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2023 Universe of Pre-Filled Syringes

2023 PDA Universe of Pre-Filled Syringes and Injection Devices Conference

Oct 17 - Oct 18, 2023
Gothenburg, Sweden

20 Years of Innovation in Drug Delivery – What’s Next?

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  • Europe
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Program Highlights

The agenda preview is out now!

Take a look at our video clip to get an impression of our next edition.

Looking forward to seeing you in Gothenburg.

Overview

Dear Colleague,

The PDA and the Scientific Program Planning Committee cordially invite you to join us in person in Gothenburg, Sweden from 17-18 October 2023 for our 20th edition of the PDA Universe of Pre-Filled Syringes and Injection Devices Conference!

Since its inception, this conference has been a cornerstone for our industry to learn, share, debate, and collaborate, to face our common challenges, and to drive forward innovation in injectable drug delivery. In 2004, the conference made its humble debut in Europe with a focus on pre-filled syringes and an attendance of fewer than 100 people. Since then, the conference has expanded to the United States, grown tremendously in scope and attendance, and enabled the creation of various task forces that serve important missions in our industry. After 20 years, we remain reflective, proud of our purpose, and grateful for our collective achievements. Today, the PDA Universe of Pre-Filled Syringes and Injection Devices Conference is the perfect platform to present breakthrough innovations, help foster knowledge, and contribute to the wider pharmaceutical and medical device industries' shared purpose to improve global health.

This year, we are excited to return to the beautiful city of Gothenburg, Sweden, known for its culinary scene, friendly people, and seaside charm. In 2022, Gothenburg was ranked first by the Global Destination Sustainability Index for the seventh year in a row, making it not only a well-placed and culturally engaging location for our event but also a responsible one.

Consistent with our strong history, we are creating another exciting program focused on the most impactful and current topics of interest, such as the delivery of novel therapeutics, digital health, and sustainability. Our venue offers you the invaluable opportunity to expand your knowledge and identify new technologies, approaches, and business opportunities, and the program is designed to provide ample time for discovery in our vast expo hall and for networking with leading key opinion leaders, industry peers, service providers, and vendors.

We welcome you with open arms to join us, reconnect with your PDA family, and contribute to the world's leading event on this topic.

We look forward to seeing you there!

Sincerely,
The Co-Chairs

Theresa Bankston, BD
Alessandro Morandotti, Stevanato Group

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Theresa Bankston, BD
  • Alessandro Morandotti, Stevanato Group
  • Frank Bamberg, CSL Behring
  • Nicolas Brandes, WEST
  • Marion Briggs, Alliance to Zero on behalf of HealthBeacon
  • Flora Felsovalyi, Roche
  • Josh Gonzalez, SHL Medical
  • Christian Helbig, SCHOTT
  • Shirish Ingawale, Takeda
  • Laurent Jeanmart, GSK Vaccines
  • Akshay R. Kamdar, Eli Lilly and Company
  • Christian Kollecker, Harro Hoefliger
  • Jakob Lange, Ypsomed
  • Philippe Lauwers, Terumo
  • Manfred Maeder, Novartis
  • Roman Mathaes, Clear Solutions
  • Maggie Reiff, Genixus
  • Brigitte Reutter-Haerle, Vetter
  • Patrick Wieland, Bausch & Ströbel
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe
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Agenda

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  • Day 1
  • Day 2

  • Tuesday, 17 October 2023

    09:00 I Welcome and Introduction
    Falk Klar, PDA Europe
    Theresa Bankston, BD
    Alessandro Morandotti, Stevanato Group

    Opening Plenary: The Evolving Landscape of Patient-Centric Care
    Moderator: Theresa Bankston, BD

    The Inspiring Evolution of Parenteral Combination Products from 2004 to Today from an Entrepreneurial Perspective – And a Peek at What Is Coming
    Kymanox

    How Understanding Patient Behavior and Experience can assist in the Development and Optimization of Treatments – A Patient Perspective
    Nelson Lab

    10:05 - 11:05 | Coffee Break, Poster Session & Exhibition & Guided Poster Walk (Part I)

    How Smart Devices are Impacting Delivery of Care and Improving Patient Experience
    Sanofi & Biocorp

    Interactive Questionnaire Session
    Via Mentimeter

    Panel Discussion

    12:40 - 14:10 | Lunch Break, Poster Session & Exhibition & Tech Talks

    Session 1A: Large Volume
    Moderator: Frank Bamberg, CSL Behring

    Pre-Clinical Assessment of a High-Volume, High-Speed Prototype Auto-Injector to Subcutaneously Deliver a Polyclonal Antibody with Recombinant Human Hyaluronidase PH20 (rHuPH20)
    Halozyme Therapeutics

