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Join us for the CDISC User Group Meeting at Novartis. Explore topics on data standards, validation, and more. Next meeting in June 2017 - Volunteer to host!
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NJ CDISC Users Group Meeting Feb 27, 2017 Novartis Pharmaceuticals Corporation East Hanover, NJ
Welcome • Suggestions for future topics can be sent to any of the program committee members (see slide 3) • Next meeting planned for Jun, 2017 • We need a volunteer company to host the meeting • If your company is interested in hosting a meeting, please contact a program committee member
Welcome • 2017 program committee members • Ram Govindaraju, ram.govindaraju@wcct.com (Lead) • Max Kanevsky, mkanevsky@pinnacle21.net • Terry Katz, terry.katz@merck.com • Pat Majcher, patricia.majcher@novartis.com • ParagShiralkar, pshiralkar@eliassen.com • Sergiy Sirichenko, sergiy@opencdisc.org • Gina Wood, Georgina.wood@navitas.net • Tai Xie, tomx@brightech-intl.com • Saravanan Kandasamy: saravanank@navitas.net • Kumari Sai: kumari.sai@novartis.com • VenkatLajapathirajanVenkateshwaran.Lajapathirajan@ppdi.com
Agenda for Today • Presentations • What’s new in SDTM 1.5 – Mike DiGiantomasso (Pinancle) • Demo on creating ARM using P21E - Max Kanevsky (Pinnacle) • Networking opportunity, refreshments courtesy of Novartis • Practical considerations for data validation - Sergiy Sirichenko (Pinnacle) • Standards driven Oncology Studies (Response Criteria, CDISC) – Kevin Lee (Clindata Insight) • Closing
Presentations To Be Posted in CDISC Portal • Presentations will be posted • Go to www.cdisc.org • Click on CDISC Portal at the top of the screen • Click on CDISC User Groups, toward top left of the screen • Click on North America under Sites in the left hand panel • Click on Atlantic(Tri-State: CT, NJ, NY) under Sites in the left hand panel • Click on Presentations in the left hand panel • Click on folder 2017_02_meeting
Closing • Thank you • To our presenters • To our hosts at Novartis • To everyone attending • Next meeting planned: Jun, 2017 -- location TBD