Hybrid Event, 20 - 24 June 2022
In-Person: Clayton Hotel Burlington Road, Dublin, Ireland,
Digital Experience: One track will be live-streamed each day in BST time zone, with on-demand recording access for all other tracks made available from the afternoon of the following day. Learn more on the Digital Experience page.

MDR Article 117. Borderline Products Guidance. Regulatory Pathways: EU vs US. Get Your Head In The Game…

With guidance updates and feedback from the EU Commission, Ministry of Health, Notified Body and leading industry experts

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Navigate The Regulatory Requirements For Drug Device Combination and Borderline Products

Industry leading discussions from EU Commission, Notified Bodies and Industry Representatives

Guidance on classification and borderline products from the EU Commission and Dutch Health and Youth Care Inspectorate (IGJ)
Case study example from Novartis on obtaining NBOs under Article 117
Concise working group with Janssen on design control and development

Latest regulatory updates explained

Drug to device FDA status transition – who is affected?
Changes in classification guidance under Regulation (EU) 2017/745 on medical devices
Determining critical tasks for human factors validation tests

Elsewhere at the MedTech Summit...

Take a look at the 8 other MedTech Summit conference tracks to see what else is on the agenda for you:

Hear from Latham & Watkins on the legal challenges associated with combination products under MDR
Take a comprehensive dive into combination products under Article 117 with Fresenius Kabi Deutschland GmbH
Discover best practices for successful implementation of PMS for DDCPs

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Advance Your Drug Device Combination Products and Borderline Products Regulatory Know-How With Feedback From The Expert Speaker Line-Up

Sabina Hoekstra-van den Bosch, PharmD FRAPS

Regulatory Strategy Principal

TÜV SÜD

Prasad Peri

Senior Director Global Regulatory Affairs CMC (Small Molecules, Biologics, and Combination Products)

Teva Pharmaceuticals

Ryan Magee

Global Device Engineering (GDE) Director, Validation and Engineering

Mallinckrodt Pharmaceuticals Ireland Ltd

Mike Wallenstein

Global Head Novartis MDR Implementation, External Engagement & DD&C Compliance

Novartis Pharma AG

Meet The Speakers

Elsewhere At MedTech Summit

Medical Device Regulations in Global Markets

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