    Exploring US Payer Perspectives on Large-Volume Subcutaneous OnBody Delivery Systems: A Double-Blinded Preference Study
    Enable Injections, Inc

    A Case Study: How Stakeholder Needs to Guide the Collaborative Development of a Pre-Filled Syringe and an Autoinjector for Large-Volume Subcutaneous Drug Delivery
    SCHOTT Pharma & Ypsomed

    Q&A, Discussion

    Session 1B: Digital Health and Smart Devices
    Moderator: Jakob Lange, Ypsomed

    Next Generation Auto-Injectors: Leveraging the Power of a Digital Platform for Enhanced Adherence Tracking
    Merck KGaA

    Injecting Behavioral Science into Self-Administration Combination Products, Where Digital Meets Physical: Reflections, Challenges, and Observations
    AstraZeneca

    Regulatory Clearance for Implementation of a Digital Solution Supporting Use of an Autoinjector
    F. Hoffmann-La-Roche

    Q&A, Discussion

    Session 1C: Manufacturing
    Moderator: Laurent Jeanmart, GSK Vaccines

    A Case Study in the Implementation of Radio Frequency Identification (RFID) -enabled Pre-Filled Syringes on an Aseptic Fill and Finish Line
    BD & Optima

    Validatable Transfer Method for Ready to Use (RTU) Syringes and Vials into Grade A in Compliance with EU GMP Annex 1 including a Case Study
    Novartis & SKAN

    Synergistic Collaboration with Glass Syringe Manufacturer during Drug Product Lifecycle: A Case Study on Improved Stability for a Combination Product
    Nuova Ompi & Bayer

    Q&A, Discussion

    15:30 - 16:30 | Coffee Break, Poster Session & Exhibition + Guided Poster Walk (Part II) & Tech Talks

    Session 2A: Patient Interface
    Moderator: Christian Helbig, SCHOTT Pharma

    Inclusive Design in Medicine and Device Development
    GSK

    Patient Voices in Sustainable Drug Delivery: Insights on Self-Injection Devices
    Ypsomed

    Global Health: Deploying Human Factors Research Within Low-to-Middle-Income Countries
    Crux Product Design

    Q&A, Discussion

    Session 2B: Development
    Moderator: Shirish Ingawale, Takeda

    Combination Products Control Strategy– A Holistic Approach and Statistical Considerations
    Pfizer

    The Strategy of Accelerating Injectable Combination Product Development for Faster Clinical Entry and Market Access
    Merck Group

    Current Trends and Future Innovations in Autoinjectors for Large-Volume Subcutaneous Delivery: A Systematic Literature Review
    Ypsomed

    Q&A, Discussion

    Session 2C: Regulatory
    Moderator: Manfred Maeder, Novartis

    Update on Technical Report 73-2: Application of Medical Device Regulations, EU GMP Annex I Requirements (GSPRs) for Staked Needle Syringes
    West

    Article 117 Medical Device Regulation (MDR) - Notified Body Opinion: State of the Play and Lessons Learned
    Anteris Medical

    Are we Two of a Kind? Recent Regulatory Developments across the Globe, and how those might Impact Future European Human Factors Engineering Submissions
    Emergo by UL

    Q&A, Discussion
    17:50 | End of Conference Day 1 and Networking Event

  • Wednesday, 18 October 2023

    Opening Plenary:
    Moderator: Akshay R. Kamdar, Eli Lilly and Company

    HPRC Design Guidance: Enabling Recycling at End-of-Life
    Healthcare Plastics Recycling Council (HPRC)

    Addressing Recycling: One of the Bottlenecks of Circularity
    Eli Lilly and Company

    Industry Collaboration for Device Sustainability
    Sanofi

    Designing for Patients and the Planet: Circular Solutions for Pharmaceutical Products
    Johnson & Johnson

    Panel Discussion

    10:20 - 11:05 | Coffee Break, Poster Session & Exhibition & Tech Talks

    Session 3A: Sustainability
    Moderator: Maggie Reiff, Genixus

    Carbon Footprint of Capital Good Gains Attention
    Harro Höfliger & Körber Pharma

    EcoDesign Considerations and CO2 Reduction for Medical Devices
    Nolato AB

    A Parametric Model Developed from Activity-Based Footprinting to Simplify the Complexity of Lifecycle Assessment Towards Sustainable Autoinjector Devices
    SHL Medical

