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

Gothenburg, Sweden
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Program Highlights

The agenda 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.

Note PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required.

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!

The Co-Chairs

Theresa Bankston, BD
Alessandro Morandotti, Stevanato Group


  • Theresa Bankston, BD
  • Alessandro Morandotti, Stevanato Group
  • Frank Bamberg, CSL Behring
  • Nicolas Brandes, WEST
  • Marion Briggs, HealthBeacon on behalf of Alliance to Zero
  • Bart Burgess, SHL Medical
  • Flora Felsovalyi, LONZA
  • 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

Standard Registration

Member Price


GovernmentMember Only


Health AuthorityMember Only


Early Career ProfessionalMember Only


AcademicMember Only




See Qualifying Criteria for Member Types.


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

Tuesday, 17 October 2023

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

09:15-12:40 I Opening Plenary: The Evolving Landscape of Patient-Centric Care
Moderator: Theresa Bankston, BD

Significant advances in injectable drug delivery have been made over the past 20 years, and rapid evolution aimed at improving patient experience, health outcomes, and total cost of care is expected to continue. This session will reflect on drivers and enablers for this evolution, challenges faced, the impact achieved, and expectations for the future. We will learn perspectives from a patient, drug manufacturer, device developer, and service provider on what it takes to develop, commercialize, and manage effective therapies, together. The audience can expect to hear highlights about market and healthcare ecosystem dynamics, the role and future of smart devices, how to incorporate patient insights, shared lessons learned, future opportunities, and more.

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

How Understanding Patient Behavior and Experience Can Assist in the Development and Optimization of Treatments – A Patient Perspective
Piet Christiaens, Nelson Lab

10:15 - 11:15 | Coffee Break, Poster Session & Exhibition, Tech Talks & Guided Poster Walk (Part I)

How Smart Devices are Impacting Delivery of Care and Improving Patient Experience
Ralph Camardelli, Sanofi
Eric Dessertenne, Biocorp

Interactive Questionnaire Session
Via Mentimeter

Panel Discussion

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

14:10-15:30 I Session 1A: Large Volume
Moderator: Frank Bamberg, CSL Behring

Large-volume injections are a challenge primarily for the patient. Device manufacturers and the pharmaceutical industry have taken on this challenge. Devices were adapted to the needs of the patients and the injection volume. Additives were developed so that the human body absorbs larger amounts better. In this event, solutions, and the ways to get there will be shown and discussed.

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

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

A Case Study: How Stakeholder Needs Guided the Collaborative Development of a Pre-Filled Syringe and an Autoinjector for Large-Volume Subcutaneous Drug Delivery
Sven Pohle, SCHOTT Pharma
Reto Jost, Ypsomed

Q&A, Discussion

14:10-15:30 I Session 1B: Digital Health and Smart Devices
Moderator: Jakob Lange, Ypsomed

The digital revolution is making its way into the injection device area. This session will provide examples of recent innovations and approaches to include behavioral science in the development of smart devices, how digital health can enable improved adherence tracking, and obtaining regulatory clearance for digital solutions in the injection space.

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

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

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

Q&A, Discussion

14:10-15:30 I Session 1C: Manufacturing
Moderator: Laurent Jeanmart, GSK Vaccines

Regarding manufacturing processes in constant evolution, this session will describe several case studies about track and trace solutions (RFID) and efficient collaboration for stability improvement for a combination product. Moreover, new Ready to Use (RTU) container aseptic practices in compliance with EU GMP Annex 1 will also be presented.

A Case Study in the Implementation of Radio Frequency Identification (RFID) -Enabled Pre-Filled Syringes on an Aseptic Fill and Finish Line
Herve Soukiassian, BD
Mario Schwab, 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
Andreas Kerschbaumer, Novartis
Manfred Holzer, SKAN

Synergistic Collaboration with Glass Syringe Manufacturer during Drug Product Lifecycle: A Case Study on Improved Stability for a Combination Product
Stefano Pilati, Stevanato Group
Andy Han, Bayer (remote presentation)

Q&A, Discussion

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

16:30-17:50 I Session 2A: Patient Interface
Moderator: Christian Helbig, SCHOTT Pharma

The pharma industry has increasingly adopted the mantra of “patient-centricity” which aims to put the patient at the heart of the consideration of the drug and device development process. In this session, we will present and discuss aspects of Human Factor practices in the context of Low-to-Middle-Income healthcare settings, early inclusive design approaches as well as patient insights on their sustainability expectations of drug delivery devices.

Inclusive Design in Medicine and Device Development
Dave Pearce and Chiko Ncube, GSK

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

Global Health: Deploying Human Factors Research Within Low-to-Middle-Income Countries
Alejandra Anderson & Timothy Quigg, Crux Product Design

Q&A, Discussion

16:30-17:50 I Session 2B: Development
Moderator: Shirish Ingawale, Takeda

Persistent innovation continues to drive evolution of treatment modalities and injection systems that strive to fulfil growing trends such as novel formulations, self-administration, less frequent dosing, etc. This session will focus on developing robust, reliable, and high-quality drug delivery devices and drug/device combination products. The speakers will discuss approaches to achieve highly desired and equally challenging traits – speed, optimal quality, and enhanced user experience – during the development of combination products through risk-based approach and control strategies.

