Educate to innovate

Drug/Device Product Development and Regulation – Europe and US

Starting on October 14, 2019, the 4 week course is jointly organized by EPFL and the College of Sciences, San Diego State University.   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.

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 introductory course, it is general in nature and will have an emphasis on 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.

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 his/her group (5-10 pages in length, double-spaced, not including references). The template will be provided for the Project Report.

Week 1 – October 14

  • Presentation on drug development process.
  • Distribution and explanation of multiple-choice questions.
  • Distribution and explanation of target product profile.
  • Distribution and explanation of case studies.
  • Assignment of groups with case studies and identification of group leaders.

Week 2 – October 21

  • Presentation on device development process.
  • Distribution and explanation of multiple-choice questions.

Week 3 – October 28

  • Quality management principles.
  • Distribution and explanation of multiple-choice questions.

Week 4 – November 4

  • Case study presentations by group leaders.
  • Feedback by instructors.

In-person training of students in Switzerland at EPFL Room BM5202 will take place on  October 14, 21, 28 and November 4 from 13:30-19:30 by our Swiss Instructors.

American instructors are purely online via Blackboard, registered participants received details per mail.

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

Register here, please note that our system requires that registration and payment are made at the same time, your place will be confirmed after receipt of the payment.

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

Registration deadline: September 23, 2019.

Contact

Program Director : Konstantinos Kaloulis

Office : AI 2240 

Mail : [email protected]  

Phone :  41 21 69 39521