PDA Parenteral Packaging Conference 2026

CEST Daylight Time (UTC +2:00)

• 09:00 – 09:05

  Welcome and Introduction

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association

• 09:05 – 09:15

  Welcome from the Co-Chairs

  • Co-Chair:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • Co-Chair:

    

    Bram Jongen, PhD
    Senior Vice President Materials and Surface Technologies, Datwyler

• 09:15 – 10:25

  Opening Plenary Part I

  • Moderator:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  Kick off the PDA Parenteral Packaging Conference 2026 with a forward-looking exploration of how regulatory expectations and market dynamics are reshaping primary packaging for parenteral products. Experts will unpack the latest global regulatory considerations, practical strategies for building robust specifications, and trends in parenteral packaging. This session sets the tone for a conference focused on innovation, compliance, and lifecycle excellence.

  • 09:15 – 09:40

    A Patient Perspective
  • 09:40 – 10:00

    Building Smart and Strong Specification for Primary Packaging: Practical Steps from Compliance to Lifecycle Success

    • Presenter:

      

      Federico Sabini, MD in Biomedical Engineering
      QC Senior Specialist Primary Packaging Materials and Combination Products, J&J

  • 10:00 – 10:25

    Title To Be Announced

    • Presenter:

      

      Graham Lewis
      

• 10:25 – 11:00

  LIVE Guided Poster Walk -Part I-

• 10:35 – 11:05

  Networking Coffee Break & Exhibition

• 11:05 – 12:35

  Opening Plenary Part II

  • Moderator:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • 11:05 – 11:25

    Recent Developments in European Pharmaceutical Packaging Chapters

    • Regulatory Presenter:

      

      Eugénie Maman
      Scientific Programme Manager, European Directorate for the Quality of Medicines & Healthcare (EDQM)

  • 11:25 – 11:45

    Regulatory Considerations for Container Closure System for Packaging

    • Regulatory Presenter:

      

      Madushini N Dharmasena, PhD
      Senior Pharmaceutical Quality Assessor, OPQ, CDER, U.S. FDA

  • 11:45 – 11:55

    Interactive Questionnaire Session
  • 11:55 – 12:35

    Plenary Discussion

    • Moderator:

      

      Coralie A. Richard, PhD
      Director, Eli Lilly and Company

• 12:35 – 13:50

  Networking Lunch Break, Poster Session, Exhibition & Tech Talks

• 13:50 – 15:10

  Session 1, Track A: The Science of Silicone: From Surface Coatings to Syringe Performance

  • Moderator:

    

    Philippe Lauwers
    Technology Development Director, Terumo Pharmaceutical Solutions

  Silicone plays a critical yet complex role in parenteral packaging, affecting both container surfaces and drug delivery performance. This session presents new insights into silicone layer behaviour and coating technologies, highlighting their impact on syringe functionality, product quality, and patient safety.

  • 13:50 – 14:15

    Investigating the Impact of Silicone Layer Properties on Intravitreal Syringe Performance: A Case Study

    • Presenter:

      

      Jari Acocella
      

  • 14:15 – 14:40

    Thermo-rheological Study of Silicone O/W Emulsions used in Surface Coating of Parenteral Containers

    • Academic Presenter:

      

      Damian Renggli
      

  • 14:40 – 15:10

    Q&A, Discussion

    • Moderator:

      

      Philippe Lauwers
      Technology Development Director, Terumo Pharmaceutical Solutions

• 13:50 – 15:10

  Session 1, Track B: Optimizing Packaging Quality

  • Moderator:

    

    Claudia Heinl, PhD
    Senior Product Manager & Scientific Affairs Pharma Tubing, SCHOTT AG

  Discover innovative approaches to container closure integrity (CCI) for injectable products. Learn how a breakthrough non-destructive method enables direct testing and explore case studies revealing why no single CCIT can address all failure modes, underscoring the need for a holistic strategy.

