Five years after the Clinical Trials Directive (CTD) came into force throughout the European Community, requiring Investigational Medicinal Products (IMPs) to be manufactured and assembled to standards of Good Manufacturing Practice (GMP) and formally released by a Qualified Person (QP), this symposium reviewed the experiences of the regulator, the industry and the end-user, as well as active QPs from pharmaceutical companies and an IMP outsource provider engaged in the provision of clinical supplies under the requirements of the CTD. The programme included contributions from the regulatory agencies, industry and academia, as well as an end-user at the sharp end, the customer in the clinic.

Final programme

PJ Report the regulator

PJ Report the trialist

PJ Report the industry

Full report

Speakers' slides