"Science Behind the Best Health"

Dr. Ken Caldicott

Ken Caldicott has thirty years experience in the pharmaceutical industry having started his career in the QC labs of Parke-Davis/ Warner- Lambert. He then progressed through several analytical and QA roles within the Research Division of the Company.

In 1993 Ken joined Penn to set up the analytical development department and later also took responsibility for formulation development. His current role as Chief Scientific Officer is free ranging and is mainly concerned with providing consultancy advice for the development/ regulatory interface and with matters relating to GMP particularly to Penn's Japanese and US clients.

Ken has a PhD in analytical chemistry, is a Fellow of the Royal Society of Chemistry and a registered Qualified Person.

The presentation will discuss the background to the directive and the major changes affecting the production of investigational medicinal products. It will explain what a Qualified Person is and what he/she must do. Particular attention will be paid to the issues faced by non EU companies importing IMPs into the EU.

Guidance will be offered as to the differences in GMP requirements for IMP versus commercial products. Options for supply of IMP will be suggested together with flow charts designed to make the process as efficient as possible.

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