Archives: Speakers

Hadas Friedman serves as Pharma Two B’s VP QA, RA and Clinical Affairs since 2013. Prior to this served as the VP QA, RA and Clinical Affairs at Intec Pharma from 2004. Previous companies include Procognia and Rafa Laboratories. Completed a Bachelors of Science and a Masters of Science at the Bar-Ilan University.

Dr. Uri Heiman, Married with two teenage kids and a cat. Currently works for Laminate medical, Medical device startup as Clinical development Director responsible for training and establishing proper use of the devices the company provides, to support creation of innovative data and knowledge and to support further development of new devices. Previously have worked as a clinical specialist for local distributer in the field of cardiac surgery and ultrasound systems for cardiac use BSc. Biology, DVM Veterinary, Hebrew university MBA Tel Aviv university

Efrat Hartog-David, VP of Regulatory Affairs and Quality Assurance at MeMed has over a decade of experience in Quality Assurance, Clinical and Regulatory Affairs. She has managed product lifecycle quality and regulatory submissions for clearances of numerous medical devices in the US, EU, China, and rest of the world. Before joining MeMed, Efrat was Regulatory Affairs Manager at GE Healthcare, responsible for leading and executing the global regulatory strategy for the Nuclear Medicine business. As part of her role at GE Healthcare she led a team responsible for providing leadership and guidance on global compliance, developing global regulatory strategies and plans, and preparing regulatory submissions and worldwide registrations. Efrat has also served as Regulatory Affairs specialist at Philips Healthcare, where she was the regulatory lead for programs aimed at introduction of new product, and played a key role in internal and external audits. Prior to that, Efrat served as a consultant for a wide range of medical device companies, focusing on clinical study design, quality system management, and regulatory strategy development and execution. Efrat holds a B.Sc. and Ph.D. in Biotechnology and Food Engineering from the Technion, Haifa, Israel.

Mor Buchshtav, B.Sc., is the Director of Clinical & Regulatory Affairs at Medasense Biometrics Ltd. with over 12 years of experience in the medical device industry both from the clinical and the regulatory aspects. Mor is experienced with planning, executing, monitoring and analyzing bench tests, clinical studies and human factor studies, and has a record of successful regulatory submission of medical devices to Europe, United States, Canada, Brazil and various other jurisdictions. Her work is characterized by meticulous attention to details, dedication, drive to success and a love of the profession.

Hilla Debby Clinical Director at Icecure-Medical with over twenty years of experience in medical device industry. Her experience covers leading global clinical and regulatory activities. Holds a BsC in medical science.

After 3 years in a clinical field as a registered nurse and almost 15 years of various positions in the pharmaceutical and medical device industries, in 2019 Nina joined Neuroderm as a Global Training and Patient Education Manager, mainly responsible for managing global company clinical trials training program and managing global CTEs (Clinical Trial Educators) activities and training.

• Apprenticeship as chemical laboratory assistant at Bakelite AG, Germany
• Studies – M.Sc. degree in Bio- and Nanotechnology at the University of applied sciences South Westphalia, Germany
• Research work at the university – corrosion protection of offshore installations by coatings
• since 2014 at Bakelite GmbH in technical customer support & leading of the technical service team
• Direct technical support of phenolic resin applications in carbon products and composites & support of customer related projects
• Leading of the technical team responsible for other applications of phenolic resins such as refractories, friction, abrasives, textile nonwovens…