  • 13:50 – 14:15

    Direct CCI Testing of Fully Assembled Autoinjectors Using Headspace Analysis

    • Presenter:

      

      Paula Bracco, PhD
      R&D Lab Director (Europe), LIGHTHOUSE Instruments

  • 14:15 – 14:40

    (Not) Detecting Container Closure Integrity Failures – Some Case Studies

    • Presenter:

      

      Constantin Hozsa
      

  • 14:40 – 15:10

    Q&A, Discussion

    • Moderator:

      

      Claudia Heinl, PhD
      Senior Product Manager & Scientific Affairs Pharma Tubing, SCHOTT AG

• 15:10 – 15:50

  LIVE Guided Poster Walk -Part II-

• 15:20 – 15:55

  Networking Coffee Break & Exhibition

• 15:55 – 17:15

  Session 2, Track A: Material Science Driving Drug–Container Compatibility

  • Moderator:

    

    Jean-Sébastien Steffen, MS, PhD
    Group Lead Packaging Development Testing, Lonza

  Join leading experts to explore how material and packaging science principles can resolve compatibility challenges between drug products and their containers. This interactive session will provide practical insights and strategies to address common issues encountered in drug development and sterile manufacturing, helping participants improve reliability and compliance in daily operations.

  • 15:55 – 16:15

    Polymer Materials in the Pharmaceutical Packaging Industry in Terms of Durability as well as Chemical and Physical Resistance

    • Presenter:

      

      Ralf Lach, PhD
      CEO, Institut für Polymerwerkstoffe e.V.

  • 16:15 – 16:30

    Updates on ICH Q3E Guideline for Extractables and Leachables

    • Presenter:

      

      Will Parker, MS
      Data Analytics, Penn State University, USA

  • 16:30 – 16:45

    A Toolbox For Early Detection of Glass Delamination in Vials

    • Presenter:

      

      Farrokh Sharifi
      

  • 16:45 – 17:15

    Q&A, Discussion

    • Moderator:

      

      Jean-Sébastien Steffen, MS, PhD
      Group Lead Packaging Development Testing, Lonza

• 15:55 – 17:15

  Session 2, Track B: Challenges in Lyophilization and Parenteral Containers: Surface Interaction and Process Optimization

  • Moderator:

    

    Vincent Cazanave
    Regulatory Program Director / Device and Combination Product, Roche

  This session explores critical advancements and insights into the challenges of lyophilization and parenteral container systems, focusing on surface interactions and process optimization. The session will bring together expert to examine the complex interplay between container surfaces and lyophilized drug products, as well as practical strategies for optimizing processes to ensure product quality and performance.

  • 15:55 – 16:15

    Influence of Surface Energy and Chemistry on Glass Vial Fogging in Lyophilized Drug Products

    • Academic Presenter:

      

      Oliver Germershaus, PhD
      Professor for Pharmaceutical Technology of Macromolecular Drugs / Chief Scientific Officer, University of Applied Sciences and Arts Northwestern Switzerland / Partiris GmbH

  • 16:15 – 16:30

    Updates on PDA Technical Report 27- Pharmaceutical Packaging Integrity

    • Presenter:

      

      Jennifer Roark
      Scientific Director, Injectables, Kindeva

  • 16:30 – 16:45

    How Lyophilized Drug Product Appearance Can Be Impacted By Filling Recipe

    • Presenter:

      

      Mostafa Nakach
      

  • 16:45 – 17:15

    Q&A, Discussion

    • Moderator:

      

      Vincent Cazanave
      Regulatory Program Director / Device and Combination Product, Roche

• 17:15 – 22:00

  End of Conference Day 1 & Networking Event

CEST Daylight Time (UTC +2:00)

• 09:00 – 10:20

  Session 3, Track A: All About Transportation

  • Moderator:

    

    Max Dixon, MEng, PhD
    Lead Applied Sciences Engineer, Crux Product Design

  Discover how transport shapes packaging, sterility, and patient safety. Covering packaging standardization, regulatory challenges, extreme-condition testing, and distribution best practices, this session highlights data-driven strategies, insights from industry surveys, and international standards that safeguard component integrity and product quality across the supply chain - from manufacturing to patient delivery.

