2023 PDA Parenteral Packaging Conference

Lido di Venezia, Italy
Ask a Question Exhibitor Standard Contract Clause
Program Highlights

Join us in Lido di Venezia!

Check out an exciting program including talks not only from big pharma, vendors, and the EDQM but also from representatives of the U.S. FDA, and the Alliance to Zero.


Visit us at the Networking Event!

Tuesday, 18 April 2023
18:30h – 23:30h

PDA is proud to present to you a very special themed networking event "Venetian Night" with a boat tour to Canal Grande and dinner at the historical Palazzo Pisani Moretta. Dress code: Black tie optional



Check out our side event agenda for Early Career Professionals!

Wednesday, 19 April 2023
12:10h – 16:35h

PDA offers students and early career professionals (ECPs) a platform to arise questions to experts, get deeper insights and meet other students and ECPs to expand their network. Therefore, PDA has created a separate program item for this conference. On the second day of the conference, students and ECPs are invited to participate in a student session starting at lunchtime.

12:10h | Welcome and Introduction PDA
12:15h | Student Dedicated Session
13:10h | Guided Poster Walk
13:25h | Guided Exhibition Walk
14:05h | Coffee Break
14:40h | Join the Conference

If you would like to attend, please register with code 23_PDA-EU ParPack-ECP at [email protected]

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,

On behalf of the Scientific Program Planning Committee and PDA, we are proud to invite you to the 13th PDA Parenteral Packaging Conference to take place in Lido di Venezia, Italy, on 18-19 April 2023.

Undeniably, the world is shifting towards a more sustainable and resource-conscious way of acting. The pharmaceutical industry needs to follow this mind shift as well. And we do. Slowly but steadily, we see more and more initiatives coming up in different companies. Starting with the low-hanging fruits, such as outer packaging and logistics, we work our way into the core of our products, i.e. drug products including the primary packaging components.

At this conference we have distinguished speakers from the industry presenting their approach to sustainability and thus giving us inspiration for how we can start or move this forward in our own company.

However, as with all new topics, there are no real standards for working or measuring success. We are all trying to figure out our own way to contribute, which motivates why this conference is so important to attend. Only by interacting and exchanging ideas can we develop and define best industry practices for approaches to sustainability.

In addition to the conference theme, our core recurring topics of new technologies, materials, and techniques will also be addressed. Packaging development for parenteral preparations cannot be discussed as an isolated activity. Instead, a holistic and integrated approach considering the relevant development interfaces is inevitable. Drug-container interaction is a topic that always provokes new studies and discoveries.

This Conference has traditionally seen a strong mix of representatives from large pharmaceutical companies, packaging component vendors, leaders in manufacturing equipment, and regulatory experts. This enticing mix of delegates provides for a well-rounded conference agenda with top-notch presentations and interactive discussions around the complete pharmaceutical packaging value chain.

Join the PDA packaging community from all over the world and the involved parties, such as pharma companies, large and small, component suppliers, system suppliers, filling line vendors, analytical service providers, global regulators, and start-ups, just to name a few.

Ample exchange will be fostered during lunch and coffee breaks, interactive side events, and exciting evening networking activities. We see over and over again that a virtual meeting just cannot replace a good chat over a coffee or meal. And the location of Venice, Italy provides ample opportunity to refresh the mind with beautiful background scenery!

We are very much looking forward to meeting you once again at the 2023 PDA Parenteral Packaging Conference!

The Chairs

Bettine Boltres, WEST
Derek Duncan, LIGHTHOUSE Instruments


  • Bettine Boltres, WEST
  • Derek Duncan, LIGHTHOUSE Instruments
  • Ryan Forrey, BD
  • Sinue Gomez, Corning
  • Patricia Hughes, U.S. FDA
  • Bram Jongen, Datwyler
  • Arne Kloke, SCHOTT Pharma on behalf of Alliance to Zero
  • Ankur Kulshrestha, Bristol-Myers Squibb
  • Philippe Lauwers, Terumo
  • Coralie Richard, Eli Lilly and Company
  • Miho Soma, Gilead
  • Folker Steden, SCHOTT Pharma
  • 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, 18 April 2023


