Webinars, Pharmaceutical

Aptar Pharma discusses Article 117 of the Medical Device Regulations

The Medical Devices Regulation (MDR) 2017/745, which replaces the Medical Devices Directive (MDD) 93/42/EEC, will provide greater safety for patients and better transparency for all stakeholders. This webinar explains requirements associated with Article 117 of the MDR for single integral drug-device combination products, providing an overview of the current situation and the challenges ahead, from both the Authorities’ and Industry perspectives. Manufacturers need to comply for both existing and new technologies, including drug-device combination products that form a non-reusable, single, integral product exclusively used to administer the medicinal product. Remaining questions relating to Article 117 are reviewed and views on how to get prepared for its implementation are shared. Viewers will gain a greater understanding of the impact of Article 117 on all stakeholders involved in a single integral drug-device combination product’s development, the approval process and lifecycle management.

May 26, 2020 5:00 PM London / 12:00 PM New York 1 Hour
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Presented by Krystel Limouzin Andrew Wood
26 May 2020

Presented By

Krystel Limouzin

Global Regulatory Affairs Director, Aptar Pharma

Krystel Limouzin is an engineer, having received her engineering degree in pharmaceutical sciences from the faculty of pharmacy of Montpellier, France, with a master’s degree in regulatory affairs from the faculty of pharmacy of Châtenay-Malabry, Paris, France. She has over 20 years of regulatory affairs experience in pharma, medical devices and container-closure systems/combination products environments. She started her regulatory affairs carreer in national and international pharmaceutical companies, and then moved to the container-closure systems and parenteral drug-delivery devices sectors. In the past years she was in charge of global medical regulatory affairs for an international medical company, and more recently in 2019, she joined Aptar Pharma as Global Regulatory Affairs Director, to manage the regulatory affairs teams and activities for Aptar Pharma globally.

Andrew Wood

Associate Director – Regulatory Affairs, Aptar Pharma

Andrew Wood has more than thirty years’ experience in the OINDP (Orally Inhaled and Nasal Drug Product) industry. Initially working as Quality Manager for a device manufacturing company, he then spent many years with a major pharmaceutical company as device technical support for development and launch of inhalation combination products. He joined Aptar twelve years ago as Associate Director for Regulatory Affairs, supporting many clients through regulatory approvals of OINDPs in all world markets.

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