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.

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, CEO, AKRA TEAM GmbH

Speaker(s)

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

Julia Frese, Director, Medical Health Services, TÜV SÜD

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

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

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

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