Impact of MDR on Drug-Device Combination Products: Notified Body Opinion and CE Mark Applications

6.0
RAC Credits
Virtual Programs Virtual Programs
Thursday, 16 December 2021 (9:00 AM) - Thursday, 16 December 2021 (2:00 PM) Eastern Time (US & Canada)

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.

Learning Objectives

Register now and learn how to:

  • Understand what a drug-device combination product is and know the delimitation to other products
  • Identify main challenges during drug-device combination product approvals and know mitigation strategies
  • Identify the issues to align with the Notified Body prior to dossier development to facilitate the dossier review
  • Prepare a submission and approval pathway for drug-device combination products according to Article 117 MDR
  • Understand how to develop a complete dossier for Notified Body review including contents and level of detail

Pricing Amounts & Deadlines 

Regular $580.00 Member | $680.00 Nonmember

Who Should Attend? 

Any industry representative that is either in the EU now or intending to pursue commercialization in the EU market.

Audience Learning Level

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.


Agenda

9:00 am – 9:05 am Housekeeping & Introductions
9:05 am – 9:35 am

Device Led Combination Products – Definitions, Process, Submission Requirements

  • Technical File Requirements for CE mark

Dr. Med. Isabelle Lang-Zwosta, Global Regulatory Affairs and Business Development, Health Care Medical Devices, Knoell Medical Devices, LLC

9:35 am – 10:05 am

Drug Led Combination Products – Definitions, Process, Submission Requirements

  • Article 117 Submission
    • Impact on timelines
    • NB Opinion Request: content requirements (GSPR, tch file and source reports)
    • MAA Dossier Requirements (EMA guideline on CMC)

Federica Rusmini, Associate Director, CMC Dossier Development, The Janssen Pharmaceutical Companies of Johnson & Johnson

10:05 – 10:35 am

Notified Body Processes & Expectations

  • Requirements
  • Procedure
  • Common Pitfalls
  • Thoughts on divergence of opinions
    • Uniformity of opinions?
  • Time to process
  • Guidance Docs

Julia Frese, Director, Medical Health Services Japan, TÜV SÜD

10:35 am - 11:20 am Quality Requirements
  • Application GSPR Checklist to real-world devices
  • Integrated risk management

Amit Khanolkar, Senior Director of Combination Products - Quality, The Janssen Pharmaceutical Companies of Johnson & Johnson

11:20 am – 12:00 pm Lunch Break
12:00 pm – 12:35 pm Practical Regulatory Considerations
  • Approved product with new device
  • Regulations have been updated since approval of DP & how to handle (significant changes)
  • CTA of combination product
  • Class 1 combination products
  • Labeling

Peter Dorski, Associate Director CMC-RA, The Janssen Pharmaceutical Companies of Johnson & Johnson

12:35 pm – 2:00 pm Panel Discussion and Q&A
  • Packaged product of combination product and device without CE (at what point of use does it become a combination product)
  • CER
  • Same device across different products
  • Post-market Surveillance

Moderated by Deborah M. Schachter, PhD, MBA, Scientific Director, The Janssen Pharmaceutical Companies of Johnson & Johnson

*Agenda subject to change.


Lead Faculty

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

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.


Speaker(s)


Peter Dorski

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

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

Amit Khanolkar, Senior Director of Combination Products - Quality,The Janssen Pharmaceutical Companies of Johnson & Johnson


Dr. Med. Isabelle Lang-Zwosta

Dr. Med. Isabelle Lang-Zwosta, Global Regulatory Affairs and Business Development, Health Care Medical Devices, Knoell Medical Devices, LLC


Federica Rusmini

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.



Cancellation Policy

RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation. 

All cancellation requests must be submitted in writing to support@raps.org. RAPS is unable to accept cancellations by phone. 

Paid registration substitutions may be accepted with written approval from RAPS for requests received before the start of the event. To transfer a registration, email support@raps.org with the event title, name of the original registrant and the contact information for the new attendee. 


Proof of Attendance

RAPS will send an electronic letter or a certificate of attendance at the following the workshop.


Questions

Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email support@raps.org  

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