News

[28-08-2006] : Draft Guidance for Good Clinical Practice in EU

DG Enterprise and Industry releases ‘Draft guidance on ‘specific modalities’ for non-commercial clinical trials referred to in Commission Directive 2005/28/EC laying down the principles and detailed guidelines for good clinical practice’.

This guidance includes information regarding the definition of non commercial clinical trial and the specific modalities, labelling and documentation, concerning the investigational medicinal product. DG Enterprise and Industry has also been considering the issue of the monitoring of non-commercial clinical trials.

However, specific modalities on monitoring have not been included in this draft guidance since they would go beyond the provisions of Directive 2005/28/EC. Nevertheless, if stakeholders want to make comments or proposals in relation to the monitoring of non-commercial clinical trials, they are welcome to do so in the framework of this consultation.

We invite comments on the draft proposal to be sent to birka.lehmann@ec.europa.eu and rui.santos-ivo@ec.europa.eu until 1 October 2006.

The Story behind our Logo

The eye of Horus literally means ‘healed’ or ‘healthy’ eye and it is said to have regenerative powers. SPMC has chosen to emblaze this logo as it’s reflects our aim to always have a healthy eye on our clients affairs

The Anatomy Lesson of Dr. Nicolaes Tulp by Rembrandt van Rijn, dated 1632.

This painting shows the dissection of the corpse of criminal Aris Kindt, hanged earlier that day for armed robbery by Dr. Nicolaes Tulp in front of medical students from the University of Leiden. Both SPMC and Rembrandt saw the light of day in Leiden and share a common value in their work: eye for detail. SPMC has strong ties with the University of Leiden and is located near the Universiy and the Bio-Science park.