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Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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
Dr. Bassil Akra is CEO and Owner of AKRA TEAM GmbH, a consultancy company which was founded in 2021 to support the various stakeholders in the healthcare system achieving their target in a highly regulated business area. He spent the last year consulting and supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products.
Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.
Peter Dorski, Associate Director CMC-RA, The Janssen Research and Development of Johnson & Johnson
Regulatory affairs professional with eight years of pharmaceutical and combination product development experience, including consulting experience ensuring communication and alignment of CMC regulatory strategies with global regulatory, supply chain, and commercial strategies. Direct experience interacting with global health authorities including FDA and EMA to develop global regulatory strategies for combination product development. Frequently provided device-specific regulatory guidance to internal and external development partners and stakeholders. Developed global regulatory strategies for and contribited to the preparation, review, and submission of clinical and marketing applications for drug-device combination products. Provided regulatory assessments and strategies to support numerous lifecycle management activities for commercial products. Developed and maintained products in various therapeutic areas including immunology, oncology, endocronology, and dermatology.
Julia Frese, Director, Medical Health Services, TÜV SÜD
As biomedical engineer with a Master degree in business administration I have gained experience in development, regulatory approval of combination devices and ATMP products. Since joining TÜV SÜD I am responsible for devices combined with an ancillary medicinal substance. With the introduction of the Article 117 MDR I am in the responsibility to develop this field in our organization. Currently Julia Frese is heading the division of Medical and Health Services at TÜV SÜD Japan and co-chairs the Team NB working group for article 117
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
A regulatory professional with over 10 years’ experience in the pharmaceutical industry shaping the Chemistry, Manufacturing and Control (CMC) dossier strategy of small molecules drugs and drug-device combination products for Clinical Trial Applications (CTA) and global Marketing Application (MA) filings. Currently acting as Co-chair of the TOPRA CMC Special Interest Network Steering Group.
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