Companies across Europe have been realising the importance of a close
interaction between GMP and GCP in the organisation and initiation of sound and
appropriate clinical trials. A key element for a successful development of a
pharmaceutical product 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 the applicable rules and regulation is
mandatory. Both GMP and GCP requirements need to be considered and understood
from all parties involved - a fact that is often neglected.
For that reason the European Compliance Academy (ECA) offers a new education
course - "The Management of Clinical Trials - GMP meets GCP". It will cover all
essential aspects relative to the organisation and management of the supplies,
their distribution and things to consider during the study. It will also address
how the various regulations lead the way, and it will elaborate the important
interfaces between GMP and GCP.
This course is supported by two organisations - the Swiss Biotech Association
(SBA) and the International Federation of Associations of Pharmaceutical
The Swiss Biotech Association (SBA) is the industry association of small and
medium-sized enterprises in all areas of biotechnology, including
pharmaceuticals, diagnostics, agriculture, food, environmental biotechnology,
and specialty chemicals. Founded in March 1998, the Association now represents
more than 150 companies. http://www.swissbiotechassociation.ch/
The aim of the IFAPP is to act as an international forum for all the
organisations of Pharmaceutical Physicians world-wide. The IFAPP fosters the
development and international recognition of Pharmaceutical Medicine as a
medical specialty and the development of training and continuing education
programmes in pharmaceutical medicine. IFAPP counts 30 national Member
Associations (representing 6,500 individual members).