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PSDM Upcoming Events

PSDM Website make-over

The PSDM website has been completely re-designed. See www.psdm.nl instead.

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PSDM board vacancy

The PSDM is currently looking for an additional member to join their board (Data Management area).

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Recent PSDM Event:

Implementation of CDISC standardization - Pragmatic Approaches, Monday 14 Sep 2015,

Program


Abstracts and Bio's 14Sep15 Event

to event page

to abstracts


EFSPI Newsletters

EFSPI Newsletter for August 2015

Other EFSPI Newsletters


SAE DATA RECONCILIATION: What’s your approach?

 

SAE DATAa RECONCILIATION
What’s your approach?
 

Thursday May 22nd, 2008
 

Program

10.15

Coffee/tea 
10.45

Welcome
Anja Heukels, PSDM board member portfolio Data Management


11.00

SAE Reconciliation: Determining how much to reconcile, then and now at a small biotech
Jennifer Juntado, Intermune, Inc., Brisbane, CA, USA
Presentation
 
11.30

SAE Reconciliation: How to handle ‘a waterfall’ of SAEs?
Albert Hage, Astellas, Leiderdorp, The Netherlands
Presentation

12.00

New Approaches to SAE Reconciliation for Paper and EDC Studies: A Collaborative Perspective
Shannon Labout, CSS Informatics, Cambridge, MA, USA
Presentation

12.30- 13.30
Lunch
13.30

Handling and reconciliation of SAE data: a CRO perspective
Gerald Ruiter, IATEC, Amsterdam, The Netherlands
Presentation

14.00

SAE data entry: Clinical versus Pharmacovigilance standards
Daniel Becker, Solvay Pharmaceuticals, Hannover, Germany
Presentation

14.30

Coffee/Tea 

14.45

What’s your approach?

15.15

Plenary discussion
Shannon Labout, Albert Hage, Gerald Ruiter, Jennifer Juntado, Daniel Becker

16.00

Closure and drinks

hosted by Solvay Pharmaceuticals, Weesp

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