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

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

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

Q&A, Discussion

16:30-17:50 I Session 2C: Regulatory
Moderator: Manfred Maeder, Novartis

During our regulatory session, we will hear about the most recent changes and expectations on the Medical Device Regulation (MDR) including the expectations on the GSPRs (General Safety and Performance Requirements) for medical devices and drug-device combinations. And we will learn more about the notified body opinion process and some case studies associated with that new requirement. Furthermore, there will be some evaluation and comparison of new HFE (Human Factors Engineering) requirements around the globe.

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

Article 117 Medical Device Regulation (MDR) - Notified Body Opinion: State of the Play and Lessons Learned
Christiana Hofmann, 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
Petra Boeree, Emergo by UL

Q&A, Discussion

17:50 | End of Conference Day 1 and Networking Event

Day 2

Wednesday, 18 October 2023

09:00-10:20 I Opening Plenary: Industry Partnerships for Sustainable Product Design and Recycling
Moderator: Akshay R. Kamdar, Eli Lilly and Company

This plenary session focuses on the importance of sustainability in the pharma/biotech industry. Key topics such as designing products with a patient and planet-centric mindset, addressing recycling challenges for medical devices with design guidance for end-of-life recycling, and exploring industry partnerships and collaborations for recycling will be highlighted.

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

Industry Collaboration for Device Sustainability
Paolo Mangiagalli, Sanofi

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

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

Panel Discussion

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

11:05-12:25 I Session 3A: Sustainability
Moderator: Marion Briggs, HealthBeacon on behalf of Alliance to Zero

This session will focus on the primary drivers and challenges when considering sustainable models within the industry. Our speakers will cover the critical factors influencing lifecycle assessments, digital solutions within sustainability, and how to leverage these processes to increase operational efficiency. Key highlights include real-world examples, strategies for implementation, and how to leverage lifecycle assessment data for a more sustainable future.

Carbon Footprint of Capital Good Gains Attention
Markus Winter, Harro Höfliger
Bernhard Gerl, Körber Pharma

EcoDesign Considerations and CO2 Reduction for Medical Devices
Glenn Svedberg, Nolato AB

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

Q&A, Discussion

11:05-12:25 I Session 3B: Innovation and Collaboration
Moderator: Philippe Lauwers, Terumo

Speed to market has become a differentiating factor for success in the pharma industry nowadays. To bring products to market quickly, pharma companies, device suppliers, and contract manufacturers must build strong and efficient partnerships and establish robust supply chain channels. In this session, we will provide valuable insights from all stakeholders and offer recommendations on how to accelerate development, foster seamless collaboration, and better meet customer needs.

From Drug Development to Final-Packaged Product: The Role of Strategic Partnerships in Streamlining On-Body Delivery Systems Manufacturing
Christian Riva, Stevanato Group
Chris Howell, 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
Tushar Patki, Biogen (remote presentation)
Nathan Kast, BD

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

Q&A, Discussion

11:05-12:25 I Session 3C: Drug Container Interaction
Moderator: Roman Mathaes, Clear Solutions

Join us for an insightful session on drug-device interaction. Our expert speakers will shed light on key topics such as visible particles in combination products, exploring their impact on drug stability and patient safety. We will also delve into new findings of silicone oil interaction with drug products, addressing potential risks and mitigation strategies. Additionally, our session will focus on the unique challenges encountered in developing pre-filled syringes for intravitreal injections.

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

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

Delivering a Superior Ophthalmic Pre-Filled Syringe (PFS) with Low Particles and Exceptional Human Factors
Chris Weikert, SIO2
Simon Lay, Cytiva

Q&A, Discussion

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

14:25-17:15 I Closing Plenary: Keynotes
Moderator: Alessandro Morandotti, Stevanato Group

Regulatory Compliance is key for the successful development of combination products. Fulfilling these requisites imply continues updated of the regulatory strategy. In this session, we will review and discuss the implication of the New EU GMP Annex 1 on the pre-filled syringes manufacturing and processing, and we will conclude with an overview of the emerging global policies to have a look at what is coming next.

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

Global Regulatory Policies Impacting Prefilled Syringes and Injection Devices
Rumi Young, BD (Former FDA-Regulator)

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

16:00 - 16:05 | Passport Raffle

Closing Panel Discussion

Join our Discussion with Experts from the Industry and Regulatory
  • Bart Burgess, SHL Medical
  • Stephen Fournier, CSL Behring
  • Manfred Maeder, Novartis
  • Daniel Müller, Local Inspectorate Tübingen
  • Karthik Vaideeswaran, Eli Lilly and Company
  • Rumi Young, BD (Former FDA-Regulator)

Co-Chairs 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

Agenda is subject to change.

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

PDA recommends the reservation at the following hotel

Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg,

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

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.