    Q&A, Discussion

    Session 3B: Innovation and Collaboration
    Moderator: Philippe Lauwers, Terumo

    From Drug Development to Final-Packaged Product: The Role of Strategic Partnerships in Streamlining On-Body Delivery Systems Manufacturing
    Stevanato Group & ThermoFisher

    Importance of Selection and Management of Appropriate Partnerships for Combination Product Development and Lifecycle Management – Perspectives from a Pharmaceutical Company and A Device Manufacturer
    Biogen & BD

    The Secret of Successful Partnerships between the Pharmaceutical Companies and Their Device Suppliers
    Merck & Co, Inc

    Q&A, Discussion

    Session 3C: Drug Container Interaction
    Moderator: Roman Mathaes, Clear Solutions

    Silicone Depletion in Combination Products Induced by Biologics
    Ludwig-Maximilians-Universität München

    Comprehensive Countermeasures to Reduce Proteinaceous Visible Particles in Liquid Monoclonal Antibody Products
    Chugai Pharmaceutical

    Delivering a Superior Ophthalmic Pre-Filled Syringe (PFS) with Low Particles and Exceptional Human Factors
    SIO2 & Cytiva

    Q&A, Discussion

    12:25 - 14:25 | Lunch Break, Poster Session & Exhibition & Tech Talks

    Closing Plenary: Keynotes
    Moderator: Alessandro Morandotti, Stevanato Group

    Manufacturing of Pre-Filled Syringes – The Impact of New EU GMP Annex 1
    Local Inspectorate Tübingen

    Title to be Announced
    U.S. FDA

    15:15 - 16:00 | Coffee Break, Poster Session & Exhibition

    16:00 - 16:05 | Passport Raffle

    Closing Panel Discussion

    Conference Summary
    Theresa Bankston, BD
    Alessandro Morandotti, Stevanato Group

    Closing Remarks & Farewell
    Falk Klar, PDA Europe

    17:15 | End of Conference

    The agenda is subject to change without notice, Speakers are invited, pending confirmation

Networking Opportunities

Since its inception, the PDA Universe of Pre-Filled Syringes and Injection Devices Conference has been a cornerstone for the industry to learn, share, debate, and collaborate, to face the common challenges, and to drive forward innovation in injectable drug delivery. The 20th edition of the PDA Universe of Pre-Filled Syringes and Injection Devices Conference is the perfect platform to present breakthrough innovations, help foster knowledge, and contribute to the wider pharmaceutical and medical device industries' shared purpose to improve global health. Additionally, the networking event will definitely be remembered: Light, Camera, Action - PDA goes Hollywood.

PDA Networking Hollywood Event

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

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
  • Accommodations

    PDA recommends the reservation at the following hotel

    Gothia Towers Hotel
    Mässans Gata 24
    41294 Gothenburg,
    Sweden

    PDA Europe has reserved a limited number of rooms until the 15th August 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

    For group requests over 6 bedrooms please send an email to [email protected]

    Attn. Emelie Sandell

  • Amenities

    Just a 20-minute walk from the hotel you will find The Garden Society of Gothenburg - one of Europe's best-preserved 19th-century parks. At the other end of town you will find the Botanical Garden, a world-class botanical garden with over 16,000 species to admire.

How to Get Here

By Air

Airport buses travel to and from Landvetter Airport (appox. 20 min. journey) stopping at Korsvägen/Svenska Mässan. They run directly between these stops.

By Car

E6 / E20 (from north) and road 45 (from Karlstad): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Take the first exit on the left, turn right onto Örgrytevägen and then take the next exit right towards Svenska Mässan. E6 / E20 (from south) and road 40 (from Borås): On arrival at Gothenburg, turn off at the sign “Mässan Scandinavium Liseberg”. Then take the second exit right towards the hotel.

Other Options

From the main railway station take the number 2 tram (towards Krokslätt) or the 4 (towards Mölndal). From Brunnsparken Square you can also take the number 5 tram (towards Torp). The trams stop at Korsvägen / Svenska Mässan. Tram timetables can be found on the Västtrafik website.

Directions

Registration Fees

Early Registration
Registration Type Price by 20 August
Member €2.195
Non-member €2.495
Govern./Health Authority/Academic €999
Early Career Professional (Member) €999







Regular Registration
Registration Type After 20 August
Member €2.395
Non-member €2.695
Govern./Health Authority/Academic €1.100
Early Career Professional (Member) €1.100







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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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10
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