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The Trials and Tribulations of Importing Clinical Trials Materials into Europe

There are a number of key areas that international pharmaceutical companies will need to consider when planning to conduct clinical studies in Europe. Perhaps most importantly, companies need to be aware of several forthcoming regulatory changes, which will be implemented in the next three years as a result of the adoption of the Clinical Trial Directive (2001/20/EC of the European Parliament and of the Council).

Currently, there is no unified regulation governing the import and movement of material around Europe. Local country regulations apply, which in some countries can be as simple as a notification, while in others a formal application is needed. In the UK, for example, all the details of the study materials would be included in the CTX application.

In general terms, the manufacture of clinical materials is not presently required to comply with GMP, but there are some notable exceptions - Germany, for instance, which applies the same GMP to clinical trial materials (CTM) as to a marketed product.


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By Keren Winmill, Director of Clinical Trial Supplies at Penn Pharmaceutical Services

Keren Winmill is a Pharmacist with 24 years of experience in the pharmaceutical industry. She joined Penn Pharmaceutical Services in 1990 to manage the clinical supplies unit. Keren spent 12 years with Ciba Geigy in Switzerland and in the UK in regulatory affairs, business development and marketing positions.

Keren subsequently joined Quintiles as Director of Business Development, returning to Penn in 1999 as Director of the Clinical Supplies Business Unit. She is responsible for clinical trial packaging and supply management.

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