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CTLSIE 
The Race for the Development of Drugs 
and Medical Devices - Innovations 
and Global Trends 
Conference Content 
Manager: 
December 11, 2014 David Intercontinental Hotel, Tel- Aviv 
Online Registration 
This Conference is held within L S I E 2 0 1 4 Life Science Industry Event 
MDDMILSIE ManageMedLSIE Exhibition & Conferences ITTNLSIE 
December 10-11, 2014, David Intercontinental Hotel, Tel- Aviv 
LSIE In Collaboration with: MDDMI 
Further Information regarding exhibiting or sponsorship opportunities, please contact: 
Anat Weiss-Ronen, Tel: 03-5626090 ext. #3, 054-4504045, anatw@stier-group.com 
www.lsie.co.il 
*The program is subject to changes. 
08:00-09:00 Registration and Reception 
09:00-09:05 Opening Remarks 
Ahuva Koren, President & CEO, GCP Clinical Studies Ltd., Conference content manager 
09:05-09:15 Ministry of Health - Welcome Greetings 
Liron Zohar, Coordinator, Health Services Basket Committee, Israeli MOH 
09:15-09:50 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 pitfalls 
Moshe (Michael) Kasser, Regulatory Specialist, Hogan Lovells Israel Ltd. 
10:25-11:00 Successful Collaboration with the FDA throughout the drug development process 
Techiya Toaff, Consultant, prior FDA Project Manager 
11:00-11:20 Coffee Break 
11:20-11:55 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 Devices 
12:30-13:15 Lunch Break 
13:15-14:00 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 TBA 
14:45-15:00 Coffee Break 
15:00-15:30 2014 Guidelines for Clinical Trials in Human Subjects - implementation update 
Dr. Mina Arinos, Clinical Trials Department Manager, Israeli MOH 
15:30-16:00 Panel Discussion 
CT Sponsors: 
Life Science Industry Event LSIE2014 
LSIE Sponsors: 
Media Partners: 
Exhibitors (updated 5.11.14):

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Lsie2014 ct

  • 1. CTLSIE The Race for the Development of Drugs and Medical Devices - Innovations and Global Trends Conference Content Manager: December 11, 2014 David Intercontinental Hotel, Tel- Aviv Online Registration This Conference is held within L S I E 2 0 1 4 Life Science Industry Event MDDMILSIE ManageMedLSIE Exhibition & Conferences ITTNLSIE December 10-11, 2014, David Intercontinental Hotel, Tel- Aviv LSIE In Collaboration with: MDDMI Further Information regarding exhibiting or sponsorship opportunities, please contact: Anat Weiss-Ronen, Tel: 03-5626090 ext. #3, 054-4504045, anatw@stier-group.com www.lsie.co.il *The program is subject to changes. 08:00-09:00 Registration and Reception 09:00-09:05 Opening Remarks Ahuva Koren, President & CEO, GCP Clinical Studies Ltd., Conference content manager 09:05-09:15 Ministry of Health - Welcome Greetings Liron Zohar, Coordinator, Health Services Basket Committee, Israeli MOH 09:15-09:50 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 pitfalls Moshe (Michael) Kasser, Regulatory Specialist, Hogan Lovells Israel Ltd. 10:25-11:00 Successful Collaboration with the FDA throughout the drug development process Techiya Toaff, Consultant, prior FDA Project Manager 11:00-11:20 Coffee Break 11:20-11:55 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 Devices 12:30-13:15 Lunch Break 13:15-14:00 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 TBA 14:45-15:00 Coffee Break 15:00-15:30 2014 Guidelines for Clinical Trials in Human Subjects - implementation update Dr. Mina Arinos, Clinical Trials Department Manager, Israeli MOH 15:30-16:00 Panel Discussion CT Sponsors: Life Science Industry Event LSIE2014 LSIE Sponsors: Media Partners: Exhibitors (updated 5.11.14):