CT LSIE 2014 המרוץ לפיתוח תרופות ומכשור רפואי - חידושים ומגמות גלובאליות 11 בדצמבר, 2014 מלון דיוויד אינטרקונטיננטל, תל- אביב להרשמה http://lnkd.in/dBYtbNC

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):