GMP meets GCP
Management, Supply and Quality Assurance of Clinical Trials

Berlin, Germany, 10-12 November 2010

Objectives:

During this conference, well-experienced specialists will share their expert knowledge
about important aspects of IMP Supplies and the Management of Clinical Trials. Hear essential
aspects about the organisation and management of the supplies, their distribution, things
to consider during the study and learn how the various regulations lead the way. During
this course, the important interfaces between GMP and GCP will be elaborated.

Background:

In the development of new pharmaceutical products, it is a challenge to design and initiate
sound and appropriate studies. Compliance with GMP and GCP regulations is mandatory.
A prerequisite for a successful study is the thorough planning of the clinical trial supplies.
Beginning with the order, the manufacturing and supply of the IMPs, an efficient study management
and full compliance with applicable rules and regulation lead to satisfactory results.
An area where requirements of both GMP and GCP requirements need to be considered
and understood from all parties involved. A fact which is often not the case.

Trials outside the EU and suspected misconduct and fraud are two other aspects which require
particular attention.

This event has been designed by the ECA to enhance and broaden your knowledge and to
consolidate the various aspects which need to be taken into account for an efficient management
of clinical trials.

Target Audience:

The conference is set up for specialists, managers and executives from R&D dealing with the
various aspects of IMP supply and clinical trial management. It addresses representatives
from IMP manufacturing, packaging and supply as well as from the study design and management
and the respective Quality Assurance Units. It is also directed to CROs and members of
inspectorates and authorities.