Download pdf - CT LSIE - המרוץ לפיתוח תרופות ומכשור רפואי - חידושים ומגמות גלובאליות

CTLSIE

*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 & Conferences

LSIE2014This Conference is held within Life Science Industry Event

December 10-11, 2014, David Intercontinental Hotel, Tel- Aviv

Conference ContentManager:

The Race for the Development of Drugsand Medical Devices - Innovations

and Global Trends

CT Sponsors:

Further Information regarding exhibiting or sponsorship opportunities, please contact:Anat Weiss-Ronen, Tel: 03-5626090 ext. #3, 054-4504045, [email protected]

www.lsie.co.il

Online Registration

December 11, 2014 David Intercontinental Hotel, Tel- Aviv

Exhibitors (updated 1.9.14):

Sponsors:

https://www.tixwise.co.il/he/ctconf