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2019 UPS

2019 The Universe of Pre-filled Syringes and Injection Devices

Oct 22 - Oct 23, 2019
Gothenburg, Sweden

Advancing Drug Delivery Systems to Improve Patients’ Lives

  • Conference
  • Europe

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Program Highlights

Dear Colleagues,

The Parenteral Drug Association warmly invites you to come and be part of this year’s Universe of Pre-filled Syringes and Injection Devices, for the first time in Sweden!

Since its first edition in 2004, the conference has become a fixture in the calendar for the pharmaceutical industry, and a must-attend event for everyone working in the fields related to parenteral drug and device development.

For its 16th year, the European event ventures out to the north of Europe to Gothenburg, Sweden. This amazing city is located at a key strategic location where river meets the sea. With its Dutch heritage, Gothenburg perfectly combines tradition and innovation, offering an overwhelming cultural diversity of the arts and the sciences.

Geographically situated in the center of Scandinavia with the largest port of that region, traditionally, trade, manufacturing, and industry have been the main contributors to the city’s wealth.

This signature PDA event will expose you to the vast net of the PDA family, a culturally and scientifically diverse melting pot. Coming to Gothenburg will offer you close to unlimited potential for identifying new business partners, meet fellow professionals, connect with international colleagues, and simply make new friends!

PDA has made every effort to create yet another impressive opportunity for you to gain access to key decision makers in the pharmaceutical industry. Meet government representatives, service providers, and manufacturers from all over the world this fall!

Join us in Gothenburg and be part of the world’s largest event on this subject.

Sincerely,

the Co-Chairs,

Mathias Romacker, Pfizer, Chair
Thomas Schoenknecht, Lonza, Chair

Overview

Scientific Program Planning Committee

Thomas Schoenknecht, Lonza, Chair
Mathias Romacker,
Pfizer, Chair
Frank Bamberg,
Hoffmann - La Roche
Theresa Bankston,
BD
Markus Bauss,
SHL-Connect
Sherri Biondi,
Medimmune
Nicolas Brandes,
West
William Dierick,
Terumo
Olivia Henderson,
Amgen
Laurent Jeanmart,
GSK
Philippe Lauwers,
Terumo
Hanns-Christian Mahler, 
Lonza
Manfred Maeder,
Novartis
Alessandro Morandotti,
OMPI
Brigitte Reutter-Härle,
Vetter
Thomas Seiffer,
Bausch + Ströbel
Ian Thompson,
Ypsomed
Karthik Vaideeswaran,
Eli Lilly
Falk Klar,
PDA Europe
Sylvia Becker,
Senior Programs & Events PDA Europe

Agenda

  • Day 1
  • Day 2
  • Tuesday, 22 October 2019

    9:00 – 9:30
    Welcome and Introduction
    PDA Awards

    Falk Klar, PDA Europe
    Thomas Schoenknecht, LONZA, Conference Chair
    Mathias Romacker, Pfizer, Conference Chair

    9:30 - 13:00
    Opening Plenary
    Moderators:
    Thomas Schoenknecht,
    LONZA
    Mathias Romacker, Pfizer

    KEYNOTE PRESENTATIONS: Regulatory & Technology Highlights

    9:30 - 9:55
    Novo Nordisk, Speaker invited

    9:55 - 10:20
    European Combination Devices Guideline
    Pascal Venneugues, European Medicines Agency

    10:20 - 10:35
    Challenges and Opportunities of Developing a Self-Injectable Platform for Global Health Applications
    Dennis Lee, Gates Foundation
    Robin Hwang, ICP Consulting

    10:45 - 11:30
    Coffee Break, Poster Session & Exhibition

    11:30 - 11:55
    Delivery Device Development in Midst of an Evolving Landscape of Novel Drug Modalities, Patient Centered Design and Digital Health
    Andrew Ratz, Eli Lilly

    11:55 - 12:20
    Life-Cycle Management of Combination Products
    Emily Razaqi, Amgen

    12:20 - 13:00
    Panel Discussion, Q&A

    13:00 - 14:30
    Lunch Break, Poster Session & Exhibition


    Demo Booths in the Exhibition Space

     

    Transition to Three Parallel Tracks

    14:30 - 16:00
    Session 1A: Human Factors
    Moderator: Sherri Biondi, AstraZeneca

    14:30 - 14:50
    Larger Injection Volumes, Longer Injection Times – Where are the Users' Limits with Handheld Devices?
    Jakob Lange, Ypsomed

