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NJ CDISC Users Group Meeting

Join the CDISC User Group Meeting at Janssen Pharmaceutical for discussions on standards processes, technology, compliance, and validation. Future topic suggestions welcome!

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NJ CDISC Users Group Meeting

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  1. NJ CDISC Users Group Meeting Sep 15, 2016 Janssen Pharmaceutical (J&J company) Raritan, NJ

  2. Welcome • Suggestions for future topics can be sent to any of the program committee members (see slide 3) • Next meeting scheduled for Jan, 2016 • 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 • 2016 program committee members • Ram Govindaraju, ram.govindaraju@novartis.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 • Endpoint Adjudication in CDISC submission ; Jacques Lanoue & Aparna Kulkarni ; Novartis • Share some aspects of our history, current, and desired future state with regard to standards processes, technology, and change management; Gail Stoner; Janssen • Networking opportunity, refreshments courtesy of Janssen • Data de-identification standard for SDTM 3.2 endorsed by EMA in EMA Policy 0070 CSR Anonymization Guidance; Sherry Meeh; Janssen • Conformance, Compliance, and Validation: An ADaM Team Lead's Perspective; John Troxell; Accenture • 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 2016_09_meeting

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

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