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DTSTART:19700308T020000
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UID:2140535:Event:62046
DTSTAMP:20260522T224447Z
SUMMARY:Managing Mid-Study Changes in Clinical Studies: Best Practices
DESCRIPTION:This clinical trial compliance webinar will discuss common
  challenges and practical suggestions for mid-study changes. It will u
 se a case-study approach to explain the best practices for mid-study c
 hanges.\n\nWho will Benefit:\nThis webinar will provide valuable infor
 mation to\n\nSponsors for clinical trials\nInvestigators and sites par
 ticipating in clinical trials\nClinical trial personnel such as projec
 t managers, CRAs, clinical coordinators\nIRB personnel\nRegulatory Vic
 e Presidents, Directors and Managers at sponsors\nAttorneys – In-hou
 se or Outside Counsel\n\nInstructor Profile:\nDr. Mukesh Kumar, is a 
 Washington DC-based consultant in regulatory affairs and quality assur
 ance for manufacturers and developers of FDA-regulated products. He an
 d leads the Regulatory Affairs and Quality Assurance departments at Am
 arex, a full service pharmaceutical product development company based 
 in Germantown, MD. His key expertise is in regulatory affairs, clinica
 l trials and multi-national project management for medicinal and diagn
 ostic products. He has been involved in about 100 clinical trials in m
 ore than 40 countries, has made several hundred US FDA submissions, an
 d arranged a number of meetings with the US FDA. In addition, he has h
 ad made regulatory submission in the EU and India. He has conducted GC
 P, GLP, GMP and GACP audits in the US and several countries in Europe 
 and Asia. He has conducted numerous training workshops in FDA complian
 ce related issues. He has authored numerous articles in peer-reviewed 
 journals. He is a well known expert in global regulatory affairs and h
 as been an invited speaker at several professional and academic organi
 zations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked a
 s a research scientist at the NIH, Baylor College of Medicine, Houston
 , and premier institutions in India. He is a certified regulatory affa
 irs professional by the Regulatory Affairs Professional Society, USA.\
 n\nFor more information visit https://medtechiq.ning.com/events/managi
 ng-mid-study-changes-in-clinical-studies-best-practices
DTSTART;TZID=America/New_York:20130904T100000
DTEND;TZID=America/New_York:20130904T110000
CATEGORIES:webinar
LOCATION:Online Event
WEBSITE:http://www.complianceonline.com/ecommerce/control/trainingFocu
 s/~product_id=703043?channel=meditechiq
URL:http://www.complianceonline.com/ecommerce/control/trainingFocus/~p
 roduct_id=703043?channel=meditechiq
CONTACT:16506203915
ORGANIZER;CN=ComplianceOnline:https://medtechiq.ning.com/profile/Refer
 ral512
ATTACH;FMTTYPE="image/jpeg":http://storage.ning.com/topology/rest/1.0/
 file/get/2562006613?profile=original
ATTENDEE;ROLE=REQ-PARTICIPANT;PARTSTAT=ACCEPTED;RSVP=TRUE;CN=Complianc
 eOnline:https://medtechiq.ning.com/profile/Referral512
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