Clinical Development

Changes to EU clinical trial laws will mean fairer playing field, says Clinipace

21-Aug-2012
Last updated on 21-Aug-2012 at 13:06 GMT - By Natalie Morrison
Interview of Andrea Schiefer - VP of European clinical operations and executive director of pharmacovigilance, Clinipace
Changes to EU clinical trial laws will mean fairer playing field, says Clinipace
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The proposed changes to European clinical trial regulations accepted by the European Commission (EC) in July will put Europe on an equal playing field, according to Clinipace’s Andrea Schiefer.

Speaking to Outsourcing-Pharma.com, the firm's VP of European clinical operations and executive director of pharmacovigilance said the directive will correct the mistakes of the past that have caused a reduction of clinical trials in Europe.

When asked if it is ethical to make one market very attractive for conducting trials, she said: “I don’t think it will lead to a great influx in trials. It will be a slow development and it will make it more proportionate and more fair compared to the situation now.”

Schiefer added that if anything, the EC could have implemented more scientific expert committees looking at certain indications when forming the new guidelines.

Related topics: Clinical evolution, Clinical Development, Phase I-II, Regulatory affairs