CDISC Standards Webinars

Latest Updates and Additions

 

Join our webinars each month for up to the minute hot topics from CDISC!  All 2012 webinars have free registration.  Topics will include updates from the standards teams, invited presenters from FDA and more!

Access to past webinars can be found at the bottom of this page.

 

2014 Webinar Schedule

Hold these dates for CDISC Webinars.  Please note date of webinars are subject to change.

CDISC Public Webinar Series - Standards Updates and Additions

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21 Aug 2014

11:00-12:30 PM ET

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Agenda

  • CFAST Update
  • Draft Analysis Results Metadata for Define-XML 2.0
  • Good Practice in PMA Submissions for Efficient Regulatory Decision Making

    • Abstract:

      In this talk I (Rajesh Nair, FDA) will discuss some of the highlights of the Medical Device User Fee amendment of 2012 (MDUFAIII) and the impact of MDUFA III goals on the review clock. The talk will provide a statistical reviewers perspective on how sponsor’s can help improve the efficiency of the FDA review process by submitting comprehensive “ready-to-review” submissions. Among the major issues faced by reviewers is that most of the study data submitted in PMA submissions is in non standard data formats and often not analysis ready. 

 

Speakers:

  • Rhonda Facile, CDISC
  • Monika Kawohl, Accovion GmbH
  • Lex Jansen, SAS
  • Rajesh Nair, FDA

 

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CDISC Public Webinar Series - Standards Updates and Additions

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25 Sep 2014

11:00-12:30 PM ET

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Agenda

  • Controlled Terminology, Batch 19 (Publication Release)
  • Controlled Terminology, Batch 20 (Public Review)
  • Others TBD
Panelists:
  • Bernice Yost, CDISC
  • TBD

 

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CDISC Members Only Mini-Training Series - Managing CDISC Version Changes

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2 Oct 2014

11:00-12:30 PM ET

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Agenda:

  • 60 Minute Webinar
  • 30 Minute Q&A Session
Panelists:
  • Lauren Shinaberry, Business & Decision
 

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CDISC Members Only Mini-Training: Null Flavors; A tool for handling missing and awkward data

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9 Oct 2014

11:00-12:30 PM ET

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Agenda:

  • 60 Minute Webinar
  • 30 Minute Q&A Session
Panelists:
  • Diane Wold, GSK
  • Others TBD

 

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CDISC Public Webinar Series - Standards Updates and Additions

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23 Oct 2014

11:00-12:30 PM ET

 

Agenda

  • TBD
Panelists:
  • TBD

 

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CDISC Public Webinar Series - Standards Updates and Additions

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20 Nov 2014

11:00-12:30 PM ET

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Agenda

  • TBD
Panelists:
  • TBD

 

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CDISC Members Only Mini-Training Series - Overview of handling of PK data in CDISC standards

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04 Dec 2014

11:00-12:30 PM ET

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Agenda:

  • 60 Minute Webinar
  • 30 Minute Q&A Session
Panelists:
  • Peter Schaefer, Certara
 

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CDISC Public Webinar Series - Standards Updates and Additions

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18 Dec 2014

11:00-12:30 PM ET

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Agenda

  • Controlled Terminology, Batch 20 (Publication Release)
  • Controlled Terminology, Batch 21 (Public Review)
  • TBD
Panelists:
  • Bernice Yost, CDISC
  • TBD

 

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CDISC Members Only Mini-Training Series - Overview on Define-XML and Dataset-XML

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15 Jan 2015

11:00-12:30 PM ET

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Agenda:

  • 60 Minute Webinar
  • 30 Minute Q&A Session
Panelists:
  • TBD

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CDISC Public Webinar Series - Standards Updates and Additions

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19 Mar 2015

11:00-12:30 PM ET

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Agenda

  • Controlled Terminology, Batch 21 (Publication Release)
  • Controlled Terminology, Batch 22 (Public Review)
  • TBD
Panelists:
  • Bernice Yost, CDISC
  • TBD

 

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Past Webinar Links

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Webinars accessible to the public:

 

Webinars accessible only to CDISC Members:

2014 Webinars

2013 Webinars

2012 Webinars

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