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2023 Parenteral Packaging

2023 PDA Parenteral Packaging Conference

Apr 18 - Apr 19, 2023
Lido di Venezia, Italy

Are You Ready? Incorporating Safety, User Centricities, and Sustainability into Packaging Innovation

  • Conference
  • Europe

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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.

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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

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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.

Agenda
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

Overview

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!
Sincerely,

The Chairs

Bettine Boltres, WEST
Derek Duncan, LIGHTHOUSE Instruments

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • 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

Agenda

  • Day 1
  • Day 2
  • Posters
  • Tuesday, 18 April 2023

    09:00

    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

    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
    Kurt Kugler, Schreiner Group 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

    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

    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

    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

    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

  • 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.

    • 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

    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

    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

    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

    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

    13:10 I Interactive Questionnaire Session

    13:25 I Decarbonizing Supply Chains in the Pharma Industry
    Bridget Ferrari, 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
    • Bridget Ferrari, 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

  • The following posters will be presented during the Guided Poster Walk on Day 1 at 13:35h and during each break in the Exhibit Hall

    CORRELATING STOPPER HEIGHT TO CONTAINER CLOSURE INTEGRITY
    Qianru Zuo, LIGHTHOUSE Instruments

    ENSURING CLOSURE INTEGRITY OF SYRINGES AT -80°C
    Apostolos Mangou,
    LIGHTHOUSE Instruments

    DYNAMICS OF PRESSURE DECAY LEAK TESTING OF PARENTERAL PRODUCTS
    Heinz Wolf, PTI INSPECTION SYSTEMS

    IS HIGH VOLTAGE LEAK DETECTION (HVLD) READY FOR ANNEX 1 AND USP1207?
    Virginia Turato,
    Stevanato Group

    BLISTER PACKAGING – QUO VADIS SUSTAINABILITY?
    Henning Föste, 
    Körber Pharma

    PARENTERAL DRUG PACKAGING´S IMPACT ON PATIENT SAFETY
    Katie Falcone,
    Datwyler

    HOW TO IMPROVE ENVIRONMENTAL FOOTPRINT OF DRUG DELIVERY SYSTEMS
    Hélène Vacelet,
    BD Medical - Pharmaceuticals Systems

    EBEAM TECHNOLOGY – TRANSFER TECHNOLOGY FOR PRE-STERILIZED RTU COMPONENTS
    Manfred Holzer,
    SKAN

    A SCIENTIFIC APPROACH TO EVALUATE THERMOPLASTIC ELASTOMERS (TPEs) FOR PRE-FILLED DRUG CONTAINERS: A CASE STUDY ON SYRINGE NEEDLE SHIELDS
    Eva Dieuzy, BD Medical - Pharmaceuticals Systems  


    EVOLVING COMPONENT TECHNOLOGIES TO MEET THE NEEDS OF LARGE VOLUME INJECTIONS

    Christa Janssen-Otten, West Pharma

    EFFECT OF ELASTOMER BASE AND COATING ON THE OF RUBBER EXTRACTABLES PROFILE
    Tine Hardemann,
    Datwyler

    LATEST HEADSPACE ANALYSIS APPLICATIONS TO SUPPORT REGULATORY REQUIREMENTS IN US AND EU
    Matthias Hiddemann, Wilco

    CELL AND GENE THERAPIES – CHALLENGES AND SOLUTIONS
    Ana Kuschel, West Pharma

Highlighted Speakers

Arne Kloke
Arne Kloke
SCHOTT
Valentina Petrusevska
Valentina Petrusevska
EDQM
Erika A. Pfeiler
Erika A. Pfeiler
U.S. FDA
Christian Proff
Christian Proff
F. Hoffmann-La Roche Ltd
Mihaela  Simianu
Mihaela Simianu
SmartSkin Technologies
Satish Singh
Satish Singh
Moderna
Stephen Whettingsteel
Stephen Whettingsteel
Krysteline Technologies
Matthias Winzer
Matthias Winzer
Merck KGaA

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.

Palazzo del Cinema (Venue)

Lungomare Marconi
Lido di Venezia, Italy

Make a Reservation
  • Accommodations

    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.

  • Amenities

    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”.

Other Options

From railway station Venezia Santa Lucia, the public service ACTV number 5.1 will take you from Venice Santa Lucia train station to Lido in about 40 minutes. If you want to pass through the Grand Canal you can catch line number 1 instead and the journey will take about 70 minutes. From railway station Venezia-Mestre, the public service ACTV with line 2 will lead you to Piazzale Roma in Venice.

Directions

Registration Fees

Early Registration
Registration Type Price by 19 February
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970











Regular Registration
Registration Type After 19 February
Member €2.245
Non-member €2.545
Govern./Health Authority/Academic €1.070
Early Career Professional (Member) €1.070











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.

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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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