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eCTD submission, Dossier outsourcing

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Opening Pandora's box - a discussion on opening your Regulated systems to the outside world? Friday 09 July 2010

The transformation of the pharmaceutical business model from one which is isolated and insulated from the outside world to one which must open up and share key information with a range of third party companies, e.g. CROs, CMOs etc, is one which is challenging the teams responsible for protecting and managing the core documentation of a company.

In this talk we look at ways that the validated EDMS system can be opened up for secure collaboration with partner companies An area of particular interest is the use of Portals.

The discussion shares the experiences of one company  in building the business case, and discussing the contrasting demands from the different groups involved in the project.

 

Agenda:

8:30 : Registration & coffee

10:30 : Questions to the speakers

11:00 :  Open discussion

 

CONDITIONS : 

The attendance is free of charge. Please register early, because the seats are limited.

Please Confirm your presence

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Focus

Outsourcing electronic submission filing: From strategy to training, from consultancy to services

Managing the development projects portfolio of an R&D organisation

eCTD: Taking what exists and inserting into GED

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