Paolo Biffignandi https://www.epmmagazine.com/topics/paolo_biffignandi/index.rss en-gb © Rapid Life Sciences Ltd, a Rapid News Group Company. All Rights Reserved. Tue, 26 Nov 2013 11:47:00 -0000 Paolo Biffignandi 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. https://www.epmmagazine.com/blogs/regulatory-affairs-column/what-is-a-well-established-use-application/ https://www.epmmagazine.com/blogs/regulatory-affairs-column/what-is-a-well-established-use-application/ Tue, 26 Nov 2013 11:47:00 -0000 Reg Affairs Paolo Biffignandi Biosimilars sector from EU and US perspectives 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... https://www.epmmagazine.com/blogs/regulatory-affairs-column/biosimilars-sector-from-eu-and-us-perspectives/ https://www.epmmagazine.com/blogs/regulatory-affairs-column/biosimilars-sector-from-eu-and-us-perspectives/ Tue, 26 Mar 2013 12:10:00 -0000 General Paolo Biffignandi Asia's changing regulatory environment and pharma outsourcing 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... https://www.epmmagazine.com/blogs/regulatory-affairs-column/pharma-outsourcing-in-asia-and-the-changing-regulatory-environment/ https://www.epmmagazine.com/blogs/regulatory-affairs-column/pharma-outsourcing-in-asia-and-the-changing-regulatory-environment/ Mon, 14 Jan 2013 14:45:00 -0000 Regulatory Affairs Paolo Biffignandi Extractables, leachables and QbD Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... https://www.epmmagazine.com/blogs/regulatory-affairs-column/extractables-leachables-and-qbd/ https://www.epmmagazine.com/blogs/regulatory-affairs-column/extractables-leachables-and-qbd/ Tue, 20 Nov 2012 17:29:00 -0000 Extractable, Leachables & QbD