Welcome and Introduction
Falk Klar, PDA
Bettine Boltres, WEST
Derek Duncan, LIGHTHOUSE Instruments

09:15 - 12:50 I Opening Plenary: Where are we with Sustainability and how can we include it in Regulatory Developments?
Moderator: Bettine Boltres, WEST

We will start this conference with highlights from our conference theme and the regulatory world. We will discuss how we can even recycle glass containers that have already been contaminated, a challenge that has not yet been tackled. This is being complemented with updates and news from the U.S. FDA and the European Pharmacopeia.

09:15 I Keynote: The Global Problem of Pharmaceutical Glass Waste
Stephen Whettingsteel, Krysteline Technologies

09:40 I Having your Cake and Eating it too: Developmental Considerations for Preservative-Free Multidose Drug Products
Erika Pfeiler, U.S. FDA -remote presentation-

10:10 I Recent Developments in Ph. Eur. Packaging Chapters
Valentina Petrusevska, EDQM

10:40 - 11:10 | Coffee Break, Poster Session & Exhibition

11:10 I Towards Circular Packaging and Devices
Arne Kloke, SCHOTT Pharma on behalf of Alliance to Zero
Fritz Major, Harro Höfliger on behalf of Alliance to Zero

11:35 I Updates on Technical Report 73-2 (MDR GSPR Requirements for PFS)
Bettine Boltres, WEST

11:50 I Interactive Questionnaire Session

12:05 I Q&A, Panel Discussion

12:50 - 14:05 | Lunch Break, Exhibition & Interactive Poster Session

13:35 I Guided Poster Walk

14:05 - 15:25 | Concurrent Sessions

14:05 - 15:25 I Session 1 Track A: Insights from Container Closure System Development
Moderator: Philippe Lauwers, Terumo

In this session, we will present a case study detailing the development strategy of a cartridge packaging system for a micro-suspension, as well as a case study presenting advanced testing technologies and how they help to better estimate the risk of excessive injection forces during formulation refinement.

14:05 I Impact of Terminal Sterilization on Cartridge Packaging System Development for Suspensions
Dominick DeGrazio, GSK

14:30 I Leveraging the Relationship between Viscosity and Injection Force to Optimize Development Cost and Timeline
Jean-Sebastien Steffen, LONZA

14:55 I Q&A, Discussion

14:05 - 15:25 I Session 1 Track B: Container Closure Integrity Testing (CCIT) Part I 
Moderator: Miho Soma, Gilead

In this session, we will explore the application of new technologies and innovative approaches to ensure CCI for next-generation products, such as frozen-stored mRNA-based vaccines filled in vials or pre-filled syringes.

14:05 I Unlocking New Paths to Container Closure Integrity Assurance Realization
Mihaela Simianu, SmartSkin Technologies
Michael Edey, Pfizer

14:30 I Container Integrity in the Time of Covid-19
Satish Singh, Moderna-remote presentation-

14:55 I Q&A, Discussion

15:25 - 15:55 | Coffee Break, Poster Session & Exhibition

15:55 - 17:15 | Concurrent Sessions

15:55 - 17:15 I Session 2 Track A: Closed System Transfer Devices (CSTD)
Moderator: Derek Duncan, LIGHTHOUSE Instruments

This session will highlight the risks associated with the interconnection of CSTDs and propose design specifications and practical strategies to reduce these risks when developing new container closure systems and drug products.

15:55 I Comprehensive Risk Assessment and Development of Design Specifications for the Interconnection of Closed System Drug Transfer Devices and Vial Container Closure Systems
Pete Sargent, PQRI Group

16:20 I Strategies for De-risking of Clinical CSTD use during Chemistry, Manufacturing, Control (CMC) Development
Matthias Winzer, Merck KGaA

16:45 I Q&A, Discussion

15:55 - 17:15 I Session 2 Track B: Packaging Material Interactions and Defect Evaluation
Moderator: Sinue Gomez, Corning

Join us for an exciting discussion on extractable interactions of packaging with alternative sterilization techniques and challenges to determine equivalency. In this session, you will also hear about the creation of a comprehensive defect library for Blow-Fill-Seal (BFS) containers.

