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Innovative Drug Delivery Systems/Combination Products Workshop

Oct 21, 2019
Gothenburg, Sweden

Risk Management and the New European Medical Devices Regulation

  • Workshop
  • Europe
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Program Highlights

PDA is planning a series of workshops as a kick-off to the Universe of Pre-filled Syringes Meeting. The workshop topics are soon to be published – check the website regularly or to send us an email we will inform you when these go online.

Overview

The Workshop will focus on Risk Management and the New European Medical Devices Regulation and the challenges associated with the practical implementations.

Learn from suppliers’ latest solutions and hear guest speakers and industry experts share an outlook on what to expect with the implementation of the new EMDR and specific requirements for combination products. Interact with other participants and speakers during round table discussions and exchange on all issues vital for the success of your product. Interactive Group exercises will ensure conclusive and practical take-home-messages for the participants.

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Agenda

  • Monday, 21 October 2019

    10:00
    Welcome: Opening Remarks
    Falk Klar, PDA Europe
    Thomas Schoenknecht, Lonza

    Latest Trends in Device Commercialization
    Thomas Schoenknecht, Lonza

    • Inhalation products
    • Patch infusers/Large volume injections
    • Adherence Systems/Technologies

    Risk Management
    Moderator: Alphons Fakler, Novartis

    10:40
    Risk Management for Combination Products - Specific Requirements for Combination Products
    Alphons Fakler, Novartis

    11:10
    Coffee Break & Exhibition

    11:40
    Risk Management Exercise: Group Activity

    • Core principles in risk management: Severity, Occurrence, Harm and Hazard
    • Typical hazards with injection devices
    • Definition of occurrence of harm

    12:15
    Round Table Discussion

    13:00
    Lunch & Exhibition

    European New Medical Devices Regulation
    Moderator: Michael Karl Ledinegg, Sandoz

    14:00
    An Introduction to the European New Medical Devices Regulation and the Consequences for Combination Products
    Michael Karl Ledinegg, Sandoz

    • General Overview and Timelines
    • MDR product related aspects
    • MDR system related aspects
    • Identification of products

    14:30
    Round Table Discussion

    • Single Integral Drug Device Combinations under Article 117
    • Co-Packed Drug Device Combinations

    15:15
    Coffee Break & Exhibition

    Closing
    Moderator: Thomas Schoenknecht, LONZA

    15:45
    Summary of Roundtable Discussions
    Alphons Fakler, Novartis
    Michael Karl Ledinegg, Sandoz
    Thomas Schoenknecht, LONZA

    16:00
    Supplier presentations

    • Interactions with customers
    • Tech Transfer
    • Case Studies
    • Latest trends in specialized devices

    16:50
    Q&A, and Final Discussion

    17:00
    End of Workshop and Farewell
    Thomas Schoenknecht, LONZA
    Falk Klar, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    Upon participation of this workshop you will be able to:

    • Learn about the latest trends in commercialization of different devices such as inhalation products, patch
    • Understand the specific requirements for clinical trials, surveillance and classification of devices under the New European Medical Devices Regulation
    • Understand the core principles and requirements for risk management of combination products 
  • 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
Mässans Gata 24
41294 Gothenburg, Sweden

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. 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 2019. 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%)

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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