentations by group leaders.
  • Feedback by instructors.

Registered participants will receive details per mail.

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

Registration is open, please note you will need to pay directly in our system.

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

Registration deadline: August 17, 2020.

Contact

Program Director : Konstantinos Kaloulis

Office : AI 2240 

Mail : [email protected]  

Phone :  41 21 69 39521