Decoding Article 117 of Medical Device Regulation 2017/745 as applicable to integral drug-device combination products
Sponsored by: Aptar Pharma
- Medical Device Regulation
- Drug Delivery Device
- Combination Products
Date: 26 May
Time: 3PM BST / 10AM EST / 4PM CET
Exploring the current situation, challenges & solutions
Replacing the Medical Devices Directive (MDD) 93/42/EEC, the Medical Devices Regulation (MDR) 2017/745 will provide greater safety for patients and better transparency for all stakeholders. Manufacturers need to comply for both existing and new technologies. This includes drug-device combination products that form a non-reusable, single, integral product exclusively used to administer the medicinal product, under the requirements of Article 117. Article 117 introduces the notion of risk-classification, and accordingly to involve a Notified Body as a new stakeholder in the medicinal product’s Marketing Authorization Application (MAA) process in Europe.
This webinar will explain the Article 117 requirements 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. Back in 2019 the European Medicines Agency (EMA) published in draft guidance and Q&A; however, many questions remain, which we will review during this webinar. The EMA is proposing a collaborative workshop across all stakeholders to help clarify Article 117 implementation and translate this into a final EMA guideline. This multi-stakeholder workshop is currently postponed due to the COVID-19 pandemic, so we will share our current view on how to get prepared for Article 117.
Attendees will gain a greater understanding of the impact of MDR’s Article 117 on all stakeholders involved in a single integral drug-device combination product’s development, the approval process and lifecycle management.
Global Regulatory Affairs Director
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.
Krystel Limouzin's Linkedin Profile
Associate Director – Regulatory Affairs
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.
Andrew Woods Linkedin Profile
Key Learning Objectives
- Baseline knowledge on MDR’s Article 117 requirements for single integral drug-device combination products
- Overview of the current situation and challenges from EU regulators’ and Industry’s points of view
- Current Industry preparation for the EMA multi-stakeholder workshop
- Food for thought to internally plan for Article 117 implementation
- Regulatory Affairs Managers
- Packaging Development Product and Project Managers
- Business Development Managers
- Quality Assurance Managers
- Academic Researchers