Fifth EMA workshop for SMEs "Regulatory considerations in initiating clinical trials"

• Date:
  Vendredi, 28 mai 2010, Journée Entière
• Lieu:
  European Medicines Agency, Amsterdam, the Netherlands

On 28 May 2010, more than 150 representatives from SMEs and their stakeholders participated in this SME workshop. This workshop was prepared in cooperation with the Clinical Trials Facilitation Group (CTFG). Regulators and SME representatives made presentations and participated in the discussion panels. Topics included an overview of the clinical trial authorisation framework in the EU, information on data requirements for initiating clinical trials, authorities' perspectives and regulatory requirements for initial clinical trial applications.

Documents

Agenda - Fifth training workshop SMEs

Draft Reference Number: EMA/770537/2009

Clinical trials in Europe - Introductory remarks, Dr Chantal Bà©lorgey

An overview of the clinical trial authorisation framework in Europe, Dr Chantal Bà©lorgey

The ethical review process: perspectives from an Ethics Committee, David Neal

Common elements of the CTA review process in National Competent Authorities, Dr Ingrid Wallenbeck

The voluntary harmonisation procedure (VHP) for the assessment of multinational clinical trial applications, Dr Hartmut Krafft

Quality documentation for investigational medicinal products, Dr Elaine Godfrey

Preclinical requirements, Dr David Jones

Initial clinical trial protocol design considerations, Dr Walter Janssens

Experience from an SME in initiating clinical trials, Dr Tom Vanthienen

GMP requirements, Dr Walter Janssens

GCP compliance, Dr Katalina Mettke

Safety monitoring and reporting, Dr Ingrid Wallenbeck