Second EMEA Workshop for Micro, Small and Medium-Sized Enterprises (SMEs), 'Focus on Quality'

• Date:
  Saturday, 9 February 2008, All day
• Location:
  European Medicines Agency, Amsterdam, the Netherlands

On 8 February 2008, more than 140 representatives from micro, small or medium sized enterprises (SMEs) and their stakeholders participated in this SME workshop, the second of its kind held at the EMEA. The objective of the workshop was to provide an overview of data requirements for authorisation of new chemical entities and biologicals, highlighting key success factors and practical advice from an EU assessors' perspective. Presentations also included highlights from recent scientific advice and protocol assistance, GMP compliance, 'Quality by Design' and the Regulation of Advanced Therapies.

Documents

Agenda - Second EMEA workshop for Micro, Small and Medium-Sized Enterprises (SMEs) 'Focus on Quality'

Draft Reference Number: EMEA/331656/2007

Update from 'SME Office' for micro, small & medium-sized enterprises - Melanie Carr

Scientific Advice on Quality Aspects for Biologicals - Jean-Hugues Trouvin

The Common Technical Document- Quality (CTD-Q) - George Wade

GxP Inspections within the centralised procedure - Brendan Cuddy

Overview of applications for mMarketing authorisation - Recent experience in quality assessment - Dr Cornelia Nopitsch-Mai

Key considerations for a new chemical entity (NCE) - Ryan Tomlinson

Recent experience in quality assessment - Sol Ruiz

Key considerations for a biological product - K. Ho

EMEA SME workshop biological GMP issues - Ian Rees

Quality by Design - Application and perspectives for biologicals - Evdokia Korakianiti

Quality by Design - Process analytical technology and risk-based CMC development - Kowid Ho

The Regulation on advanced therapies - Nicolas Rossignol

The EMEA innovation task force - Constantinos Ziogas