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PDA Europe Webinar - The Medical Device Regulation: Guidance for Pre-filled Syringes and Combination Products

Nov 19, 2020
4:00 PM
-
5:30 PM
| Central Europe Standard Time
Online
  • Virtual
  • Webinar
  • Online
  • Europe

Overview

Dear Colleagues, 

The new regulation on medical devices EU 2017/745 has provided a more detailed definition of the Drug Device Combination Products (DDCs) in the EU, covering also quality and regulatory requirements.  

For integrated DDCs intended to administer a medicinal product, article 117 also amends the Directive 2001/83/EC, requiring the applicant to include the results of the assessment of the conformity of the device constituent with the relevant General Safety and Performance Requirements (GSPR) in the marketing authorization dossier. 

These changes have increased the discussion among the container closure system manufacturers, as it seems not fully clear how a sub-assembled device can be demonstrated to fulfil regulatory expectations. 

This PDA Webinar therefore aims to address relevant industry stakeholders interested in collaborating on a Technical Report document to support component manufacturers in providing the applicant with the appropriate information on device conformity with the relevant GSPR.  

The discussion will involve industry representatives as well as provide Notified Body Opinion. 

We look forward to constructive collaboration and problem solving, and warmly invite you to join us! 

Agenda

  • Introduction

    Impact of the MDR on the Prefilled Syringes Market

    Applicability of Standards and GSPR to the Device Constituent of Prefilled Syringes

    Andrea Salmaso, Stevanato Group
    PFS and Combination Products Design and Development

    Design Control Ring Definition of the Device Constituent Part

    Design Verification, Validation and Risk Management Challenges

    Fabrizio Bacelle, Stevanato Group
    Technical, Quality and Safety Information Requirements in Annex I Applicable for Prefilled Syringes and Major Implications

    Applicable Sections of Annex I

    Expectations for Compatibility and Clinical Requirements

    Ankica Jakovljevic, Stevanato Group
    Notified Body Opinion
    Drug-Device Combination Products: Regulatory Framework Under MDR Article 117
    Simone Antonini, TÜV Rheinland
    PDA Technical Report Proposal Andrea Salmaso, Stevanato Group
    Interactive Live Q&A and Discussion

Highlighted Speakers

Simone Antonini
Simone Antonini
TÜV Rheinland Italia
Fabrizio Bacelle
Fabrizio Bacelle
Stevanato Group
Ankica Jakovljevic
Ankica Jakovljevic
Stevanato Group
Andrea Salmaso
Andrea Salmaso
Stevanato Group

Registration Fees

Register Now
Registration Type Price
All Participants €199

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