Third EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on Non-clinical Aspects'

• Date:
  maandag, 2 februari 2009, Hele dag
• Locatie:
  European Medicines Agency, Amsterdam, the Netherlands

On 2 February 2009, despite snow and adverse weather conditions in London, more than 100 representatives from micro, small or medium sized enterprises (SMEs) and their stakeholders participated in this SME workshop. The objective of the workshop was to provide an overview of non-clinical data requirements for authorisation of new medicinal products, highlighting key success factors and practical advice from an EU assessors' perspective. Topics covered included: safety pharmacology, requirements for first-in-human clinical trials, genotoxicity, reprotoxicity and carcinogenicity.

Documents

Agenda - Third EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs) 'Focus on non-clinical aspects'

Reference Number: EMEA/547748/2008

Global development challenges: Classical and advanced therapy medicinal products - Beatriz Silva Lima

Safety Pharmacology - Klaus Olejniczak

Requirements for the first In-Human clinical trials

General toxicity study designs - Jan Willem van der Laan

Meeting Requirements for EU Marketing Authorization: Genotoxicity and Carcinogenicity - Dr Peter Kasper

Meeting requirements for clinical trials and marketing authorisation reprotoxicity - Peter Kasper

Non-clinical documentation - Overview of Requirements - Jean-Marc Vidal

GLP Inspections in the Centralised Procedure - Brendan Cuddy

Recent experience in non-clinical assessment: Scientific advice and marketing authorization applications - Beatriz Silva Lima