    14:50 - 15:10
    Practical Pathways for Human Factors Regulatory Compliance for Parenteral Products
    Bjorg Hunter, GSK

    15:10 - 15:30
    Human Factors Perspectives on Leveraging a Platform Technology
    Nicholas Stones, Novartis

    15:30 - 16:00
    Q&A, Discussion

    14:30 - 16:00
    Session 1B: Polymer Containers
    Moderator: William Dierick, Terumo

    14:30 - 14:50
    Business Case and Journey of Launching a Biosimilar in a Polymer Prefilled Syringe in the International Market
    Yoshifumi Torii, Fujifilm Kyowa Kirin Biologics Co.

    14:50 - 15:10
    Polymer Prefilled Syringes and Cartridges - Process Technology Development and Handling Aspects for Successful Fill-And-Finish
    Harald Reber, Bausch+Stroebel

    15:10 - 15:30
    Excipients Effects on Functionality of Glass and Polymer Based Pre-filled Syringes
    Liang Fang, WEST

    15:30 - 16:00
    Q&A, Discussion

    14:30 - 16:00
    Session 1C: Regulatory Perspectives
    Moderator: Olivia Henderson, Amgen

    14:30 - 14:50
    An Opportunity to Leverage the Medical Devices Regulation (MDR) Whilst Supporting a Broad Innovative Portfolio in Pharma
    Daniel Latham, Novartis

    14:50 - 15:10
    Impact of MDR Article 117 on Marketing Authorization Applications for Pre-filled Syringes
    Stephanie Horn, F. Hoffmann-La Roche

    15:10 - 15:30
    MDR Article 117: Notified Body Opinion Interpretation and Implementation
    Blake Green, Amgen

    15:30 - 16:00
    Q&A, Discussion

    16:00 - 16:45
    Coffee Break, Poster Session & Exhibition

    Transition to Three Parallel Tracks

    16:45 - 18:00
    Session 2A: Large Volume Injection
    Moderator: Ian Thompson, Ypsomed

    16:45 - 17:05
    MRI Clinical Imaging of Human Subcutaneous Injections Up to 10ml in the Abdomen, Thigh and Arm
    Wendy D Woodley, Becton Dickinson

    17:05 - 17:25
    Evaluating Formulation and Device Factors on Subcutaneous Administration
    Rhea Sirkar, Eli Lilly

    17:25 - 17:45
    Evolving Component Technologies to Meet the Needs of Cartridge Delivery Applications
    Simon Cote & Royce C. Brockett, WEST

    17:45 - 18:00
    Q&A, Discussion

    16:45 - 18:00
    Session 2B: Manufacturing and Processing Technologies
    Moderators:
    Laurent Jeanmart,
    GSK
    Karthik Vaideeswaran, Eli Lilly

    16:45 - 17:05
    Innovations in Manufacturing of Elastomeric Components for Parenteral Packaging Applications
    Rahul Thakar, Datwyler Sealing Solutions

    17:05 - 17:25
    Augmented Reality for Preventive Maintenance
    Michael Pratz, Bausch & Stroebel

    17:25 - 17:45
    Vision Robot Unit (VRU)
    Michael Betz, F. Hoffmann-La Roche

    17:45 - 18:00
    Q&A, Discussion

    16:45 - 18:00
    Session 2C: Novel Therapeutics
    Moderator: Manfred Maeder, Novartis

    16:45 - 17:05
    Design Considerations Pertaining to Primary Container Used for Cell Therapy Products
    Min Wei, AstraZeneca

    17:05 - 17:25
    A Science-Based Recommendation of Elastomer Components for Biologic Drugs
    Cathy Zhao, WEST

    Challenges & Device Opportunities with Microliter Dose Delivery Using Standard Pre-fillable Syringes: A Case Study
    Gautam Shetty, Congruence Medical
    Kedar Datar, Boehringer Ingelheim

    17:45 - 18:00
    Q&A, Discussion

    18:00
    End of Day 1 & Networking Event

  • Wednesday, 23 October 2019

    9:00 - 10:45
    Morning Plenary
    Moderator: Mathias Romacker, Pfizer

    KEYNOTE PRESENTATIONS: Patient & Payers Perspectives

    9:00 - 9:25
    Patient Perspective of Managing Type 1 Diabetes in the Digital Age
    Johan Ahstrom, Patient Speaker

