we recruit immediately : experimented Junior Scientist

Thursday 12 August 2010

Friday 09 July 2010

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

Friday 09 July 2010

Document Editing and Document Management

eCTD: Taking what exists and inserting into GED Sunday 01 March 2009

The introduction of eCTD has helped overhaul document management

Client:

A major pharmaceutical laboratory, Department of International Regulatory Affairs.

Context:

Introducing the eCTD format into the presentation of marketing authorisation files and their versions, together with the deployment of a new GED system.

Objective:

• To improve consultation and accessibility of information in the client’s products.

• To allow future submissions to be made in eCTD format.

• In future, to introduce proper document life-cycle management.

Organisation of task:

• To identify the existing computer content in the current file system for the marketing authorisation files for 7 medicines, present them in eCTD format, and then transfer the whole into the new GED system.

• To carry out the checks and corrections necessary for the integrity of the content stored in GED in fine.

Resources applied:

• 1 Bac+5 diploma holder in foreign languages and scientific training in in-sourcing for 6 months.

• 1 regulatory expert in task monitoring, guaranteeing the quality of the deliverable from a (…) viewpoint

Results:

Task currently in progress.