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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 your product CE marked. 

Therefore, we’d like to take the opportunity to peek into real-life industry case studies and applications. The involved parties (Manufacturers 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 to MDR 117 on the way to CE marking.  

In every case all parties had to learn from each other on the mutual requirements and find a joint solution that works for both. 

We would like to take up this very important aspect of collaborative learning and encourage a discussion around the different perspectives of Manufacturers and Notified Bodies amongst the participants. We invite you to hear the latest lessons learned from industry and regulatory bodies and get involved with your own experience and exchange your thoughts on the current challenges around MDR 117.  

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 generic combinational 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 involved Regulatory Bodies and thereby generate practical take-home messages for all parties. 

Sincerely,  

The Workshop Lead,  

Egmont Semmler, TÜV Süd 

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

Agenda


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 about how real device applications have progressed on their rocky road to CE marking and what are the lessons-learned 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) and get ideas on how to adapt your internal processes.

    • Understand what is needed to avoid common mistakes during the application process and reduce the efforts on both sides.

  • 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. 

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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 discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to [email protected]. Phone messages are not accepted.

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Tel: +1 (301) 656-5900 ext. 115
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