*The program is subject to changes.
08:00-09:00 Registration and Reception09:00-09:05 Opening Remarks
Ahuva Koren, President & CEO, GCP Clinical Studies Ltd., Conference content manager09:05-09:15 Ministry of Health - Welcome Greetings
Liron Zohar, Coordinator, Health Services Basket Committee, Israeli MOH09:15-09:50 The Cluster Approach, a Solution to Increasing R&D Productivity and Innovation
Suzana Nahum Zilberberg, CEO, Bio-Light Life Sciences Investments Ltd.09:50-10:25 Types of CDRH Premarket Submissions: when each type should be used and how
to avoid common pitfallsMoshe (Michael) Kasser, Regulatory Specialist, Hogan Lovells Israel Ltd.
10:25-11:00 Successful Collaboration with the FDA throughout the drug development processTechiya Toaff, Consultant, prior FDA Project Manager
11:00-11:20 Coffee Break11:20-11:55 The Medical device industry- what to consider when approaching the EU regulator?
Dorit Winitz, VP Clinical & Regulatory Affairs , Medial Cancer Screening Ltd.11:55-12:30 The challenges associated with your clinical planning - were the right decisions made?
Tami Abudi, Consultant, prior Clinical VP, Medical Devices12:30-13:15 Lunch Break13:15-14:00 Risk- Based Monitoring; Not Necessarily All or Nothing
Guest speaker: Becky (Causey) Carpenter, Vice President, Operations Management,Research Point Global, Austin Texas, USA
14:00-14:45 TBA14:45-15:00 Coffee Break15:00-15:30 2014 Guidelines for Clinical Trials in Human Subjects - implementation update
Dr. Mina Arinos, Clinical Trials Department Manager, Israeli MOH15:30-16:00 Panel Discussion
ManageMedLSIEMDDMILSIEITTNLSIEExhibition & ConferencesLSIE2014This Conference is held within Life Science Industry Event
December 10-11, 2014, David Intercontinental Hotel, Tel- Aviv
The Race for theDevelopment of Drugsand Medical Devices - Innovations
and Global Trends
Further Information regarding exhibiting or sponsorship opportunities, please contact:Anat Weiss-Ronen, Tel: 03-5626090 ext. #3, 054-4504045, email@example.com
December 11, 2014 David Intercontinental Hotel, Tel- Aviv
Exhibitors (updated 1.9.14):