Date
- Tuesday, 24 February 2009, All day
Location
- European Medicines Agency, Amsterdam, the Netherlands
Documents
Agenda - EMEA - EFPIA info - day
English (EN) (98.34 KB - PDF)
EMEA Performance Indicators pre-authorisation - Bo Aronsson
English (EN) (681.55 KB - PDF)
Presentation and Analysis of the EFPIA questionnaire 06/08 on the centralised procedure new applications David Jefferys - Eisai
English (EN) (333.27 KB - PDF)
EMEA Performance Indicators - Extensions of indications - Manuel Haas
English (EN) (430.83 KB - PDF)
EFPIA Performance Indicators: extension of indications 2007-2008 Elisabeth Vromans - Schering-Plough
English (EN) (252.76 KB - PDF)
CHMP work programme: Practical aspects
English (EN) (464.36 KB - PDF)
EFPIA position on CHMP work programme: Evaluation of risk benefit - Scientific Advisory Groups
English (EN) (95.44 KB - PDF)
The EMEA policy on invented names Zaide Frias - EMEA - Chair of Name Review Group
English (EN) (17.07 MB - PDF)
Implications of the EMEA Naming Policy - An industry perspective Anja Manz - Novartis
English (EN) (190.68 KB - PDF)
Compliance check & Validation of applications with an agreed PIP Thorsten Olski
English (EN) (521.06 KB - PDF)
Compliance check & Validation of applications with an agreed PIP Ali Harrison - AstraZeneca
English (EN) (358.24 KB - PDF)
Continuous dialogue from product development throughout product lifecycle Tomas Salmonson - Vice Chair CHMP
English (EN) (1.93 MB - PDF)
Continuous dialogue from product development throughout product lifecycle Andre Broekmans - Schering-Plough
English (EN) (671.52 KB - PDF)
eCTD/Non eCTD electronic Submission (Nees): Impact on the centralised procedure Claire Holmes
English (EN) (113.22 KB - PDF)
eCTD/Nees impact on the centralised procedure Goeffrey Williams - Roche
English (EN) (352.15 KB - PDF)