April 04, 2013 -- SFL is pleased to announce that Shayesteh Fürst-Ladani, SFL’s Managing Director, has been invited to give a presentation at the Life Sciences College global conference, to be held in Brussels, Belgium from 17-18 April 2013.
In-depth training on key life sciences, legal and business issues is provided by an invited faculty of regulators, regulatory experts, academics as well as industry and private practice lawyers. During the morning session on Thursday, 18 April, Shayesteh will be giving a presentation entitled ‘Practical Considerations on Classification of Borderline Products’. Her presentation will cover areas such as the definition of borderline products, the institutional bodies in the EU/US providing advice on product classification and key scientific, regulatory and legal issues that companies must be mindful of. The emphasis will be on giving clear guidance to companies how to prepare for successful navigation in this complex field.
“It is imperative that companies ensure that they are proactive with respect to borderline products so that they adopt the right regulatory strategy,” commented Shayesteh.
“As well as speaking about the major developments in this fast changing area, I will be outlining practical approaches for an accurate classification of a borderline product and will present relevant case study.”
Shayesteh is the Managing Director and founder of SFL, a Swiss-based consultancy with expertise in Regulatory Affairs, Public Affairs, Legal Services and Medical Communication. She has comprehensive experience in formulating global regulatory strategies and provides support for the development of drugs, orphan drugs, drug and 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 the DIA EuroMeeting for 2011, 2012, 2013 and 2014 leading the Theme Drugs, Devices, In Vitro Diagnostics and their Combinations. In 2012, she received the Open University Business School’s Alumni Award Outstanding Contribution to an Organization.
About SFL Regulatory Affairs & Scientific Communication Ltd:
SFL is dedicated to a holistic approach to lifecycle management of healthcare products with expertise in Regulatory Affairs, Public Affairs, Legal Services and Medical Communication. At SFL we provide a personalized and integral oversight package for products from the bench to the marketplace at one consultancy. We provide clients with expert guidance on ethical aspects of lifecycle management issues, with consideration of the appropriate values, norms and principles ensuring consistent and coherent decisions are made. We provide also specialized training courses where participants can benefit from the team’s cross-functional expertise. We are proud of our broad knowledge and perspectives and strive to deliver services that meet the highest standards of professional performance.