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CTD/eCTD and 21 CFR Part 11 ( May 2002): Seminar held in Frankfurt, Germany, a huge success

May2002

21

Frankfurt - May 21st 2002

Lorenz Archiv-Systeme GmbH, the premier provider of submission management solutions for the Life Sciences sector, held a seminar on the Common Technical Document (CTD/eCTD) and 21 CFR Part 11 compliance on May 14th 2002.

The seminar proved a huge success. Over sixty attendees ranging from smaller biotech to large pharmaceutical organizations, CROs, consultants as well as members of various regulatory bodies attended the meeting.

Supported by the leading pharmaceutical associations, (Verband Forschender Arzneimittelhersteller, Bundesverband der Pharmazeutischen Industrie, Deutscher Generika Verband e.V.), the seminar provided an overview into the requirements for moving towards the CTD as well as critical issues within organisations to maintain 21 CFR Part 11 compliance.Regulatory Affairs consultants highlighted scientific and organizational challenges for the pharmaceutical industry.

Dr. Lautz, Bayer AG, presented his experiences of his last project for a centralized procedure using docuBridge™ publishing an electronic submission using eCTD technology.

Dr. Menges, BfArM, described Germany’s authority perspective on the CTD/eCTD.

Sebastian Mueller-CrÈpon, Adobe Systems, provided an overview on electronic signatures, concepts as well as their implementation.

Lorenz demonstrated compiling a sample CTD dossier and eCTD publishing using docuBridge™.All presentations, and especially BfArM's overview, were followed by many questions. An intensive discussion with all participants closed a highly successful and informative day.

"... thank you for the excellent seminar …I have learned a lot," said Sven Harmsen, Fujisawa GmbH.

"Overall, the seminar has provided a good overview of the upcoming challenges to the regulatory affairs departments - nationally as well as internationally," says Wolfgang Witzel, executive partner for Lorenz in Germany. "The heightened interest in this area has led us to plan further seminars that tackle same and similar challenges."

The seminar took place at the Lorenz Group headquarters in Frankfurt, Germany.