  • 09:00 – 09:10

    PDA Transportation Validation Benchmarking Survey

    • Presenter:

      

      Jahanvi Miller, MBA
      Head of Global Quality External Affairs, Baxter

  • 09:10 – 09:20

    Ensuring Component Integrity and System Performance Where It Matters Most

    • Presenter:

      

      Geert JAN Moens
      Global Platform Leader Vial Closure Systems, Datwyler

  • 09:20 – 09:30

    Requirements and Strategies for Transport & Distribution Testing of Medical Products

    • Presenter:

      

      Brandon Zurawlow
      

  • 09:30 – 09:40

    Unintended Plunger Stopper Movement of Finished Prefilled Syringes (PFS) at Variable Temperatures

    • Presenter:

      

      Charlotte Utting, MSc
      Laboratory Supervisor, Smithers Medical Device Testing Division

  • 09:40 – 10:20

    Q&A, Discussion

    • Moderator:

      

      Max Dixon, MEng, PhD
      Lead Applied Sciences Engineer, Crux Product Design

• 09:00 – 10:20

  Session 3, Track B: Sustainability

  • Moderator:

    

    Bettine Boltres, PhD
    Director Scientific Affairs, Integrated Systems, West Pharmaceutical Services

  Discover how our industry is reimagining sustainability - from circular design in and renewable polymers to regulatory alignment and low‑carbon cement. Learn how pioneers across the industry are transforming packaging and production to meet new regulations, reduce environmental impact, and unlock practical strategies you can apply to make your own operations smarter, greener, and future‑ready.

  • 09:00 – 09:10

    Borosilicate Glass, Cement: A Second Chance

    • Presenter:

      

      Stephen Whettingsteel, PhD
      CEO & Managing Director, Krysteline Technologies Ltd

  • 09:10 – 09:20

    Advancing Sustainability in Parenteral Elastomeric Closures Manufacturing

    • Presenter:

      

      Bruno Morchain
      Innovation & Scientific Affairs Manager, Aptar Pharma Injectables

  • 09:20 – 09:30

    Addressing the Requirements of the 2025/40 Packaging and Packaging Waste Regulation: Integrating Chemical Material Compliance in the Design of Safe and Sustainable Packaging

    • Presenter:

      

      Elmedina Shimaj, MA
      Regulatory Scientific Affairs and Liaison specialist, Stevanato Group, Nuova Ompi S.r.l Unipersonale

  • 09:30 – 09:40

    Eco-efficient Design - Strategies for Design for Recycling and Intermaterial Replacement

    • Presenter:

      

      Anja Gottschalk
      Application Development Engineer, Borealis GmbH

  • 09:40 – 10:20

    Q&A,Discussion

    • Moderator:

      

      Bettine Boltres, PhD
      Director Scientific Affairs, Integrated Systems, West Pharmaceutical Services

• 10:20 – 10:50

  Networking Coffee Break & Exhibition

• 10:50 – 12:10

  Session 4, Track A: Developing Drug Delivery Systems/Advanced Techniques

  • Moderator:

    

    Derek I. Duncan, PhD
    Director Product Lines, LIGHTHOUSE Instruments

  Today's innovative therapies often pose special requirements on the primary packaging and drug delivery systems to ensure product quality, stability, and patient safety. The presentations in this session give various examples of how optimized primary packaging designs can be an effective countermeasure to the risks of interactions between medical devices and pharmaceutical ingredients and illustrate the critical interplay between device design, formulation, and analytical expertise, as well as the use of predictive modeling and simulation tools.

  • 10:50 – 11:05

    A Guide to Generating Digital Evidence on Primary Containers Mechanical Testing

    • Presenter:

      

      Peter Harley, MEng, PhD, FIMechE
      Head of Technology, Crux Product Design

  • 11:05 – 11:20

    Leveraging Advanced Characterization Techniques in Drug and Device Combination Products: Enhancing Safety, Performance, and Stability

    • Presenter:

      

      Guangli Hu, PhD
      Principal Scientist, Merck & Co., Inc.

