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, (Lead)
Max Kanevsky,
Terry Katz,
Pat Majcher,
Parag Shiralkar,
Sergiy Sirichenko,
Gina Wood,
Tai Xie,
Saravanan Kandasamy:
Kumari Sai:
Venkat Lajapathirajan

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