08:00-08:30 | Welcoming |
08:30-08:45 | Clinical Trials Serving Medical Device Registration | Dr. Nadav Shefer
Manager, Medical Device Department, MOH |
08:45-09:15 | Clinical Trials in Medical Devices – The Role of the Regulator | Dr. Shlomo Yaacobi
Head of Clinical Trials in Medical Device and Advanced Therapies Unit, MOH |
09:15-09:45 | Work performed Locally (Israel)
היתרונות בעבודה כחול לבן | Dr. Naftali Meidan
Office of Deputy Director, Rabin MC
Director of Health Technologies& Assessment, Medical IT |
09:45-10:00 | Clinical Trial Data Management – Do & Don’t | Ms. Yael Shitrit
Clinical Data Management Dep. Manager, TechnoSTAT Ltd |
10:00-10:15 | Break |
10:15-10:30 | Medical Device Import to Israel | Dr. Nadav Sheffer
Manager, Medical Device Department, MOH |
10:30-11:00 | First in Human Medical Device Trials – Getting it Right | Dr. Miriam Ivenshitz
Clinical Research Manager, Kyma Medical Technologies |
11:00-11:30 | The King is Naked
המלך הוא עירום | Mr. Micha Oestereich
Clinical and Regulatory Affairs of Medical Devices |
11:30-12:00 | Break |
12:00-12:45 | The New EU Medical Device Regulation – The Clinical Requirements Section (Including Post Market Clinical Follow Up)
*This lecture will be given in English | Mr. Robert van Boxtel
Principle Consultant, MDProject, Netherlands
 |
12:45-13:15 | On The Way to New Regulation in Europe –
Updating the Guideline Document for Clinical Evaluation of MD MEDDEV. 2.7.1 Rev.4 | Dr. Shany Blum
VP, Head of Clinical Development Services, Physio-Logic Ltd. |
13:15-14:00 | Clinical Studies for 510(k)s and De Novos in the US, Regulatory Aspects
*This lecture will be given in English | Mr. Gerard Prud’homme
Partner, Hogan Lovells US LLP, USA  |
