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SUMMARY:From bench to bedside - a fantastic voyage of drug/device developm
 ent - Europe and US
DTSTART;VALUE=DATE:20200907
DTSTAMP:20260916T203830Z
UID:351d38a28cdf4d0bf679ee26fbf2c4674e0472e6940781fe345b40cf
CATEGORIES:Conferences - Seminars
DESCRIPTION:Gautam Maitra\, AC Immune\nHasnaà Haddouck\, Swedish Orphan B
 iovitrum\nNorma Shafer\, Steadmed Mediacal\nAry Saaman\, Debiotech\nClaude
  Amman\, Amman Consulting\nAjit Simh\, San Diego\nMatthew Scherer\, FDA - 
 Europe Office\n4-week fully online course (60-70 hours in total) jointly o
 rganized 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 regulat
 ory 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.\n\nWho can participate? \n\n	Members of Swiss Ac
 ademic Institutions with a minimum of a Bachelor degree\, in a relevant fi
 eld\n	Members of early Start-ups\, linked to a Swiss University\, may be e
 ligible\; please contact the organizer\n\n\nPractical information: \n\n\n	
 Starts on September 7\, 2020\n	4-weeks fully online interactive course wit
 h a total of 60-70 hours\, including lectures\, team-work and self-study\n
 	Jointly organized by EPFL and the College of Sciences\, San Diego State U
 niversity\n	Highly experienced instructors from Europe and US\, including 
 member of FDA\n	Pricing: non-EPFL members 400 CHF\, EPFL members 200 CHF\n
 	Limited participants\, first come first served\n\n\nWhy should you partic
 ipate?\nAdvances in biotechnology\, medical technology\, and information t
 echnology give new hope for treating diseases never imagined before. To br
 ing these advances from the laboratory bench to the patient bedside requir
 es training and experience that are not available in academia\, this cours
 e is intended to fill that gap.\nStudents who successfully complete this c
 ourse will be able to:\n\n	Describe the major steps of the drug and device
  development process from bench to bed-side\n	Compare and contrast US and 
 European Union regulatory and quality requirements\n	Discuss the basics of
  a Quality Management System\n	Develop a Product Profile for a drug/device
  product or therapy\n	Draft the basic components of a Development Plan for
  a Phase 1 clinical trial\, including a pre-clinical Plan\, a Clinical Tri
 al Protocol\, and CMC (Chemistry\, Manufacturing and Controls) Plan\n	Work
  with other life science professionals on a team\n	Feel more confident abo
 ut job seeking and job interviews\n\n \nMore info and registration \n\n\n
 	Catalyze4Life - Educate to innovate\n	Pre-registration\n	Contact program 
 director Kostas Kaloulis catalyze4life@epfl.ch  \n
LOCATION:Online
STATUS:CONFIRMED
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