Drug-Device combination products in EU and US

  • 1° EDIZIONE: 27-28 Novembre 2024
  • 2° EDIZIONE: 10-11 Giugno 2025
  • Online
  • Inglese

Contenuto del corso

The training course “Drug-device combination products in EU and US” will explore the EU and US regulatory landscape defining the key differences, similarities and provide an overview of the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction.
The course will also provide a detailed overview of impact of the EU medical device regulation on combination products and the life cycle management of combination products.
Enhancing capabilities to develop and launch successful combination products will remain a top priority; with product usability, integrating digital platforms and general management across the total product life cycle becoming critical.
However, with a regulatory landscape that is inconsistent between EU and US, remaining compliant, maintaining quality and ensuring safety requires clear, concise and consistent guidance on regulations.

Are you interested in Medical Device training?

Enroll in 3 courses and you’ll get a 15% discount*, while choosing 5 courses will grant you a 20% discount*!
Choose among these titles:

(*) discounts apply to the full prices of the courses and cannot be combined with other promotions.
The promotion is limited to enrolling the same person in 3 or 5 courses selected from those offered.

Cosa saprai fare dopo il corso?

  • Understand how combination products are defined and classified in EU and US
  • Learn how borderline products are classified in EU and US
  • Understand the regulatory pathways and how to successfully navigate between drugs, devices and combination products in each jurisdiction
  • Learn about the EU Medical Device Regulation impact on Combination Products
  • Gain a deeper understanding of the roles of EU Competent Authorities and Notified Bodies
Struttura del corso

09:30– 13:00 COURSE SESSION DAY 1
09:30– 13:00 COURSE SESSION DAY 2

Programma

Day 1

9:30 Introduction & speed networking

9:40 Combination Products in EU

  • Definitions in EU
    • Combination Product
    • Medicinal Product
    • Medical Device
  • Legal framework
    • Medicinal product and medical device legislations
    • Revision to EU Medical Device Regulation (MDR)
    • Regulatory similarities and differences
  • Borderline classification in EU: Medical Device or Medicinal product?
    • The importance of classification & its implication
    • Decision Making on the Borderline

Q&A time

10:20 EU Market access for Drug Device Combination Products (DDCs)

  • Single integral non-reusable DDCs
  • Non-integral Combination Products (kit)
  • Data requirements
  • Labelling requirements
  • Guidance documents

Q&A time

11:25 Break

11:45 Combination Products in US

  • Combination Product Definition
  • History and Legal Framework
  • Borderline Products
  • Types of Combination Product (Definitions)
  • Primary Mode of Action and FDA’s Assignment Algorithm
  • Jurisdiction and Designation Process for Combination Products

Q&A time

13:00 Closure of day one

DAY 2

9:30 EU market access for Device Drug Combination Products

  • EU MDR Classification and applicable rule(s)
  • Notified Body’s role and obligations
  • What is CE Marking?
  • CE certification process at a glance
  • Documentation requirements at top level

Q&A time

 10:15 EU MDR key changes and its Impact on Drug Device Combination Products 

  • Impact on combination products regulated as medicinal product
  • Article 117 and Notified Body Opinion report (NBOp)
  • Notified Body selection and Interaction
  • Documentation requirements
  • Life Cycle management: New or updated NBOp?
    • Team-NB position
    • Industry perspective

Q&A time

11:00 Break

11:20 US market access for Combination Products

  • FDA’s approach to Combination Products
  • Submissions and Regulatory Pathways
  • Current Good Manufacturing Practice (cGMP) Requirements
  • Strategies for Development of Combination Products

Q&A time

12:30 Conclusion 

12:40 Final Questions session

This Training Course is of particular interest to professionals working in:

  • Quality Assurance
  • Quality Control
  • Regulatory Affairs
  • Design and development of Combination Products
  • Suppling medical devices to the pharma/biotech industry

Il corso si sviluppa attraverso lezioni frontali. Grazie ad una metodologia didattica interattiva con presentazione ed esempi pratici, i partecipanti potranno avere spunti da poter applicare nella loro realtà professionale.

Se il corso è online, il link di partecipazione verrà inviato 2-3 giorni prima dell’inizio del corso.

Sconto del 5% per le iscrizioni entro 1 mese dal corso, sconto del 10% per le iscrizioni entro 2 mesi dal corso. I prezzi sono da intendersi IVA esclusa. Le offerte non sono cumulabili. Per sconti su iscrizioni multiple rivolgersi a info@pharmaeducationcenter.it

Modalità di cancellazione

Si richiede di comunicare la disdetta all’evento formativo inviando un’e-mail a info@pharmaeducationcenter.it entro due settimane dalla data di inizio dello stesso. Trascorso tale termine, si procederà con l’addebito dell’intera quota.

Modalità di sostituzione partecipante

Si prevede la possibilità di cambiare il nome del partecipante all’evento formativo, senza alcun costo aggiuntivo, inviando un’e-mail a: info@pharmaeducationcenter.it. Si chiede di dare comunicazione entro una settimana dalla data di inizio dello stesso indicando il nome del primo iscritto e il nome del sostituto.

Condizioni di annullamento o rinvio

Pharma Education Center si riserva la facoltà di annullare o posticipare l’evento formativo nel caso in cui non si raggiunga un numero minimo di partecipanti. Pharma Education Center si impegna a restituire la quota d’iscrizione già versata senza ulteriori oneri o su richiesta dell’iscritto concedere un bonus spendibile per la partecipazione ad un altro evento formativo in programma nell’anno corrente.

Docenti

Tina Amini

Tina Amini

TA MedTech & Combination Products Consulting Ltd

Tina Amini was recently a director of medical device divison at NDA Group AB where she has been supporting MedTech and Pharma companies with their medical devices, in vitro diagnostic devices (IVD) including companion diagnostics and combination products. Tina formerly held the positions of Head of Notified Body and Senior Technical Specialist at LRQA Notified Body and Pharmaceutical & Medical Device Expert at BSI Notified Body, where she was responsible for device/drug combination products, Conformity Assessment of a wide range of medical devices and onsite assessments of Quality Management Systems (QMS) as the lead auditor. Tina was also involved in the classification of borderline products, EU pre-submission scientific advice procedures for medical devices, the consultation process with several EU competent authorities and EMA for device/drug products. She was a member of Team-NB Working Group: Borderline issues and new technologies, Classification and borderline; Post Market and Clinical. Prior to joining Notified Bodies, Tina worked in the pharmaceutical industry on the development of medicinal products and combination products in several therapeutic areas.

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Early Bird 10%
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855€
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Valido fino a 1 mese dal corso
900€
950€
Full price

950€

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