Navigating the EU Medical Device Regulation | Event 2: For Companies with Knowledge of the EUMDR
10/05/2023

About

You have two, FREE, virtual events to choose from focused on Navigating the EU MDR. 
This is Event 2 registration, a detailed EU MDR presentation specifically for companies with knowledge of the EU.
Event 1 is for new to the EU companies, it will take place on Tuesday, September 26. Registration here. 

Webinar Overview
·       What does EU MDR mean for your bottom line?
·       Learn how to navigate the EUMDR from:
Nina Brkuljan, Senior Commercial Specialist, U.S. Mission to the European Union, and
Maria Duguine, PhD Chemistry, Consultant, RQMIS (EU/UK/US regulatory consulting firm)
·       Understand the forces behind the regulation and the current implementation strategy.
·       Learn the certification process, time commitment and resources needed to be successful.

Who Should Attend?
·       Medical device producers including (stents, catheters)
·       Medication producers that use certain applicators
·       Certain cosmetics and food supplement producers
Gain knowledge about MDR, how it applies to your products, and more!

What is EU MDR?
The Medical Device Regulation (MDR) changed the European legal framework for medical devices and introduced new responsibilities for the European Medicines Agency (EMA) and for national authorities in the assessment of certain categories of products.

The MDR introduces new or revised responsibilities for EMA for:
·       Medicines with an integral device, such as pre-filled syringes and pens, and pre-filled inhalers;
·       Medical devices containing an ancillary medicinal substance to support the proper functioning of the device, for example drug-eluting stents, bone cement containing an antibiotic, catheters coated with an antibiotic agent and condoms coated with spermicides;
·      Medical devices made from substances that are absorbed by the human body to achieve their intended purpose; and
·      Borderline products for which there is uncertainty over which regulatory framework applies. Common borderlines are between medicinal products, medical devices, cosmetics, biocidal products, herbal medicines and food supplements (European Medicines Agency, 2022)

Selling or planning to sell to the EU - you won’t want to miss this!

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Agenda
05
Event 2: Navigating the EU Medical Device Regulation
Event 2: Navigating the EU Medical Device Regulation
11:00 - Welcome by Jacqueline Torcellini, U.S. Commercial Service (Domestic Team)
11:05 - Introduction by Lourdes Castellanos, U.S. Commecial Service (Düsseldorf)
11:10 - Speaker Introductions  by Jacqueline Torcellini, U.S. Commercial Service (Domestic Team)
11:15 - TBD by Maria Duguine, PhD.,Regulatory/Quality Consultant, RQMIS
11:30 - TBD by Nina Brkuljan, Senior Commercial Specialist, U.S. Commecial Service (Brussels)
11:45 - Q&A
Start
11:00 AM
End
12:15 PM
Speakers

Jacqueline Torcellini

Jacqueline Torcellini is a Senior International Trade Specialist with the U.S. Commercial Service, a division of the U.S. Department of Commerce. She has been providing international business support for over a decade and has assisted scores of businesses to either start exporting or expand their existing international business.

Jacqueline holds a master’s degree in political science, International Relations from Southern Connecticut State University (SCSU). Her years of experience in business development, financial management, operations, training, and communications, turned out to be a great foundation from which to expand to the intricacies of conducting international business. Jacqueline believes U.S. companies can strengthen their business by diversifying their client portfolio through expansion to appropriate international markets. She is excited to be able to support U.S. companies by helping them: identify top markets for their products; determine the best market entry strategy; and harness the resources available to them on the federal and state level.

Lourdes Castellanos

Lourdes Castellanos, Commercial Specialist
U.S. Commercial Service - Dusseldorf

Lourdes Castellanos joined the CS Dusseldorf Team in October 2022. Prior to working for the Commercial Service, Lourdes worked for the U.S. Department of State at the General Consulate in Frankfurt. From  2014 - 2019, she supported the U.S. Embassy in Mexico City as the Senior Marketing Specialist for the Foreign Agricultural Service. 

Lourdes holds a B.A. in Communications and Journalism as well as an M.A. in Corporate Communications and Crisis Management, she speaks English, Spanish and German.

Maria Duguine, PhD Chemistry, Consultant, RQMIS

Nina Brkuljan

Senior Commercial Specialist, U.S. Mission to the European Union

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