    9:25 - 9:50
    The Evolving Payer Perspective on Injection Treatment Devices: Balancing Costs, Convenience, Outcomes and More
    Robert S. Epstein, Epstein Health

    9:50 - 10:15
    Unsolved Mystery:
    How to Get Payers to Reward Injection Device Innovation Every Time

    John Alter, Pfizer

    10:15 - 10:45
    Panel Discussion:
    Partnering with Payers and Health Systems to Support Digital Innovation in Drug Delivery Devices

    Moderator: Max Cambras, LEK

    10:45 - 11:30
    Coffee Break, Poster Session & Exhibition

    Transition to Three Parallel Tracks

    11:30 - 12:45
    Session 3A: Connectivity - Smart Devices in Clinical Trials
    Moderator: Markus Bauss, SHL-Connect

    11:30 - 11:50
    Digital Health Application Development Within a Pharmaceutical Culture
    Gareth Hilton, AstraZeneca

    11:50 - 12:10
    A Behavioural Design Approach to Digital Health Solutions
    Gerainth Davies, F. Hoffmann-La Roche

    12:10 - 12:30
    To Connect or Not to Connect: When Should A Parenteral Device Go Connected?
    Paul Greenhalgh, TeamConsulting

    12:30 - 13:00
    Q&A, Discussion

    11:30 - 12:45
    Session 3B: Manufacturing and Processing Technologies
    Moderators:
    Theresa Bankston,
    BD
    Philippe Lauwers Terumo

    11:30 - 11:50
    Case Study:
    Modular Scalability & Flexibility in Device Assembly - From Early Stage to Full Scale Production

    Jens Schou Christensen, Stevanato Group

    11:50 - 12:10
    Modularizing Assembly and Testing Equipment for Auto and Pen Injectors
    Gilbert Fluetsch & Lucy Chung, SHL Group

    12:10 - 12:30
    Seeing the Hidden: Detection and Mechanistic Tests of Leakage in Pre-filled Syringe During Storage by Neutron Radiography
    Jonas Fransson, Swedish Orphan Biovitrum

    12:30 - 13:00
    Q&A, Discussion

    11:3 - 12:45
    Session 3C: Development Strategies
    Moderator: Brigitte Reutter-Haerle, Vetter Pharma

    11:30 - 11:50
    Collaboration to Enable a Simple, Reliable Device Suitable for Self-Administration in Early Clinical Studies Through to Commercialization
    Nicolas Bralet, Becton Dickinson
    Peter Krulevitch, Janssen

    11:50 - 12:10
    Creating a Parenteral Drug Delivery Device for Developing Markets – The Story of Allstar®
    Rob Vasey, DCA Design International
    Stefan Bohling, Sanofi Aventis

    12:10 - 12:30
    Software and Services to Transform Drugs into Disease Management Solutions
    Alexander Dahmani, QuiO Technologies

    12:30 - 13:00
    Q&A, Discussion

    13:00 - 14:30
    Lunch Break, Poster Session & Exhibition


    Demo Booths in the Exhibition Space

     

    14:30 - 16:30
    Closing Plenary - Keynotes
    Moderators:
    Karthik Vaideeswaran,
    Eli Lilly
    Thomas Schoenknecht, LONZA

    14.30 - 15:00
    Formulation and Device Lifecycle Management – The Role of Drug Delivery Devices in Improving Access to Medicines
    Beate Bittner, F. Hoffmann-La Roche

    15:00 - 15:30
    A Novel Approach to Characterizing Drug Delivery System Flow Performance
    Roman Mathaes, LONZA

    15:30 - 16:00
    Closing Panel Discussion, Q&A

    16:00 - 16:30
    Conference Summary by the 2019 Co-Chairs
    Thomas Schoenknecht, LONZA
    Mathias Romacker, Pfizer

    16:30
    Closing Comments & Farewell
    Falk Klar, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
  • 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

Early Registration
Registration Type Price by 25 August
Member €1.795
Non-member €2.095
Govern./Health Authority/Academic €800
Young Professional (Member) €800

All fees given in Euro, excluding VAT (25%)
Regular Registration
Registration Type Price after 25 August
Member €1.995
Non-member €2.295
Govern./Health Authority/Academic €1.000
Young Professional (Member) €1.000

All fees given in Euro, 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).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact [email protected] or +1 (301) 656-5900.

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
[email protected]

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