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SUMMARY:Virtual Seminar on Phase I GMPs
DESCRIPTION:Early clinical trials are conducted to establish initial s
 afety of a drug.The studies are generally in small number of healthy s
 ubjects and use lower doses of the drug product.  Therefore, only sma
 ll amounts of investigational material are required. In order to not u
 ndertake substantial costs and to reduce regulatory burden during thes
 e early stages, the FDA has established guidelines to allow early stag
 e investigational products to be manufactured under less stringent GMP
 s.\nThis workshop will review the current regulations, guidance docume
 nts for early stage manufacturing and GMPs in detail.  Regulatory str
 ategies and logistical considerations for early development stage prod
 uct, including vendor selection and management, stability, labeling, a
 nd documentation requirements will also be reviewed and explored.\n\nW
 hy you should attend\nAttend this conference so that you may understan
 d differences between GMP requirements for early and later stage clini
 cal development.  Explore and discuss ways to develop and implement s
 trategies for early GMPs for phase I clinical studies.\nWho Will Benef
 it\n\nDirectors\nManagers\nSupervisors in Regulatory Affairs\nManufact
 uring\nQuality Assurance\nClinical Operations\n\nSpeaker Profile \nPe
 ggy J. Berry , MBA, RAC, is the President & CEO at Synergy Consulting
  where she provides consulting services to companies in all aspects of
  drug development. She also provides group and one-on-one training in 
 drug development, regulatory affairs and project management topics. Pr
 ior to founding Synergy Consulting in 2015, she was Vice President of 
 Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible
  for the development and implementation of global regulatory strategie
 s and the management and oversight of the regulatory affairs departmen
 t. Prior to Insmed, she was Vice President of Regulatory Affairs and Q
 uality at Amarin (3/2009-2/2014). \n\n\nFor more information visit ht
 tps://medtechiq.ning.com/events/virtual-seminar-on-phase-i-gmps
DTSTART;TZID=America/New_York:20190208T080000
DTEND;TZID=America/New_York:20190208T110000
CATEGORIES:virtual, seminar
LOCATION:Fremont
WEBSITE:http://www.globalcompliancepanel.com/virtual-seminar/6-hour-vi
 rtual-seminar-on-phase-i-gmps--10097LIVE?medtechiq-FEB-SEO-2019
URL:http://www.globalcompliancepanel.com/virtual-seminar/6-hour-virtua
 l-seminar-on-phase-i-gmps--10097LIVE?medtechiq-FEB-SEO-2019
CONTACT:18004479407
ORGANIZER;CN="John Robinson":https://medtechiq.ning.com/profile/JohnRo
 binson
ATTACH;FMTTYPE="image/jpeg":https://storage.ning.com/topology/rest/1.0
 /file/get/827574699?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN="John Rob
 inson":https://medtechiq.ning.com/profile/JohnRobinson
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