SFLâ€™s Managing Director provides regulatory insight into Drug Device Combination Products in Europe
Online PR News – 11-November-2013 – Basel, Switzerland – SFL is pleased to announce that Shayesteh FĂĽrst-Ladani, Managing Director of the company, will be giving a presentation at Informaâ€™s 8th Annual Drug Device Combination Products event, which will be held on 19-20 November in Berlin. The event will cover regulatory updates, real life examples and strategic advice for successful approval of device-drug and drug-device combination products globally.
During the afternoon session on Wednesday 20 November, Ms. FĂĽrst-Ladani will give a presentation entitled â€śOverview of current and future clinical data requirements for combination products.â€ť In her wide-ranging presentation, she will outline the clinical strategies suitable to support combination products applications, examine the current requirements and discuss proposed changes in the revision of the Medical Devices Directives.
â€śThe classification of a product has a huge impact on its clinical development, the regulatory pathway, costs and timelines for companies,â€ť she remarked. â€śSince different rules apply for clinical investigations regarding drug and device combinations, it is imperative that companies apply the appropriate strategy and seek expert advice.â€ť
Ms. FĂĽrst-Ladani 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 and device combination products, borderline products, medical devices, in vitro diagnostics and advanced therapy medicinal products.
She is Chair of the Combination Products Topic Group at EuropaBio. She has been member of the Program Committee of DIA EuroMeetings 2011, 2012, 2013 and 2014 leading the Theme Drugs, Devices, In Vitro Diagnostics and their Combinations. In 2012, she received the Open University Business Schoolâ€™s Alumni Award Outstanding â€śContribution to an Organizationâ€ť.
About SFL regulatory affairs & Scientific Communication:
SFL provides integrated solutions from the bench to approval and reimbursement within one consultancy, with expertise in Regulatory Affairs, public affairs, Legal Services, medical communication, HTA, Pricing and Reimbursement. SFL offers a personalized and integral oversight package. In our deliveries, SFL also considers ethical aspects of appropriate values, norms and principles. SFL conducts portfolio analyses and provide strategic support for products in diverse therapeutic areas. The SFL team works from offices in Switzerland and the United Kingdom, Europeâ€™s key locations for healthcare products development.