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2021 UPS_1988x680

2021 PDA Combination Products and the Regulatory Framework Workshop

A Hands-on Journey to MDR Article 117 – A License (not) to Kill your Products Market Access

Oct 04, 2021
Central Europe Standard Time | Online
  • Virtual
  • Online
  • Europe
Program Highlights

Join this one-day interactive online workshop preceding The Universe of Pre-filled Syringes and Injection Devices and gain a deeper insight to the MDR Article 117

Overview

Dear Colleagues, 

The 2021 PDA Combination Products and the Regulatory Framework Workshop will be taking a novel approach to a familiar topic! During the past workshops, the application of MDR article 117 was intensively discussed and strategies have been laid out on how to best address the numerous open regulatory hurdles. Now, we are well into the implementation of the MDR, and first hands-on experience has been gathered on what it means to get a notified body opinion for the device part of your combination product.

Therefore, we would like to take the opportunity to peek into real-life industry case studies and applications. The involved parties (manufacturers, marketing authorization holders and notified bodies) have embarked on a joint journey to minimize risks to the patient. Also, the efforts on both sides should be efficiently reduced by establishing a pragmatic approach, especially when regulatory guidance is still sparse.

We invite you to hear the latest lessons learned and best practice approaches from industry and regulatory bodies on getting a notified body opinion and on the impact of use errors and risk management. Get involved with your own experience and exchange your thoughts on the current challenges around MDR 117 and understand the target of a Notified Body Opinion. 

In order to maximize the benefit of this workshop we would like the attendees to participate actively in interactive live video group discussions and practical exercises, involving the simulated application of combination products. This enables the participants and speakers to go through the major potential roadblocks that need to be addressed for a good baseline and further exchange with the parties involved and thereby generate practical take-home messages for all participants.

We look forward to welcoming you online!

Sincerely,  

The Workshop Lead,  

Egmont Semmler, TÜV Süd 

WORKSHOP COMMITTEE:
Egmont Semmler, TÜV Süd
Stephanie Göbel, Beyond Conception
Michael Karl Ledinegg, Sandoz - Novartis
Mike Wallenstein, Novartis

Agenda

  • Monday, 04 October 2021

    12:00 - 17:00 CEST

    Welcome & Introduction Egmont Semmler, TÜV Süd
    Overview and Introductory Talks
    An Overview of the Current Status of Devices and their Regulatory Framework Michael Karl Ledinegg, Sandoz - Novartis
    A Journey to MDR Article 117: A case study on a real-life product and how to establish a Notified Body Opinion Novo Nordisk & TÜV Süd
    Notified Body Opinions - Lessons Learned and How to Satisfy the Notified Body to Avoid Delay in Time-To-Market Mike Wallenstein, Novartis
    Usability, the Impact of Human Touch and Risk Management for Combination Products Stephanie Göbel, Beyond Conception
    Live Q&A and Discussion

    Break

    Interactive Working Groups – Identifying Common Pitfalls in the Application Process
    After parting in 2 groups, the participants will enter a moderated discussion on administrative and content related questions. Facilitated by table moderators, each group is introduced to the topic and will have a set amount of time to discuss and gather key points on each topic. The results will be documented for further discussion and groups will switch midway through the session, so everyone has the chance to address all questions. A concrete take-home-message will be shared after the event with all attendees.
    Introduction to the Working Group Format Michael Karl Ledinegg, Sandoz - Novartis
    Addressing Regulatory Challenges
    • Notified Body Opinion

    Moderators:
    Michael Karl Ledinegg, Sandoz - Novartis
    Mike Wallenstein, Novartis
    Addressing Content Related Challenges
    • Usability
    • Risk Management

    Moderators:
    Stephanie Göbel, Beyond Conception
    Egmont Semmler, TÜV Süd

    Break

    Summary of the Working Groups by the Table Moderators
    • Addressing questions raised in the working groups
    • Discuss different stakeholders’ perspectives

    Final Discussion & Q&A
    • A checklist will be compiled based on conclusive results from the group work and discussions
    Farewell and End of Workshop Egmont Semmler, TÜV Süd

Highlighted Speakers

Stephanie Goebel
Stephanie Goebel
BeyondConsulting
Michael Karl Ledinegg
Michael Karl Ledinegg
Sandoz
Egmont Semmler
Egmont Semmler
TÜV Süd
Mike Wallenstein
Mike Wallenstein
Novartis

Learning Objectives

Upon participation of this workshop you will be able to: 

  • Learn how real device applications for a Notified Body Opinion were handled by Notified Bodies and what the lessons learned are for all parties.
  • Understand the most common misunderstandings between the risk mitigation processes from Pharma Industry side versus the Notified Body perspective.
  • Learn to identify the regulatory gaps from the already existing drug device information to the requirements of the Notified Bodies (e.g. device usability, functional safety, risk management) and gain insights on how to adapt your internal processes.
  • Understand what a Notified Body Opinion is and what are the key elements to be addressed, such as e.g. usability, functional safety aspects, patient population considerations in risk control or design change management.

Who Should Attend

The target audience for this workshop is from departments like Device Development, Compliance, Operations, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Business Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Control, Clinical Affairs. 

Registration Fees

Register Now
Registration Type Price
All Participants €795

All fees given in Euro and excluding VAT

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