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This is a recording from December 2021
Integral drug-device combinations where the medicinal product and the medical device are combined to form an integral product are subject to the EU Medical Device Regulation (MDR) 2017/745.
Where the action of the medical device is principal, application to a Notified Body (NB) is required. Where the action of the medicinal product is principal, Article 117 of the MDR includes a pre-requisite of obtaining an NB opinion prior to submission of the MAA.
Like medical devices applying for CE Mark, the pharma company is required to prepare a submission with evidence of compliance of the device with the GSP, though most pharma companies have not had interactions with an NB in the past.
Join medical device, pharm industry and notified body representatives to explore the technical documentation requirements for CE Mark and for NB opinion and dossier requirements for MA applications.
Register now and learn how to:
Regular $580.00 Member | $680.00 Nonmember
Any industry representative that is either in the EU now or intending to pursue commercialization in the EU market.
Basic: Content is introductory in nature and requires no requisite knowledge or experience to grasp concepts and related exercises. Basic educational activities are meant to establish a foundation of knowledge and/or competence that will be expanded upon in practice or in higher level activities.
Device Led Combination Products – Definitions, Process, Submission Requirements
Dr. Med. Isabelle Lang-Zwosta, Global Regulatory Affairs and Business Development, Health Care Medical Devices, Knoell Medical Devices, LLC
Drug Led Combination Products – Definitions, Process, Submission Requirements
Federica Rusmini, Associate Director, CMC Dossier Development, The Janssen Pharmaceutical Companies of Johnson & Johnson
Notified Body Processes & Expectations
Julia Frese, Director, Medical Health Services Japan, TÜV SÜD
Amit Khanolkar, Senior Director of Combination Products - Quality, The Janssen Pharmaceutical Companies of Johnson & Johnson
Peter Dorski, Associate Director CMC-RA, The Janssen Pharmaceutical Companies of Johnson & Johnson
Moderated by Deborah M. Schachter, PhD, MBA, Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
*Agenda subject to change.
Deborah M. Schachter, PhD, Scientific Director, Janssen R&D, LLC
Deborah Schachter is a Scientific Director at Janssen Research and Development, LLC. Dr. Schachter has a Ph.D. and MBA from Rutgers University, and a B.A. in Chemistry from NYU. Deborah has more than 20 years of combination product experience and is currently responsible for the strategy development and execution of the combination product dossier content and standards for both small and large molecule drug product CTA, BLA, and MAA dossiers. In collaboration with other Janssen stakeholders, Dr. Schachter directed the dossier development for a wide range of combination products that have achieved world-wide approval. Prior to Janssen, Dr. Schachter was a R&D group leader at Ethicon and Depuy, responsible for the development of combination products for orthopedic and sustained drug delivery applications. Dr. Schachter is the primary inventor on 7 US PTO-issued patents.
Bassil Akra, CEO, AKRA TEAM GmbH
Julia Frese, Director, Medical Health Services, TÜV SÜD
Amit Khanolkar, Senior Director of Combination Products - Quality,The Janssen Pharmaceutical Companies of Johnson & Johnson
Federica Rusmini, Associate Director, The Janssen Pharmaceutical Companies of Johnson & Johnson
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