From bench to bedside - a fantastic voyage of drug/device development - Europe and US

 
CityLausanne, Lake Geneva region, Switzerland
CategoryPharmacology
Date Monday, until
Friday,
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

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?

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:

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

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