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

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Event details

Date and time 07.09.2020 02.10.2020  
Place and room
Online
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
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 September 7, 2020
  • 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: non-EPFL members 400 CHF, EPFL members 200 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
 
More info and registration

Practical information

  • Expert
  • Registration required

Tags

regulatory affairs life sciences innovation industry

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