Q&A Regulatory Series for Turkish Medtech
Manufacturers Entering New Global Markets in 2021
Presented by Arazy Group Consultants & AdviQual

15:00 Thursday, March 11:
USA Market
15:00 Thursday, April 1:
Eurasia Market
EAEU, Kazakhstan, Russia & Ukraine 
15:00 Wednesday, April 21:
Latin America Market
Argentina, Brazil, Colombia, Ecuador & Peru
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.
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.  
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.  
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. 
Business Development Director, AdviQual & DeSia Clinical
After having various management positions in the Finance sector, Tunca has changed his career pathway to transfer his experience in deriving new partners and customers for the leading MD and IVD consultancy companies of Turkey. Tunca hs over five years of experience at AdviQual, a solution partner of Medical Device manufacturers, providing guidance in qulaity, regulatory and clinical subjects, giving technical training and advice for complaince. 
Expert Panel
Ray Kelly 
(United States of America)
Ray Kelly has acted as the Chief Regulatory Officer at Arazy Group Consultants for over eight years where he has worked on hundreds of projects receiving FDA clearance. Ray has over 22 years of experience in regulatory affairs for medical devices and FDA/Hc submission. At Arazy Group, Ray has also developed successful regulatory strategies for 510(k)), MAF, HUD, CE, TGA, HC Licensing, CTA, Q-submission and Annual Reports (IDE/PMA) as well as managed experts and testing labs, globally, to complete client projects.  
Irina Alborova 
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.
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. 
Ana Lucia Puigvert
(Latin America)
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.
This series is suitable for managers, leads and other relevant job titles in the medical and IVD industry such as:
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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