Innovative Drug Delivery Systems/Combination Products Workshop

Gothenburg, Sweden
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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.

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.

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 

Standard Pricing

Standard Member Price

€795

GovernmentMember Only

€795

Health AuthorityMember Only

€795

Early Career ProfessionalMember Only

€795

StudentMember Only

€795

AcademicMember Only

€795

Non-Member

€795

See Qualifying Criteria for Member Types.

ALL PRICES IN EURO (EUR), EXCLUDING VAT.

WAYS TO REGISTER: 1. Online Registration   2. [email protected]

PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.

If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.

Day 1

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


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 , Sweden

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!

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!
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.