15:55 I Extractables Evaluation X-Ray or Gamma Irradiated SU Devices and Materials
Ina Pahl, Sartorius

16:20 I Defect Library of Blow-Fill-Seal Containers
Heino Prinz, Rommelag

16:45 I Q&A, Discussion

17:15 |End of Conference Day 1 and Networking Event

Day 2

Wednesday, 19 April 2023

08:00 | Workshop Morning Sessions

08:00 - 08:45 | Concurrent Sessions

08:00 - 08:45 I Track A: Packaging Science Workshop
Moderator: Derek Duncan, LIGHTHOUSE Instruments

This Interest Group will be meeting for discussion and current hot topics include among other things:

  • Implementation of EU GMP Annex 1 requirements for container closure
  • Primary packaging solutions for therapies needing ultracold storage and transport
  • Packaging and sustainability
  • Closed system transfer devices
  • Please join us for interaction and discussion!

08:00 - 08:45 I Track B: Pre-Filled Syringes Workshop
Moderator: Brigitte Reutter-Härle, Vetter

Take advantage of the open forum offered by this focused Interest Group workshop.

  • Listen to Mario Schwab, Optima presenting about 'Fill & Finish and the Challenges of New Packaging Technologies'
  • Discuss the latest market trends and industry topics with colleagues
  • Receive the latest information about activities of this Interest Group
  • Review and discuss the latest results from the previous polling
  • Share your opinion and enlarge your knowledge
  • Looking forward to a great session and discussion!

09:00 - 10:20 | Concurrent Sessions

09:00 - 10:20 I Session 3 Track A: Deep Cold Storage
Moderator: Patricia Hughes, U.S. FDA

This session will present case studies relating to container closure integrity failures due to deep cold storage conditions and will discuss the underlining causes of failures. Case studies will cover both vial and pre-filled syringe presentations.

09:00 I Container Closure Integrity Phenomenology and Failure Mechanisms during Deep Cold Storage
Eloïse Perrin, BD

09:25 I Vials for Deep Cold Storage
Diana Löber, SCHOTT Pharma

09:50 I Q&A, Discussion

09:00 - 10:20 I Session 3 Track B: Tackling Challenges in Large-Volume Containers
Moderator: Bram Jongen, Datwyler

Large-volume containers will be more prominent in the future parenteral packaging landscape. Let's tackle together with key experts’ specific challenges and smart solutions.

09:00 I Flexible Container Closure Systems: Unique Opportunities and Challenges
Sharath Gopal and David Pehlman, Eli Lilly and Company

09:25 I Container Closure Integrity Testing of Large Volume Containers
Jean-Sebastien Steffen and Federico Sabini, LONZA

09:50 I Q&A, Discussion

10:20 - 10:50 | Coffee Break, Poster Session & Exhibition

10:50 - 12:10 | Concurrent Sessions

10:50 - 12:10 I Session 4 Track A: Container Closure Integrity Testing (CCIT) Part II
Moderator: Coralie Richard, Eli Lilly and Company

When asked “What is the best strategy to build a CCI program”, the typical answer is always “it depends!”. Please join this session to get insights on container closure integrity techniques, their comparison, and their applicability through case studies that will help inform your container closure integrity strategy journey.

10:50 I Correlating CCI Leak Rates as Determined by Helium Leak Testing and Laser-Based Headspace Carbon Dioxide Analysis Using Modular Positive Controls
Christian Proff, F. Hoffmann - La Roche

11:15 I Strategies to Evaluate Container Closure Integrity (CCI) of Vial and Syringe Systems over Time and Temperature
Amy Gindhart, WEST

11:40 I Q&A, Discussion

10:50 - 12:10 I Session 4 Track B: Insights from Process Experts
Moderator: Folker Steden, SCHOTT Pharma

Are you interested in deep knowledge about aspects of modern process management of remote terminal unit injection moldings during sterilization, or how to handle characterizations of container closure integrity and maximum allowable leakage limit limits during large-scale freezing/thawing techniques? Listen to inspiring speeches about best practices and get exclusive insights. Looking forward to a good discussion afterward.

