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

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

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 Parag Shiralkar, 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 Venkat Lajapathirajan Venkateshwaran.Lajapathirajan@ppdi.com

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

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

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