Dr. Paolo Biffignandi has a medical education from the Universities of Torino and also of Naples, Italy. He holds a PhD in Endocrinology and a second in Pharmacology. Dr. Biffignandi is Chief Medical Officer of EU Vigilance and Director of our Italian Office in Torino. At EU Vigilance he acts mainly as an EMEA-certified QPPV (Qualified Person in Pharmacovigilance). Dr. Biffignandi is also an expert in European Regulatory Affairs and he is Owner and CEO of VI.REL Pharma, Torino, Italy, since 1997.
He has more than 25 years of industry and consulting experience in clinical, medical and pharmaceutical affairs. Dr. Biffignandi has operated as Medical Director, Scientific Director and CEO in different companies in the pharmaceutical industry. Dr. Biffignandi's medical and pharmaceutical expertise and operational routine is complemented by a thorough understanding of EU pharmacovigilance system requirements. He has been an invited key speaker at several meetings, among these e.g. “Pricing & Reimbursement of Pharmaceuticals” meeting (Brussels, 2002) and the 5th “Annual Pharmacovigilance” meeting (London, 2010).
For many years he served as Board member of TOPRA (The Organisation for Professionals in Regulatory Affairs). He is Chairman of TOPRA Publishing and also was President of TOPRA in 2009-2011. He was member of The Editorial Panel of the journal “Regulatory Rapporteur”, since 2004. He also is Member of the International Society of Pharmacovigilance, since 2009.
Prof. Biffignandi chaired or co-chaired several regulatory meetings and symposia, e.g. Principle, TOPRA, Forum, EMA and Practices of EU Regulatory Affairs (RAPS, Brussels 2002); EU Pharmaceutical Legislation (Istanbul, 2005); Establishing Clinical Trials for GCP Compliance (Ankara, 2006); e-Working with the European Regulatory Agencies (Vienna, 2008) and Meeting with the EU Commission for a Pharmacovigilance session in Brussels, 2009.
He is the author of more than 160 scientific papers in Endocrinology, General Medicine, Diabetology, Pharmacology and Regulatory Affairs. You can find a selection in our Publications.
EU Vigilance