The Forum wishes to create in Italy an annual meeting of European Regulatory Affairs experts and pharma professionals to share experiences and last updates on current issues, regulatory changes, strategies and new trends in the Regulatory Affairs European landscape. An important aim of this conference is to offer networking opportunities and promote debate among European Regulatory Affairs delegates.



The involvement of European Regulatory Affairs experts, opinions leaders, regulatory body representatives, new IT technologies suppliers and consultants from Italy and Europe, makes this event highly appreciated by Pharma, Biotech, Medical Devices companies and also by the IT Suppliers, for the great opportunity to meet professionals and get and share technical knowledge and strategies about the future of the Regulatory Affairs in Europe.

The Congress will offer several sessions about hot topics, case studies, including round-table on:
• The European Regulatory Affairs landscape: changes, impacts of new Regulations and regulatory trends of new therapeutic products
• Regulatory Information Management: experiences and challenges
• Getting ready for novel data and approaches that will challenge regulatory decision-making
• Extra EU registration: challenges & strategies


• Regulatory Affairs VP, Directors, Manager, Head of Pharma, Biotech and Medical Devices Industries
• Regulatory Bodies
• Technology IT Suppliers

Via Dei Pratoni, 16 - 50018 Scandicci (FI)
Tel. (+39) 055 7227007 - 055 7224076 - 055 7224179