Mes compétences :
ECTD Manager
ICH Guidelines
Documentum
ISI Toolbox
EURS Validator
EZ Subs
Acrobat Pro
Lorenz Validator
Regulatory Guilines
Entreprises
Sanofi Pasteur
- Senior Regulatory Publisher
Lyon2004 - maintenantI have 10 years of publishing experience for basically all submission types
(AtoQ, clarifax, eIND, CTA, PIP, DSUR, Type IA IB II Variation , PSUR...) in Paper, Nees or Electronic submissions for Europe and 2 years of publishing experience for submissions to FDA and BGTB (US/Canada).
Publishing the Annual Strain Variation Northern Hemisphere and Southern Hemisphere (Vaxigrip) for 10 years.
Electonic submissions:
*Publishing with Extedo's eCTD Manager
*Validation with Eurs Validator (Europe)
*Validation with Lorenz (US/Canada)
Paper or Nees submissions:
*Expert Publisher with EZ Subs
*Expert using most Acrobat Plug-ins (ISI Toolbox)
*Expert using Documentum
