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 in Regulatory Affairs Blog

What Is a Well-Established Use Application and When Can it be Used?

The legal basis of the application has a profound impact on the extent and nature of the data provided in the dossier and it is therefore of critical regulatory importance. more »

Nov 26, 2013 by in Regulatory Affairs Blog

Overview of the EMA’s ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form’

On 4 July 2013, the European Medicines Agency (EMA) published the ‘Draft concept paper on the need for revision of the note for guidance on manufacture of the finished dosage form (EMA/CHMP/QWP/324350/2013)’ for consultation. more »

Oct 16, 2013 in 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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