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SUMMARY:Drug and Devices Development: Level1
DTSTART:20181105T140000
DTEND:20181107T180000
DTSTAMP:20260407T050951Z
UID:d194efb3a500b0a02cc7c9b93e672c696acc86e7d3ec6fcc1a043777
CATEGORIES:Internal trainings
DESCRIPTION:Gautam Maitra\, (San Diego State University & AC Immune SA)\, 
 -  Ary Saaman\, (Debiotech SA)\, -  Claude Ammmann\, (Claude Ammann Cons
 ulting SA)\, -  (Dirk Vocke\, Innovation\, Merck Group)\, -  (Kostas Kal
 oulis\, Catalyze4Life\, EPFL)\nDear Colleagues\, \nCatalyze4Life (https://
 catalyze4life.epfl.ch/) is happy to announce the 1st Workshop on the Devel
 opment of Drugs and Medical Devices.\nCome and learn from industry experts
 \, how your technology can be turned into a product\, and additionally map
  your career options\, by familiarizing with concepts like: \n\n	Process 
 map to product development and regulatory approval of drugs and devices \
 n	Project simulation with case studies\n	Team/groups work\n	This workshop 
 is limited to 40 participants as it shall be highly interactive. Please ma
 ke\n	Certificates of attendance shall be provided at the end of the course
 . Please make sure you follow all the course.\n	Registration is compulsory
  at https://epfl.doodle.com/poll/rcff5aa3cv9deykp\n\nPlace: The Workshop s
 hall take place at SV 1717\, https://plan.epfl.ch/?room==SV 1717\nFormat: 
 1.5h presentation followed by 1.5h case studies in groups \nThe content o
 f the 3 days of the workshop is interconnected.\nSchedule:\nDay 1 (Novembe
 r 05\, 2018\, 14:00-17:00)\nIntroduction to Drug Development:\nPreclinical
 \, CMC\, clinical\, glossary of terms\, definitions of drug\, device\, des
 cription of the flow of work\, with explanation of the basic tasks from di
 scovery to clinical trial submission (IND/CTA) to market\,  Market Author
 ization Application (MAA/NDA)\, and post-marketing surveillance (Life Cycl
 e Management). \nDay 2 (November 06\, 2018\, 14:00-17:00):\nClinical Tria
 ls Phase 1 to 3 and GxP Compliance\n(IND/CTA) \nDay 3 (November 07\, 2018
 \, 14:00-17:00):\nMedical Devices:\nIntroduction to the medical device des
 ign and development process and regulatory clearances/approvals (EU and US
 A). Emphasis on devices for drug delivery.\n \nExpectations from Particip
 ants:\n1.            Read background material provided\n2.  
           Stay alert\n3.            Show engagement\n4
 .            Have an open mind\n5.            Work i
 n teams\n \nThe Instructors \n\n\n	Gautam Maitra\, Instructor\, Faculty 
 Advisory Board Member\, Center for Regulatory Sciences\, College of Scienc
 es\, San Diego State University\n	Claude Ammmann\, Director Claude Ammann 
 Consulting\, Lausanne\n	Ary Saaman\, Director\, Regulatory Affairs\, Debio
 tech SA\, Lausanne\n	Dirk Vocke\, Director\, Innovation\, Merck Group\, Ge
 rmany\n	Kostas Kaloulis\, Director\, Catalyze4Life\, EPFL\, Switzerland\n\
 nKey facts on regulatory affairs and drug/device development:\n\n\n	Origin
 ators in the pharmaceutical industry contribute 60 percent of the industry
 ’s global gross value added and 42 percent of its employment (IFPMA Repo
 rt)\n	The number of people employed worldwide in the pharmaceutical indust
 ry is roughly equivalent to total employment in Belgium (IFPMA Report)\n	W
 ages and salaries per employee rose by USD 3\,000 to USD 20\,600 between 2
 006 and 2012\, an increase of 16.6 percent (IFPMA Report)\n	Gene therapy m
 ay disrupt the sector by offering customized\, targeted patient treatment 
 (2018 Global Life Sciences Outlook)\n	About 200 3D-printed devices have be
 en approved in the last decade that can be tailored to fit a patient’s a
 natomy (2018 Global Life Sciences Outlook)\n\nKeywords : DHF = Design Hist
 ory File\, DMR = Device Master Record\, EU MDR = European Medical Devices 
 Regulation\, Notified Body\, CE-marking\, US FDA = US Food and Drug Admini
 stration\, 510(k) dossier\, PMA = Premarket Approval\, Combination Product
 s\, « safety and effectiveness \nLooking Forward to seeing you there\, 
 \nDr Kostas Kaloulis & Prof Bart Deplancke
LOCATION:SV 1717 https://plan.epfl.ch/?room==SV%201717
STATUS:CONFIRMED
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