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  • Tokyo 5-6 November 2018
    Tokyo 5-6 November 2018
  • Paris, France 23-25 October 2018
    Paris, France 23-25 October 2018
  • Philadelphia, USA 2-4 October 2018
    Philadelphia, USA 2-4 October 2018
  • Princeton 1-3 May 2018
    Princeton 1-3 May 2018
  • Darmstadt, 15-17 May 2018
    Darmstadt, 15-17 May 2018
  • Tokyo 4-5 December 2017
    Tokyo 4-5 December 2017
  • Wellesely, MA 16-18 October 2017
    Wellesely, MA 16-18 October 2017
  • BERLIN 26-28 SEP 2017
    BERLIN 26-28 SEP 2017
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    REYKJAVIK 8-10 MAY 2017
  • BLUE BELL, PA 24-26 OCT 2016
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  • SINGAPORE 1-3 JUNE 2016
    SINGAPORE 1-3 JUNE 2016
  • UPPSALA 17-19 MAY 2016
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  • INDIANAPOLIS 25-27 APR 2016
    INDIANAPOLIS 25-27 APR 2016
  • NEW YORK 19-21 OCT 2015
    NEW YORK 19-21 OCT 2015
  • HORSHAM 5-7 OCT 2015
    HORSHAM 5-7 OCT 2015
  • SINGAPORE 3-4 SEP 2015
    SINGAPORE 3-4 SEP 2015
  • NORTH WALES, PA 18-20 MAY 2015
    NORTH WALES, PA 18-20 MAY 2015
  • SIENA 28-30 APR 2015
    SIENA 28-30 APR 2015
  • BANGALORE 5-6 FEB 2015
    BANGALORE 5-6 FEB 2015
  • CAMBRIDGE, MA 22-24 OCT 2014
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  • COPENHAGEN 16-18 SEP 2014
    COPENHAGEN 16-18 SEP 2014
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    SINGAPORE 20-21 MAY 2014
  • AMSTERDAM 14-16 MAY 2014
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    BOULDER 30 APR - 2 MAY 2014
  • RESTON, VA 28-30 OCT 2013
    RESTON, VA 28-30 OCT 2013
  • DUBLIN 18-20 SEP 2013
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  • KASNSAS CITY 7-9 MAY 2013
    KASNSAS CITY 7-9 MAY 2013
  • EDINBURGH 22-24 APR 2013
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  • MONTVILLE, NJ 14-16 NOV 2012
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  • MADRID 1-3 OCT 2012
    MADRID 1-3 OCT 2012
  • PARIS 21-23 MAY 2012
    PARIS 21-23 MAY 2012
  • EAST HANOVER, NJ 7-8 MAY 2012
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    STRASBOURG 28-30 NOV 2011
  • NEWPORT BEACH 2-3 NOV 2011
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  • BANBURY 4-6 MAY 2011
    BANBURY 4-6 MAY 2011
  • CAMBRIDGE, MA 12-13 APRIL 2011
    CAMBRIDGE, MA 12-13 APRIL 2011
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    FORT LAUDERDALE 3-5 NOV 2010
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    BRUSSELS 6-8 OCT 2010
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    PARIS 5-7 MAY 2010

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BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Offered twice: Wed March 14 2018 for one hour at UCT 0800 and UTC 1700

Event date: 3/14/2018 Export event

BoF Discussion: Direct Access to Sponsor’s Systems used in Clinical Investigations

Facilitated by Cinzia Piccini, Eli Lilly & Co

According to ICH E6, direct access should be granted to regulatory inspectors to examine, analyze, verify and reproduce any records and reports that are important to evaluation of a clinical trial. What are the considerations and challenges to grant such access in the Sponsor’s systems (e.g. eTMF, EDC, eCRF, ePRO, IVRS…)? Are there different approaches according to the type of systems (on-line/off-line), locations of the inspection (site vs. sponsor vs CRO)?  What should sponsor expect from regulatory inspectors (e.g. being trained, hardware/software configurations etc.). Participants are encouraged to share their ideas and experiences!!  

Time: This BoF is offered at 2 times in order to accommodate eCF members from around the world:  March 14 at UTC 0800 and March 14 at UTC 1700

This BoF Discussion is open to all from eCF Member companies. Please contact suzanne.bishop@eclinicalforum.org to register for this BoF or for information on eCF membership.  If you are not a member and would like more information on all the eClinical Forum member benefits, see the membership tab on this site or contact info@eclinicalforum.org and we will be happy to set up a phone meeting to discuss how your organization might fit with eClinical Forum.

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11/5/2018 - 11/6/2018 UTC
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AGENDA AVAILABLE: eClinical Forum Asia-Pacific 2018 Workshop in Tokyo, 5-6 November 2018

Our next meeting of the eClinical Forum Asia-Pacific will take place in Tokyo, 5-6 November 2018 and is kindly hosted by Boehringer Ingelheim - Japan. An outline agenda and registration details are available...

Read more
6
11/5/2018 - 11/6/2018 UTC
63

AGENDA AVAILABLE: eClinical Forum Asia-Pacific 2018 Workshop in Tokyo, 5-6 November 2018

Our next meeting of the eClinical Forum Asia-Pacific will take place in Tokyo, 5-6 November 2018 and is kindly hosted by Boehringer Ingelheim - Japan. An outline agenda and registration details are available...

Read more
7
11/7/2018 UTC
69

Birds-of-a-Feather Discussion:  Industry Adoption of RBM after ICH-E6(R2)

Date:    Wed, Nov 7 2018 at UTC 07:00  -- Presenter Abby Abraham, OmniComm Systems

              Wed, Nov 17 2018 at UTC 16:00 – Presenter Ken Light, OmniComm Systems

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11/14/2018 UTC
69

Birds-of-a-Feather Discussion:  Industry Adoption of RBM after ICH-E6(R2)

Date:    Wed, Nov 7 2018 at UTC 07:00  -- Presenter Abby Abraham, OmniComm Systems

              Wed, Nov 17 2018 at UTC 16:00 – Presenter Ken Light, OmniComm Systems

Read more
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