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

14:00 Thursday,  Feb. 25:
Eurasia 
EAEU, Kazakhstan, Russia & Ukraine 
 
14:00 Thursday, March 11:
Latin America
Argentina, Brazil, Colombia, Ecuador & Peru
 
14:00 Thursday, March 25:
Southeast Asia
Singapore, South Korea, Taiwan & Thailand 
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À PROPOS DE L'ÉVÉNEMENT​
REGtalks est une série informative qui repondra à toutes vos questions réglementaires spécifiques dans chaque marché. Notre objectif est de vous fournir des connaissances qui vous aideront dans votre parcours réglementaire vers de nouveaux marchés pour 2021. Cette série se déroulera en anglais.
INFORMATIONS SUR L'ACCÈS AU MARCHÉ
Chaque session fournira un aperçu de l'environnement réglementaire dans les marchés spécifiques. Nous couvrirons des informations sur le processus d'enregistrement, les exigences locales liées aux tests, la classification, les délais et plus encore pour chacun de ces marchés uniques.
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SESSION QUESTIONS PUIS REPONSES DE NOS EXPERTS
Obtenez les reponses à vos questions spécifiques par des professionnels de la réglementation pour chaque marché. Lors de cette session,vous aurez la possibilité de poser vos questions,nos experts locaux expérimentés y repondront.
TECHNOLOGIE RÉGLEMENTAIRE
Cette série montrera comment utiliser une technologie de pointe pour les activités d'enregistrement de projets telles que les demandes initiales d'enregistrements et les renouvellements dans les marchés sélectionnés. Nous vous expliquerons également comment tirer parti des exigences de conformité du marché pour accéder à d'autres pays.
SPEAKERS
Host
Joakim Gherbi 
French Country Account Manager
Arazy Group Consultants Inc.
Joakim Gherbi is a French Account Manager at Arazy Group Consultants and spent last year working with French Medtech companies, sharing his knowledge of Arazy Group's technology dedicated to registration of their devices internationally. Joakim has experience assisting the French market with starting registration projects in the EU, MENA region, USA (510(k), 513(g)), Canada (MDSAP), Australia, New Zealand, South America, Russia and Asia. Previously Joakim worked for large pharmaceutical groups in French-speaking countries.
Expert Panel
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.
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.
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. 
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. 
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. 
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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ARAZY GROUP CONSULTANTS
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