Regulatory Affairs Blog

Eight years of DCP

When the decentralised procedure (DCP) was implemented in 2005, I was employed by an agency. It was a time of great change in the EU directive and a sense of anticipation accompanied its introduction. Previous to this, there were only two... more »

May 15, 2014 Regulatory Affairs Blog

Harmonisation challenges in the EU

The EU directive, as updated in 2005, had many objectives and one of them was to ensure that the agencies harmonised medicines from one county to another. Harmonisation can be seen in several ways but is for the most part divided into two main... more »

Apr 22, 2014 Regulatory Affairs Blog

The biopharmaceutical classification system — is it accepted?

The Biopharmaceutical Classification System (BCS), introduced in 1995, provides a framework for classifying the drug substance based on its aqueous solubility and intestinal permeability. It allows for the prediction of in-vivo pharmacokinetics of... more »

Jan 31, 2014 Regulatory Affairs Blog

About this Blog

Paolo is an advisory board member of the pan-European pharmaceutical regulatory affairs organisation ELC Group and EPM's Regulatory Affairs columnist. Dr. Biffignandi is a renowned physician who graduated in Medicine with PhDs in Endocrinology and Pharmacology. He began his highly successful career in the pharmaceutical industry after a period at the University of Torino, Italy, and in 1989 became an independent consultant in medical and regulatory affairs. He is the author of more than 160 scientific articles, co-author of three books on European Regulatory Affairs and a member of several scientific societies, including DIA, RAPS and TOPRA. From 2003, he was a member of the Board of Directors of TOPRA, of which he was President in 2009–10. In 2009, he was appointed Fellow of The Royal Society of Medicine in the UK.

Feedback? Suggestions? They are always appreciated. Feel free to contact us: Dr. Paolo Biffignandi

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