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2023 PDA Parenteral Packaging Conference
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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
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
If you would like to attend, please register with code 23_PDA-EU ParPack-ECP at [email protected]
Agenda
Discover What's Happening Each Day
Tuesday, 18 April 2023
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09:00 Welcome and Introduction |
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09:15 - 12:50 I Opening Plenary: Where are we with Sustainability and how can we include it in Regulatory Developments? 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. |
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09:15 I Keynote: The Global Problem of Pharmaceutical Glass Waste |
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09:40 I Having your Cake and Eating it too: Developmental Considerations for Preservative-Free Multidose Drug Products 10:10 I Recent Developments in Ph. Eur. Packaging Chapters |
10:40 - 11:10 | Coffee Break, Poster Session & Exhibition
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11:10 I Towards Circular Packaging and Devices 11:35 I Updates on Technical Report 73-2 (MDR GSPR Requirements for PFS) 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
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14:05 - 15:25 I Session 1 Track A: Insights from Container Closure System Development 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. |
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14:05 I Impact of Terminal Sterilization on Cartridge Packaging System Development for Suspensions 14:30 I Leveraging the Relationship between Viscosity and Injection Force to Optimize Development Cost and Timeline 14:55 I Q&A, Discussion |
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14:05 - 15:25 I Session 1 Track B: Container Closure Integrity Testing (CCIT) Part I 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. |
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14:05 I Unlocking New Paths to Container Closure Integrity Assurance Realization 14:30 I Container Integrity in the Time of Covid-19 14:55 I Q&A, Discussion |
15:25 - 15:55 | Coffee Break, Poster Session & Exhibition
15:55 - 17:15 | Concurrent Sessions
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15:55 - 17:15 I Session 2 Track A: Closed System Transfer Devices (CSTD) 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. |
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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 16:20 I Strategies for De-risking of Clinical CSTD use during Chemistry, Manufacturing, Control (CMC) Development 16:45 I Q&A, Discussion |
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15:55 - 17:15 I Session 2 Track B: Packaging Material Interactions and Defect Evaluation 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. |
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15:55 I Extractables Evaluation X-Ray or Gamma Irradiated SU Devices and Materials 16:20 I Defect Library of Blow-Fill-Seal Containers 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 This Interest Group will be meeting for discussion and current hot topics include among other things:
Please join us for interaction and discussion! |
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08:00 - 08:45 I Track B: Pre-Filled Syringes Workshop Take advantage of the open forum offered by this focused Interest Group workshop.
Looking forward to a great session and discussion! |
09:00 - 10:20 | Concurrent Sessions
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09:00 - 10:20 I Session 3 Track A: Deep Cold Storage 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. |
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09:00 I Container Closure Integrity Phenomenology and Failure Mechanisms during Deep Cold Storage 09:25 I Vials for Deep Cold Storage 09:50 I Q&A, Discussion |
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09:00 - 10:20 I Session 3 Track B: Tackling Challenges in Large-Volume Containers 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. |
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09:00 I Flexible Container Closure Systems: Unique Opportunities and Challenges 09:25 I Container Closure Integrity Testing of Large Volume Containers 09:50 I Q&A, Discussion |
10:20 - 10:50 | Coffee Break, Poster Session & Exhibition
10:50 - 12:10 | Concurrent Sessions
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10:50 - 12:10 I Session 4 Track A: Container Closure Integrity Testing (CCIT) Part II 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. |
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10:50 I Correlating CCI Leak Rates as Determined by Helium Leak Testing and Laser-Based Headspace Carbon Dioxide Analysis Using Modular Positive Controls 11:15 I Strategies to Evaluate Container Closure Integrity (CCI) of Vial and Syringe Systems over Time and Temperature 11:40 I Q&A, Discussion |
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10:50 - 12:10 I Session 4 Track B: Insights from Process Experts 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. |
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10:50 I Exploring the Impact of Injection Molding and Steam Sterilization on Pre-Fillable Cartridge Packaging System Tolerances 11:15 I Large-Scale Freezing and Thawing of Biologics in Drug Substance Bottles 11:40 I Q&A, Discussion |
12:10 - 13:10 | Lunch Break, Poster Session & Exhibition
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13:10 - 16:35 I Closing Plenary: Sustainable Packaging Now and in the Future 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. |
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13:10 I Interactive Questionnaire Session 13:25 I Decarbonizing Supply Chains in the Pharma Industry 13:40 I Sustainable Secondary Packaging in Pharma |
14:05 - 14:35 | Coffee Break, Poster Session & Exhibition
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14:40 I The Correlation Between Continuity, Supply Chain Resiliency, and Sustainability in Healthcare Packaging 15:05 I Product Design and Life Cycle Analysis of Sustainable Pharmaceutical Containers 15:30 I Closing Panel Discussion
16:10 I Chairs Conference Summary 16:30 I Closing Remarks & Farewell |
16:35 | End of Conference
The agenda is subject to change without notice, Speakers are invited, pending confirmation
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Venue Details and Accommodations
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
Registration
Pricing Options
Standard Registration
Member Price
€2.245GovernmentMember Only
€1.070
Health AuthorityMember Only
€1.070
Early Career ProfessionalMember Only
€1.070
AcademicMember Only
€1.070
Non-Member
€2.545
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
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.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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