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Volume 16 Issue 3
 
 
Orphan Drug Designations – Are the EMA and FDA looking for the same Information?
Editorial Archive

Orphan Drug Designations – Are the EMA and FDA looking for the same Information?

Whilst working on a recent European application for an Orphan Drug Designation (ODD) for a rare neurological condition that was being made to the EMA, I noticed that ...
15 June 2015 Editorial Archive | Regulatory V7 I3
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Common Pitfalls of RECIST 1.1 Application in Clinical Trials
Editorial Archive

Common Pitfalls of RECIST 1.1 Application in Clinical Trials

Revised Response Evaluation Criteria in Solid Tumours (RECIST 1.1) came into effect in 2009 in order to address the issues and limitations of RECIST 1.0. While RECIST...
15 June 2015 Editorial Archive | Regulatory V7 I3
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Supplier Qualification: A Review
Editorial Archive

Supplier Qualification: A Review

It is a GMP requirement to certify the vendor to deliver high quality and safe medicines, and to prevent recalls, deaths, adverse events, and serious illness due to s...
15 June 2015 Editorial Archive | Regulatory V7 I3
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Device Integration in Clinical Research – A Fad or the Future?
Editorial Archive

Device Integration in Clinical Research – A Fad or the Future?

Nowhere is the advance of technology felt more acutely than in the field of healthcare and clinical research. The very future of the industry relies on ever-more inte...
15 June 2015 Editorial Archive | Regulatory V7 I3
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