Friday 09 July 2010

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

Friday 09 July 2010

“The challenges of Market Access” Marc Czarka

Friday 09 April 2010

News-Events

Pharmacovigilance Seminar Monday 16 November 2009

Pharmacovigilance is a vital function for pharma manufacturers. Increasing demands for transparency and changes in the guidelines for proactive risk management and the electronic submission of adverse event reactions (ADRs) are having a significant impact both on practices and associated information systems.

Therefore we would like to invite you to our workshop that will lead you within a compressed and a bit more than 2 hours through pestering questions of pharmacovigilance and drug safety monitoring.

During this event we will show, how your risks are managed today as well as an outline on future requirements. In the second part of the workshop you will see a user friendly workflow of ADR management (from entering through electronic agency communicatioin) with our software solution PcVmanager. In France many pharmaceutical companies as well as the AFSSAPS are using EXTEDO solutions.

We are very pleased that Dr. Erick Gaussens and Dr. Reinhard Nibler confirmed as a speaker. Dr. Gaussens has more than 10 years of experience as a consultant for Pharma R&D, encompassing topics like eCTD, PLM, eDMS and Pharmacovigilance. Dr. Nibler has a longstanding experience in pharmacovigilance and is EU QPPV for several companies. He is president of the Middle European Society for Regulatory Affairs (MEGRA).

Agenda (presentations will be held in English):

10:00: Registration & coffee

10:30: Welcome and EXTEDO company presentation (Schei Dattner, EXTEDO)

10:45: Risk Management and the future of Pharmacovigilance (Dr. Erick Gaussens, ProductLife)

11:30: EXTEDO PcVmanager software demonstration (Dr. Reinhard Nibler, Dr. Nibler & Partner )

12:30: Questions to the speakers

12:45: Open discussion

Meeting location:

Les Salons de l'Aéro-Club de France, 6 rue Galilée, 75116 Paris, France

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CONDITONS :

The attendance is free of charge. Please register early, because the seats are limited.

Registration by e-mail: If you would like to participate, please send an e-mail to Thomas Kessler before 11/11/09, kessler@extedo.com . (Required information: Name, company, position, e-mail address, telephone number