EXTEDO, a key eSubmission solutions provider for life sciences firms, today announced that they will be hosting the fourth annual OPENeCTD forum on September 28-29, 2009, in Nice, France.
The OPENeCTD forum is a must attend event for regulatory affairs professionals in the life sciences industry. Attendees will learn about the many key developments and the latest news around the eCTD standard and related eRegulatory developments by a distinguished panel of industry and authority experts.
"If you have not attended in the past, be prepared for an event that will set new standards -- with top-level speakers, up-to-date information and many networking opportunities," said Tore Bergsteiner, Managing Director for EXTEDO.
The following regulatory authority experts (alphabetical order) will be presenting the latest national and regional status information as well as upcoming requirements:
-- Caroline Auriche, Afssaps, FR -- Louis Boulay, HC, Canada -- Karin Gröndahl, MPA, Sweden -- Claire Holmes, EMEA, EU -- Dr. Stephan Järmann, Swissmedic, CH -- Yoshihiko Inazumi, PMDA, Japan -- Yasemin Karabey, TMH, Turkey -- Lidija Makarova, LSAM, Latvia -- Dr. Norman R. Schmuff, FDA, USA
Also presenting will be leading experts from btconsult, CanReg, Celgene, Comply Services, eCTDconsultancy, EXTEDO, Genzyme, GSK, Ipsen, Klever/Angelini, LSCP, Merck-Serono, MSD, PharmaLex, ProductLife Groupe, Qdossier, Roche, SAFE-Biopharma, SDL, SP-MSD
Topics will include:
-- The global eCTD: Submitting eCTDs to the FDA, HC and the EU -- Validation Requirements and how to adopt internal business processes -- Paper Publishing Requirements - Best Practices, Clinical Report and Study Publishing -- eCTD Collaboration between Companies - Interoperability of eCTDs -- Submission Planning and Tracking - How to manage registrations -- Hyperlinking - Requirements and Best Practices -- The Product Lifecycle Dossier - Considerations beyond a single application -- Global Labeling - Requirements & Best Practices -- Status of the EU regulations - Readiness of EU regulations (various countries) -- Worldwide electronic Submissions - The eCTD outside the ICH & Non ICH electronic Submissions -- Best Reviewing Practices of NeeS + eCTDs