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Miles
Km80.5

   

eRA 2011 Europe Hosted by EXTEDO Covered Wide Range of Regulatory Affairs Topics


5/11/2011 8:35:58 AM

MUNICH, GERMANY and OTTOBRUNN, GERMANY--(Marketwire - May 10, 2011) - EXTEDO, a key eRegulatory Affairs solutions provider for life sciences firms, hosted eRA 2011 Europe, an eRegulatory Conference, at the Galatzo Hotel in Peguera, Majorca, Spain on April 13 through April 14, 2011.

135 executives from a cross section of the life sciences industry attended the event this year, including 30 executives from various regulatory authorities. The event featured presentations from 35 domain experts on a wide range of topics including Submission Planning and Tracking, Worldwide Standards and Interoperability, Core-Dossier Management, and Pharmacovigilance in a new era.

The two-day event provided attendees with a unique opportunity to network with industry experts, regulators, and their peers. Speakers included Dr. Hans-Georg Wagner from the European Medicines Agency, Dr. Adam Aparicio from Merck, Mickel Hedemand from the DKMA, and Susanne Kienberger from Swissmedic.

"I thought the topics were well chosen and very relevant," said Alastair Nixon, Director of Submission Publishing for GlaxoSmithKline Research & Development. "All the sessions were engaging and the venue was exceptional. The whole event was excellent."

"An excellent event," stated Jaroslava Paraškevová, Head of Documentation & Information Service for Meda Pharma. "Probably the only one of its kind enabling an intensive exchange between industry and authorities."

"The feedback from attendees was extremely positive," stated Christian Bohrmann, Vice President of Global Sales and Marketing for EXTEDO. "All of the speakers did an outstanding job preparing for this year's event. The sessions provided attendees with insight into some of the key regulatory changes on the horizon, and numerous tips on how to successfully manage their submissions."

About EXTEDO

EXTEDO is the key solutions and services provider in the field of eRegulatory Affairs. The complete EXTEDOsuite is unique in all that it covers: Product Registration Planning & Tracking, Submission Management, Pharmacovigilance Management, Labelling Management, and Document Management.

EXTEDO provides configurable off-the-shelf products, as well as customized and integrated solutions. EXTEDO also provides EURS is Yours, the validation, review and approval system for the EMA and more than 25 Regulatory Authorities worldwide.

Today EXTEDO serves more than 700 customers in 57 countries ranging from small companies with less than 25 employees to large multi-national organizations. EXTEDO operates in the following markets for human, veterinary and crop protection: Life sciences, including pharmaceutical, biotech and biopharma, generics, homeopathics and medical devices, healthcare, and public sector. EXTEDO is recognized as the worldwide leader in each of its areas of operation.

For more information visit www.extedo.com

All trade names, trademarks, and service marks are the rightful property of their respective owners.


Media Contact:
Michael Kane
EXTEDO
Tel: 1-978-257-2179
Email Contact

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