SFL is pleased to announce that Shayesteh Furst-Ladani, SFL's Managing Director, has been invited to give a presentation on the classification and regulation of drug/device combinations at the MEDTEC Europe event to be held in Stuttgart, Germany.
Attracting 14,000 attendees annually and featuring key experts from industry, MEDTEC Europe has developed into a leading event for the medical technology sector.
During the session on Wednesday 27 February, Shayesteh will be giving a presentation entitled "Optimum classification, conformity assessment and regulatory route for drug/device combinations". In her talk, she will be giving clear guidance on the different types of combination products, the regulatory route for each classification and requirements to be fulfilled. Furthermore, she will outline proposed changes in the Medical Device Regulation impacting manufacturers of combination products.
"It is important that medtech companies monitor changes in requirements very closely and implement compliance measures timely" commented Shayesteh.
Shayesteh is the Managing Director and founder of SFL. She has comprehensive experience in formulating global regulatory strategies and provides support for the development of drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics and advanced therapy medicinal products.
Shayesteh is Chair of the Combination Products Topic Group at EuropaBio. She has been member of the Program Committee of DIA EuroMeeting for 2011, 2012 and 2013 leading the Theme Drugs, Devices, In Vitro Diagnostics and their Combinations and will present on the revised Directives for medical devices and in vitro diagnostics at the upcoming DIA EuroMeeting in Amsterdam
Shayesteh has recently published a number of articles about medical device regulation and related regulatory areas, which are available on the SFL website.
Shayesteh held several management positions within the pharma, biotech and medical device sectors before founding SFL. She was Head of Global Regulatory Affairs for Kuros Biosurgery, Global Regulatory Leader at F. Hoffmann-La Roche, and Head of Regulatory Affairs for Development Products at Baxter Bioscience, BioSurgery Unit. She received her MSc in Microbiology from the University of Vienna, Austria, and an MBA from the Open University Business School, Milton Keynes, UK.