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NJ CDISC Users Group Meeting

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

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NJ CDISC Users Group Meeting

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  1. NJ CDISC Users Group Meeting Feb 27, 2017 Novartis Pharmaceuticals Corporation East Hanover, NJ

  2. 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

  3. 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

  4. 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

  5. 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

  6. Closing • Thank you • To our presenters • To our hosts at Novartis • To everyone attending • Next meeting planned: Jun, 2017 -- location TBD

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