OPENeCTD forum
Hotel Le Méridien Nice, France
28 - 29 September 2009
DON’T MISS THIS EVENT !!!
PROGRESSING THE eCTD STANDARD AND BEYOND
As one of the leading conferences and in-depth knowledge exchange platforms, we cordially invite you to join us in Nice in September 2009 to benefit from a wealth of expertise and knowledge offered by selected experts. Give your business the perfect head start with targeted information on the eCTD and associated electronic registration management and submission processes.
Participants may expect an event that will set new standards – with top-level speakers, on-the-pulse information, and fascinating topics. Speakers like
- Daisy Aguilera, Celgene
- Dr. Adam Aparicio, Merck Serono
- Caroline Auriche, Afssaps
- Ruedi F. Blattmann, LSCP
- Luigi Fabbro, KLever
- Richard Furr, SAFE-Biopharma
- Mathias Ganz, Ipsen
- Maria Angela Gatto, Angelini Group
- Dr. Erick Gaussens, ProductLife Groupe
- Stephan Grande, Optimal Systems
- Karin Gröndahl, MPA Sweden
- Ted Hanebach, CanReg
- Therese Harris, Open Text
- Matthias Heyn, SDL
- Dr. Stefan Hock, btconsult
- Claire Holmes, EMEA, UK
- Yoshihiko Inazumi, PMDA, Japan
- Dr. Stephan Järmann, Swissmedic
- Anne-Thérèse de Jamblinne, Merck Sharp & Dohme, and Anaïs Renard, sanofi pasteur MSD SNC
- Yasemin Karabey, Turkish Ministry of Health
- Raun Kupiec, Genzyme
- Karl-Heinz Loebel, PharmaLex
- Lidija Makarova, Latvian State Agency of Medicines
- Dr. Andrew Marr, GSK
- Harv Martens, EXTEDO
- Alastair J. Nixon, GSK (EFPIA)
- Anne Mieke Reijnders, eCTDconsultancy
- Patricia Santos-Serrao, QUMAS
- Dr. Norman R. Schmuff, FDA, USA
- Rainer Schwarz, NextDocs
- Katrin Spaepen, Comply Services
- Michiel Stam, Qdossier B.V.
- Geoff Williams, Roche
- Kevin Wing, eCTDconsultancy
(in alphabetical order) have confirmed so far to present a distinguished view on the topics.
Sponsors confirmed: Open Text - NextDocs, Optimal Systems, QUMAS - ProductLife Groupe
The program is based on in-depth sessions covering a wide range of electronic drug approval standards and processes. Each selected session will present real-life scenarios, provide answers on challenging questions and new product developments, delivered by experts, who will share with you how they achieved success, solved problems and gained value. Presentations will be delivered by executives from authority, industry, eCTD consultancies, solution providers as well as EXTEDO experts.
Prepare yourself for two interesting days packed with presentations, case studies etc. as well as a delightful evening event in Nice on the 28th. Get to know the latest trends and innovative eCTD solutions, discuss the issues that matter to your business, swap experience and information with international experts from various engaged backgrounds. Just don’t forget to register…