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2005 Privacy Act Conference - Montreal, Quebec
Aligning Life Science's IT with 21 cfr part 11 requirements
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June 1-2, 2005

Laurent Féral-Pierssens will host a lunch breakout session during the 2005 Privacy Act Conference on June 2nd.

Aligning Life Science's IT with 21 cfr part 11 requirements

During the late 1990’s, pharmaceutical companies were focused on reduction of R&D cycle time through improved submission processing. At that time, this focus tended to be around the collection and publication of documents just prior to submission preparation (of paper submissions). Little attention was given to the development of reports.

Since the introduction of electronic submissions and 21CFR Part 11 (21CFRp11) requirements, companies have developed a new focus on the preparation of e-submissions and the planning for implementation of the eCTD. Focus has shifted to technology implementation, standardized authoring, data organization (such as SAS) and computer system validation (CSV). Document management to support submissions, and/or due diligence activities is as critical as ever and for many companies, is the fundamental required to protect their electronic documents.

About Laurent Féral-Pierssens

Mr. Féral-Pierssens has a background in Computer Sciences and Mathematics from McGill University (Montréal). Since 2000, he has founded and is president of DistinctHorizon Corporation, a software company dedicated in Regulated Information Management for the Life Sciences and Pharmaceutical Industries.

Mr. Féral-Pierssens has been lecturing at McGill University on the topic of Information Systems and has worked previously in the United-States, France and Canada as an Information Systems Software Engineer.

Through the years as DistinctHorizon's President, Mr. Féral-Pierssens has been involved in the design and architecture of FDA compliant Information systems, Clinical Trial Management and Monitoring Software and Electronic Data Capture for e-CRF. Market Intelligence initiative in Canada, United-States and Canada.


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