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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

eCTD - Electronic submissions

Outsourcing electronic submission filing: From strategy to training, from consultancy to services Monday 02 March 2009

How a dermatology company implemented eCTD while centralizing the management of publishing activities and outsourcing eCTD production

Client:

A mid size pharmaceutical company.

Department: The global regulatory affair.

Context:

Publishing and submission are managed from 3 different sites for, with many variations. The company wants to achieve a centralized creation and management of all submissions worldwide, following an "eCTD minded" approach.

Objective:

• Analysis of the as-is situation. Challenges on the today strategy.
• Definition  of the tools required and training action.
• Evaluate externalization options (submission, variations…).

Mission organization:

Strategic consultancy:

• Challenge the actual situation. Identify the risks. Identify key questions.
• Set up the training needs and the training programs. Select the appropriate software tools.

Outsourcing Services:

• Analyse eCTD issues. Train the internal team on the new tools and new processes.
• Propose the outsourcing of the submission and variation files (according to the identified needs).

People:

• 1 senior consultant in regulatory tracking
• 1 english speaking consultant with scientific background
• 1 regulatory affair expert responsible for the delivery

Results: