Q&A Regulatory Series for Israeli Medtech
Manufacturers Entering New Global Markets in 2021
PRESENTED BY ARAZY GROUP CONSULTANTS INC.
SERIES 1

14:00 Tuesday,  January 5:
Eurasia 
EAEU, Kazakhstan, Russia & Ukraine 
 
14:00 Tuesday, January 26:
Latin America
Argentina, Brazil, Colombia, Ecuador & Peru
 
14:00 Tuesday, February 16:
Southeast Asia
Singapore, South Korea, Taiwan & Thailand 
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ABOUT THE EVENT
REGtalks is an informative series with a focus on answering your specific regulatory questions in each dedicated market. Our aim is to provide knowledge that will assist you with your regulatory journey into new markets for 2021.
This series will be held in English.
MARKET- ACCESS INFORMATION
Each session will provide an overview of the regulatory landscape in the specific markets.  We will cover information on the registration process, local testing requirements, classification, timeframes and more for each of these unique markets.  
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EXPERT Q&A SESSION
Have your specific questions answered by regulatory professionals in each market. You will have a chance to submit all of your questions beforehand to be answered during the session by our experienced, local experts.  
REGULATORY TECHNOLOGY
This series will showcase how to use advanced technology for project registration activities such as an intial registrations and renewals in the selected markets. It wil also explain how to take advantage of the market's compliance requirements in order to enter further countries. 
SPEAKERS
Host
Yoav Madai
Business Development & Account Manager
Arazy Group Consultants
Yoav Madai is a Business Development and Account Manager at Arazy Group Consultants and has spent the last year and a half developing new territories with a focus on the Israeli medtech market. In this role, Yoav also supports East Asian companies with their journey to enter their medical and IVD devices into new markets. Yoav had worked closely with many companies world-wide, from incubator companies to large scale manufacturers. Prior to Arazy Group, Yoav was working as an International Sales Manager in China. 
Expert Panel
Carlina León (Latin America)
 
Carlina has over four years of regulatory affairs experience and has worked as a Project Manager at Arazy Group since 2019 where she worked on more than 150 medical and IVD device regulatory projects. Carlina has extensive experience leading teams to new markets and resolving requirements from the competent authorities in Latin America.  Prior to Arazy Group, Carlina has worked in regulatory for BD and Fresenius Medical Care as well as completed her Biomed Engineering degree at the National University of Entre Ríos in Argentina. 
Irina Alborva (Eurasia)
 
Irina has over three years of experience working in regulatory and quality assurance for medical devices. At Arazy Group, Irina works as a Medtech Regulatory Affairs Expert where she leads market clearance and registration projects in Russia. Prior to this, Irina worked for Johnson & Johnson Russia as a Regulatory and Quality Specialist. Irina is a highly skilled engineer with a PhD in Technical Science – Medical Devices from Bauman Moscow State Technical University and has an additional seven years of experience in the design and development of Medical Devices.
Edit Zur (Southeast Asia)
 
Edit has gained over seven years of regulatory experience while working at Arazy Group as a Senior Client Manager and Project Manager since 2013. Edit has extensive experience monitoring licenses, certificates and managing many different clients' regulatory projects. Her expertise is working in Southeast Asian countries such as the Phillipeans, South Korea  and China, and has worked on over a hundred projects while at Arazy Group.  Edit has completed her degree in Industrial Engineering and Management at Ort Braude College. 
Ana Lucia Puigvert (Latin America and Eurasia)
 
Ana Lucia has worked in regulatory affairs for over ten years and has worked as a Project Manager at Arazy Group since 2016 where she has worked on over 200 projects. Ana specializes in the Eurasian Union, African and Latin American markets as a senior regulatory affairs specialist where she is responsible for submissions and developing strategies for multicountry approvals. Prior to Arazy Group, Ana worked in regulatory at the Argentinian branch of Natus Medical and at Beckman Coulter as well as completed her Biomed Engineering degree at the National University of Entre Ríos in Argentina.
Idan Vivante (Southeast Asia)
 
Idan has worked in regulatory affairs for over ten years as a Regulatory Expert and Project Manager at Arazy Group Consultants since 2010. His expertise includes preparing and reviewing technical files, managing clinical research and regulatory projects, specializing in the Southeast Asia, Oceania and MENA countries. Idan has completed a Masters degree in Biotechnology at Ort Braude College with a focus on clinical research. Prior to Arazy Group, Idan completed Clinical Research for the orthropedic department at Rambam Health Centre. 
WHO SHOULD ATTEND?
This series is suitable for managers, leads and other relevant job titles in the medical and IVD industry such as:
CEO
VP, Regulatory Affairs
Director, Regulatory Affairs
Regulatory Affairs Managers and Associates
VP, International Business Development 
Director, International Business Development 
Business Development Managers
VP, International Sales
Director, International Sales
and anyone else interested in global medtech market access 
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