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SUMMARY:From bench to bedside - a fantastic voyage of drug/device developm
 ent - Europe and US
DTSTART;VALUE=DATE:20210830
DTSTAMP:20260916T203827Z
UID:54fcd7b37818ba82b7227f62c7d530f9c123ddba5f3eeb2ba39c1735
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 August 30\, 2021\n	4-weeks fully online interactive course with 
 a total of 60-70 hours\, including lectures\, team-work and self-study\n	J
 ointly organized by EPFL and the College of Sciences\, San Diego State Uni
 versity\n	Highly experienced instructors from Europe and US\, including me
 mber of FDA\n	Pricing: EPFL members 200 CHF\, non-EPFL members 400 CHF\n	L
 imited participants\, first come first served\n\n\nWhy should you particip
 ate?\n\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.\n\nStudents who successfully complete this
  course will be able to:\n\n	Describe the major steps of the drug and devi
 ce development process from bench to bed-side\n	Compare and contrast US an
 d European Union regulatory and quality requirements\n	Discuss the basics 
 of a Quality Management System\n	Develop a Product Profile for a drug/devi
 ce product or therapy\n	Draft the basic components of a Development Plan f
 or a Phase 1 clinical trial\, including a pre-clinical Plan\, a Clinical T
 rial Protocol\, and CMC (Chemistry\, Manufacturing and Controls) Plan\n	Wo
 rk with other life science professionals on a team\n	Feel more confident a
 bout job seeking and job interviews\n
LOCATION:online
STATUS:CONFIRMED
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