  • 11:20 – 11:35

    Challenges and Solutions of Primary Packaging in the Development of Antibody Drug Conjugates

    • Presenter:

      

      Bernhard Hladik, PhD
      Director Business Development, SCHOTT Pharma AG & Co. KGaA

  • 11:35 – 12:10

    Q&A, Discussion

    • Moderator:

      

      Derek I. Duncan, PhD
      Director Product Lines, LIGHTHOUSE Instruments

• 10:50 – 12:10

  Session 4, Track B: Ready-to-Use

  • Moderator:

    

    Matthew Hall, PhD
    Technical Affairs Director, Corning Pharmaceutical Technologies

  Increasing demands are being placed on sterilization methods and packaging systems as the pharmaceutical industry continues to develop increasingly complex drug products. This session explores critical advancements and challenges in the sterilization and validation of parenteral packaging, emphasizing innovative approaches to ensure product safety, packaging integrity, and regulatory compliance. Attendees will gain insights into cutting-edge sterilization technologies, including vaporized hydrogen peroxide under deep vacuum conditions, as an alternative to traditional methods like ethylene oxide. This approach not only meets stringent sterility assurance requirements but also safeguards the material integrity of ready-to-use (RTU) glass vials. Complementing this discussion is a deep dive into the validation challenges of a new RTU cartridge system, with a focus on seal integrity failures and sterile barrier reliability.

  • 10:50 – 11:05

    Rethinking Sterilization: Deep Vacuum vH₂O₂ as an Alternative to EtO for Glass RTF Vials

    • Presenter:

      

      Serena Carella
      Learning Campus Experience Director, Fedegari Autoclavi SpA

  • 11:05 – 11:20

    Beyond Bracketing: A Successful Partnership Case Study on Seal Integrity in RTU Primary Packaging

    • Co-Presenter:

      

      Lee Hyland
      Snr. Technical Services Engineer, Oliver Healthcare Packaging

    • Co-Presenter:

      

      Alessandro Girardi
      DCS Process Developer, Stevanato Group

  • 11:20 – 11:35

    Selecting the Proper Primary Container Closure Components for Drug Products Sensitive to Hydrogen Peroxide

    • Presenter:

      

      Eric Kurtz, MBA
      Manager, Technical Product Management, West Pharma

  • 11:35 – 12:10

    Q&A, Discussion

    • Moderator:

      

      Matthew Hall, PhD
      Technical Affairs Director, Corning Pharmaceutical Technologies

• 12:10 – 13:25

  Networking Lunch Break, Poster Session, Exhibition & Tech Talks

• 13:25 – 14:35

  Closing Plenary Part I

  • Moderator:

    

    Bram Jongen, PhD
    Senior Vice President Materials and Surface Technologies, Datwyler

  The world never stands still, and neither do we. Let’s conclude this year’s conference with two compelling keynote presentations, exploring how parenteral packaging continues to innovate for the benefit of both patients and the planet.

  • 13:25 – 13:50

    Making Sustainable Injectables Work: Drivers and Barriers to Adoption in Hospitals

    • Academic Presenter:

      

      Albena Bjoerck, PhD
      Associate Professor / Head of Global Business Lab, ZHAW School of Management and Law

    • Co-Presenter:

      

      Nadine K. Lampka, PhD
      Senior Product Manager Pharma-Security, Schreiner MediPharm

  • 13:50 – 14:10

    Emerging Regulations Impacting Packaging Operations

    • Presenter:

      

      Stephan K. Roenninger, Dr.-Ing.
      Director Compliance, External Affairs, Amgen (Europe) GmbH

  • 14:10 – 14:35

    Q&A, Discussion

    • Moderator:

      

      Bram Jongen, PhD
      Senior Vice President Materials and Surface Technologies, Datwyler

• 14:35 – 15:05

  Networking Coffee Break & Exhibition

• 15:05 – 15:10

  Passport Raffle

• 15:10 – 16:20

  Closing Plenary Part II

  • Moderator:

    

    Bram Jongen, PhD
    Senior Vice President Materials and Surface Technologies, Datwyler

  • 15:10 – 15:15

    Best Poster Presentation
  • 15:15 – 16:20

    Interactive Session
• 16:20 – 16:30

  Co-Chairs Conference Summary

  • Co-Chair:

    

    Coralie A. Richard, PhD
    Director, Eli Lilly and Company

  • Co-Chair:

    

    Bram Jongen, PhD
    Senior Vice President Materials and Surface Technologies, Datwyler

• 16:30 – 16:35

  Closing Remarks & Farewell

  • Committee Member:

    

    Falk Klar, PhD
    General Manager, Vice President Europe, Parenteral Drug Association