Press release
SFL’s Managing Director Invited to Speak at MEDTEC Europe Event in Stuttgart, Germany
SFL is pleased to announce that Shayesteh Fürst-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 from 26 to 28 February 2013. 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 Publication section of the SFL website.
SFL is dedicated to a holistic approach to lifecycle management of healthcare products from nonclinical and clinical studies through to registration and post-approval activities. The SFL team members have experience in Regulatory Affairs, Public Affairs, Legal Services and Medical Communications, and provide personalized and comprehensive services. When combined, these services comprise an integral oversight package for products from the bench to the marketplace at one consultancy. SFL also provides specialized training courses where participants can benefit from the team’s cross-functional expertise.
Faiz Kermani, PhD
Senior Communication Manager
SFL Regulatory Affairs & Scientific Communication Ltd
Hochstrasse 51,
CH-4002 Basel,
Switzerland
Tel: +41 61 361 9443
Fax: +41 61 361 9442
Email: office@sfl-services.com
Web: www.sfl-services.com
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