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In order to ensure that APIs meet the requirements for quality and purity that they purport or are represented to possess, the Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients (Q7) was developed by the International... more »
Apr 29, 2013 in Regulatory Affairs Blog
Biosimilar medicines, one of the fastest growing sectors of the industry, constitute a major share of pharmaceutical expenditure in the EU, the US and globally. From a regulatory perspective, they are a new paradigm in drug development, similarly... more »
Mar 26, 2013 by Paolo Biffignandi in Regulatory Affairs Blog
Asia is the fastest growing pharmaceutical market in the world, providing significant opportunities for drug development and marketing. Consequently, pharmaceutical regulations in this region are fast gaining attention... more »
Jan 14, 2013 by Paolo Biffignandi in Regulatory Affairs 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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