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2021 UPS_1988x680

2021 PDA Combination Products and the Regulatory Framework Workshop

Oct 04, 2021
Gothenburg, Sweden

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

  • Workshop
  • Europe

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Program Highlights

Join this one-day hands-on 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 round table 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.

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

    10:00 - 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
    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

    Coffee 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

    Lunch Break

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

    Coffee Break

    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

Additional Information

  • Learning Objectives

    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

    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. 

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

Make a Reservation
The Swedish Exhibition & Congress Centre Gothia Towers Hotel

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden


Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2021. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.

You can book your Hotel Accomodation here!
  • Accommodations

    The Swedish Exhibition & Congress Centre Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg, Sweden


    Hotel Accommodation

    optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2021. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting the conference hotel.

    You can book your Hotel Accomodation here!
  • Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone:
+46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price
Registration Type Price
All Participants €795

All fees given in Euro and excluding VAT (25%)

* For this member type or discount, online registration is not available, please contact [email protected].

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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