From bench to bedside - a fantastic voyage of drug/device development - Europe and US
Event details
| Date | 30.08.2021 › 27.09.2021 |
| Speaker |
Gautam Maitra, AC Immune Hasnaà Haddouck, Swedish Orphan Biovitrum Norma Shafer, Steadmed Mediacal Ary Saaman, Debiotech Claude Amman, Amman Consulting Ajit Simh, San Diego Matthew Scherer, FDA - Europe Office |
| Location |
online
|
| Category | Conferences - Seminars |
4-week fully online course (60-70 hours in total) 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.
Who can participate?
- Members of Swiss Academic Institutions with a minimum of a Bachelor degree, in a relevant field
- Members of early Start-ups, linked to a Swiss University, may be eligible; please contact the organizer
Practical information:
- Starts on August 30, 2021
- 4-weeks fully online interactive course with a total of 60-70 hours, including lectures, team-work and self-study
- Jointly organized by EPFL and the College of Sciences, San Diego State University
- Highly experienced instructors from Europe and US, including member of FDA
- Pricing: EPFL members 200 CHF, non-EPFL members 400 CHF
- Limited participants, first come first served
Why should you participate?
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.
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 pre-clinical 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
Practical information
- Informed public
- Registration required