Marketing authorization procedures in eu
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SARQA/DKG Conference 3-4 October 2002 1 SARQA/DKG Conference 3-4 OCTOBER 2002 Annex 13 Update An Industry Perspective Michael J Cooke Director, Global.
Kiev, 04/12/2007 Analysis of EU MRP/DCP procedures regarding to generic applications Dr.Raimonds Lozda, FMS Baltic Ltd.
Advanced Therapy Regulation Hearing, Brussels May 11, 2006 Dr.Andreas Reimann CEO, Mukoviszidose e.V. (German Cystic Fibrosis Association) Vice-Chairman,
22nd May 2007 EURS Implementation Group Terms of Reference and Roadmap.
An agency of the European Union Summary of product characteristics (SmPC) What is it and what does it contain?
© WHO – PSM Validations –part 2 Workshop on GMP and Quality Assurance of TB products Kuala Lumpur Malaysia, 21 – 25 February 2005 Maija Hietava M.Sci.Pharm.
IRESSA Dr Rose McCormack Personalised Healthcare AstraZeneca A Presentation for the Translational Genomics Meeting Royal College of Physicians, London.
VTM Virtual Therapeutic Moeity Actual Therapeutic Moeity ATM VMP Virtual Medicinal Product AMP Actual Medicinal Product AMPP Actual Medicinal Product Package.
From POM to P From POM to P Wellard’s NHS training wellards.co.uk 2004.
Groupings: Several Type IA or IA IN affecting one MA One Type IA or change affecting several MAs from the same MAH Tightening of specification limits (change.
