Regulatory services, documents and data management

Thursday 31 March 2011 Electronic Laboratory notebooks

Opportunity to implement electronic Laboratory notebooks.

Friday 11 March 2011 Regulatory Affairs: Data Quality Management

The marketing of medicinal products in over 100 countries involves a rigorous und updated follow-up of the global Regulatory Affairs activity.

Friday 11 March 2011 eCTD : into an EDMS

Introducing eCTD format helped the global document management evolution.

Monday 07 March 2011 Variations: management in international context

Preparation of an important number of variations dossiers in an in-sourcing configuration on the Customer site.

Monday 07 March 2011 Preparation of long term archiving of documents

Having to cope with the increasing size of their archives and the obligation of long-term storage of certain sensitive documents, pharmaceutical companies are becoming interested in the electronic archiving of documents and the storage of their paper documents under the best possible conditions..

Monday 07 March 2011 Managing the development projects portfolio of an R&D organisation

How an integrated resource management and project management system allows better allocation of resources and activities within the R&D Department.

Monday 07 March 2011 Document management: installation of validated platform

How to define and launch a global EDMS, starting from the R&D’s EDMS.

Friday 04 March 2011 BPO of an administrative process: Contracts management

Complete outsourcing of the overall administrative management and accounting processes for a national coordination service newly created in the perspective to manage multiple contracts and related obligations.

Friday 04 March 2011 Change management: Preparation of documents and dossiers for regulatory submissions

To adapt the business process and tools to comply with Regulatory Submission regulation updates and to increase document preparation and management efficiency.

Friday 04 March 2011 Data management: analysis and extraction of data

Achieving compliance with the European Pediatric Regulation requires the compilation of the pediatric effects described in the marketing authorizations for all the medicines. The highly demanding timetable has forced certain laboratories to create a veritable task force.