Basel, Switzerland, September 01, 2013 --(PR.com
)-- SFL’s Managing Director and Founder, Shayesteh Fürst-Ladani has been invited to speak at the World Medtech Forum’s Event “Pharma meets Medtech” to be held in Lucerne, Switzerland on 18 September.
Ms. Fürst-Ladani and 3 other key note speakers will share their views how the pharma and medtech sector can improve collaboration for the development of combination products. The event will feature presentations on the major technological and regulatory trends that are influencing the field. As a recognized authority on international regulatory affairs, Ms. Fürst-Ladani will be giving a presentation entitled "Legislative influence on the pharma and medtech industry."
“The development of combination healthcare products is inevitably a complex process, as it brings together two sectors with quite distinct sets of knowledge and culture,” commented Shayesteh. “Regarding the development of combination products, multiple regulatory frameworks may be applicable. For collaborative ventures to succeed, the pharma sector needs a better understanding of the medical device rules and the medtech sector has to acknowledge drug regulations.”
Shayesteh has longstanding experience in formulating global regulatory strategy for drugs, orphan drugs, drug & device combination products, borderline products, medical devices, in vitro diagnostics (IVDs) and advanced therapy medicinal products (ATMPs). She has been involved in reviewing and assessing the impact of European and US legislation, such as the Cell & Tissue Directive, the Advanced Therapy Medicinal Products Regulation, and the Orphan Medicinal Product Regulation, and reviewing requirements impacting Drug & Device Combination Products, Personalized Medicine and HTA.
Shayesteh held several management positions within the pharma, biotech and medical device sectors before founding the consultancy company SFL Regulatory Affairs & Scientific Communication. She received her MSc in Microbiology from the University of Vienna, Austria, and an MBA from the Open University Business School, Milton Keynes, UK. She is an active member of EuropaBio and DIA. Shayesteh is Adjunct Professor for Regulatory Affairs at the George Washington University School of Medicines and Health Sciences.