Starting on October 14, 2019, a 4 week online course is jointly organized by the School of Life Sciences, EPFL, and the College of Sciences, San Diego State University :
“FROM THE LAB BENCH TO THE BEDSIDE – A FANTASTIC VOYAGE OF DRUG/DEVICE DEVELOPMENT”
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.
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.
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 course is open to all members of Swiss Academic Institutions. Minimum of a Bachelor degree, in a relevant field, is required to participate
• Members of early start ups, strictly linked to a Swiss University, may be eligible; please contact the organizer
• Price for Non EPFL members is 400 CHF, Price for EPFL members is 200 CHF, Payment online shall be possible from September
• There are limited places; 1st come, 1st served
• Deadline is September 30
Program Director : Kostas Kaloulis
Email : firstname.lastname@example.org