10:50 I Exploring the Impact of Injection Molding and Steam Sterilization on Pre-Fillable Cartridge Packaging System Tolerances
Marco Longhin, Stevanato Group
Peter Harley, Crux Product Design

11:15 I Large-Scale Freezing and Thawing of Biologics in Drug Substance Bottles
Sarah Peláez, ten23 health

11:40 I Q&A, Discussion

12:10 - 13:10 | Lunch Break, Poster Session & Exhibition

13:10 - 16:35 I Closing Plenary: Sustainable Packaging Now and in the Future
Moderator: Arne Kloke, SCHOTT Pharma on behalf of Alliance to Zero

We all want to have sustainable operations and products. But HOW? is the question we can insufficiently answer for our industry today. We’ll close the conference with a forum exchange on related challenges and solutions approaches that might fuel this transformation. We’ll bring together different perspectives – from component suppliers to pharmaceutical companies and from primary packaging and sterile barrier materials to packaging of the final product.

13:10 I Interactive Questionnaire Session

13:25 I Decarbonizing Supply Chains in the Pharma Industry
Sophie Azevedo, Takeda

13:40 I Sustainable Secondary Packaging in Pharma
Claudia Langjahr and Volker Grouls, Körber Pharma

14:05 - 14:35 | Coffee Break, Poster Session & Exhibition

14:40 I The Correlation Between Continuity, Supply Chain Resiliency, and Sustainability in Healthcare Packaging
Kiley Djupstrom, Kilmer Innovations
Jenn Goff, Oliver Healthcare Packaging

15:05 I Product Design and Life Cycle Analysis of Sustainable Pharmaceutical Containers
Shivani Polasani, Corning

15:30 I Closing Panel Discussion
Join our Discussion with Experts from the Industry

  • Kiley Djupstrom, Kilmer Innovations
  • Sophie Azevedo, Takeda
  • Jennifer Goff, Oliver Healthcare Packaging
  • Volker Grouls, Körber Pharma
  • Claudia Langjahr, Körber Pharma
  • Shivani Polasani, Corning

16:10 I Chairs Conference Summary
Bettine Boltres, WEST
Derek Duncan, LIGHTHOUSE Instruments

16:30 I Closing Remarks & Farewell
Falk Klar, PDA Europe

16:35 | 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.

PDA recommends a variety of hotels close to the conference location Palazzo del Cinema.

Under the link you can see the distances from the recommended hotels to the conference location.

Book your room at the PDA Group Rate via the above-mentioned reservation button until the 03 March 2023.

You can reach the Palazzo del Cinema from Piazzale Santa Maria Elisabetta with Line CO, Line CA and Line V stop at “Lion’s Bar”.

Getting around the Lido by bike is the easiest way to discover every part of the island. In several shops you can rent bicycles and rickshaws to move around also with friends on the Lido.

How to Get Here
By Air MARCO POLO AIRPORT - Shuttle Bus ATVO provides a Shuttle bus service departing from Venice Airport to Venice – Piazzale Roma approximately every hour. Once in Piazzale Roma, you can reach Venice Lido with ACTV public service: line number 6 will take you to Lido in about 30 minutes, otherwise you can catch the line number 5.1 that takes 40 minutes. If you want to pass through the Grand Canal and admire its magnificent palaces, you can catch line number 1: the journey is about 70 minutes. Alilaguna provides a boat service connecting Venice airport to Venice Lido in just 50 minutes.
By Car There are a number of car parking places where you can park your car like Venice Park, AutoPark Doge, and Garage San Marco. You can reach the Palazzo del Cinema from Piazzale Santa Maria Elisabetta with Line CO, Line CA and Line V stop at “Lion’s Bar”.