2021 PDA Parenteral Packaging Conference
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Program Highlights
The 2021 conference will take place as an Online Event offering remote participation on a virtual platform. Various interactive options ensure an engaging and full conference experience! We look forward to seeing you online!
Check out the Final Agenda now!
Dear Colleagues,
On behalf of the Scientific Program Planning Committee and PDA Europe, we are proud to present the 11th Parenteral Packaging Conference, to take on 27-28 April 2021!
This conference has become highly regarded for its content and quality, and this year’s edition will continue the series of exceptional presentations and discussions. Industry leaders and technical experts from pharma and supplier companies along with regulators will cover many aspects of the drug -package interface.
Primary packaging of a parenteral pharmaceutical drug product should be designed, processed and manufactured, to ensure efficacy and safety of the patients. In particular, biopharmaceuticals require special considerations for aseptic processing and packaging.
Developments in packaging materials such as innovations in glass and polymer, and their characteristics regarding interactions with the drug product formulation and end-user preferences will be discussed. Case studies of the implementation of new guidelines, for example Annex 1 of the European GMP Guideline and USP 800 along with some of the latest developments in packaging materials & components and the role of Container Closure Integrity (CCI) in product-package development, assembly and processing will be presented. Low temperature storage of biopharmaceuticals for cell and gene therapy poses new challenges to packaging materials. Two way interactions of drug product/substance and container closures and their impact on drug stability, container functionality and device performance will be discussed.
The conference program is intended to initiate and support discussion and professional exchange through a diversity of scientific podium and poster presentations, live Q&As, and virtual networking events.
We look forward to you joining us once again!
Sincerely,
The Chairs
Roman Mathaes, PhD, LONZA
Galen Shi, PhD, Eli Lilly & Company
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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.
Day 1
Tuesday, 27 April 2021
Module I: Welcome & Opening: Regulatory Updates
12:00 - 13:45 CEST
| 11:00 - 12:00 Conference Portal Opens: Create your User Profile & Get Oriented & Join the Virtual Exhibition |
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| Welcome & Introductions | Falk Klar, PDA Europe |
| Welcome from the Chairs | Roman Mathaes, LONZA Galen Shi, Eli Lilly & Company |
| Keynote: COVID 19: Managing Drug Shortages and the Impact on Patients | Michael Ganio, ASHP |
| Regulatory Updates LIVE Session Introduction Hear the latest update of regulatory landscape around the globe. |
Moderators: Roman Mathaes, LONZA Galen Shi, Eli Lilly & Company |
| Recent CNPPA Guidance and Technical Documents Related to Pharmaceutical Packaging | Yonghua Gao, CNNPA |
| Applying the recent CDER – CBER COVID-19 Container Closure System Guidance: Glass Vials and Stoppers | Donald Klein, DNK Consulting |
| Introduction of PDA Standards & Recent PDA Activities | Bettine Boltres, WEST |
| LIVE Q&A, Discussion | |
Break & Virtual Exhibition
13:45 - 14:45 CEST
Module II: Closed System Transfer Devices & Container Closure at Deep Cold Storage
14:45 - 16:05 CEST
| Transition to Parallel Tracks | |||
| Track A - Closed System Transfer Devices | Track B - Container Closure at Deep Cold Storage | ||
| Moderators: Bettine Boltres, WEST Ankur Kulshretha, BMS |
Moderators: Derek Duncan, LIGHTHOUSE Roger Asselta, Genesis Packaging Technologies |
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| LIVE Session Introduction Continuing our eye-opening session from last year, where we discovered that the whole industry faces the same challenges in ensuring safety, efficacy, compatibility, and patient usability, we invite you to again share your experiences and ideas for improvement. Only by collaboration of all parties involved we can make a change! |
LIVE Session Introduction One of the topics brought to the forefront by the COVID-19 pandemic is deep cold storage and transport, a topic that will remain critical moving forward especially in the area of cell and gene therapy. This session addresses the challenges primary packaging systems have to maintain good container closure integrity at these deep cold storage temperatures. |
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| Vial/CSTD Compatibility Strategies for USP Implementation | Cathy Zhao and Fran De Grazio, West |
Container Closure Systems for Cell & Gene Therapy | Roman Mathaes and Federico Sabini, LONZA |
| Risk Based Customer Centric Approach to Development of Biologics Compatible with Closed System Transfer Devices | Alpa Bhattacharyya, BMS | Cold Storage Container Closure Integrity of Vial Primary Packaging Systems | Yusuf Oni, BMS |
| Closed System Transfer Devices, Causal Factors and Corrective Actions to Reduce Fragmentation/Coring | Joachim Pfeifer, Amgen | Selection of a Primary Container Closure System Capable of Maintaining Closure Integrity During Deep Cold Storage | Jennifer Riter, West Sinue Gomez, Corning |
| LIVE Q&A, Discussion | LIVE Q&A, Discussion | ||
Break & Virtual Exhibition
16:05 - 17:00 CEST
Module III: Automation in Secondary Packaging & Controlling Defects in Primary Packaging
17:00 - 18:00 CEST
| Automation in Secondary Packaging | Controlling Defects in Primary Packaging | ||
| Moderators: Roger Asselta, Genesis Packaging Technologies Philippe Lauwers, Terumo |
Moderators: Renaud Janssen, Datwyler Robert Guidos, Corning |
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| LIVE Session Introduction Automation continues to bring benefits to all areas of the pharmaceutical industry. In this session, you will hear how full traceability, digitalization and new approaches to inspection & packaging can support adherence to regulatory requirements, timely delivery of product and ultimately more patient safety. |
LIVE Session Introduction Packaging is there to protect the identity, strength, purity, quality and safety of drug products. For that reason, it is essential that defects in packaging components are controlled and that defects in container/closure systems are detected. In this session two distinguished speakers present on how they contribute to the highest drug product quality. |
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| Medical Device Tracking and UDI Serialization | Georg Schick, Uhlmann |
Particle control in the Production of ready-to-use primary packaging | Volker Rupertus, SCHOTT |
| New Requirements of the Inspection & Packaging Process for Small Batch Sized Medicines | Felix Riehn and Manuel Huber, Koerber Pharma |
Automatic Methods to Release Defect Free Parenteral Containers | Gianmarco Pincelli, Bonfiglioli Engineering |
| LIVE Q&A, Discussion | LIVE Q&A, Discussion | ||
Join our Virtual Networking Lounges
18:00 - 19:00 CEST
1) Poster Lounges: Live Discussion with the Poster Presenters
2) Handling Shortages During an Emergency Situation
3) Exchange on Regulatory Framework and Compatibility Issues with Drugs and Components
Day 2
Wednesday, 28 April 2021
Module IV: Glass & Impact of Packaging Components on Biopharmaceuticals
12:00 – 13:15 CEST
| 11:00 Conference Portal Opens: Create your User Profile, Get Oriented and Join the Virtual Exhibition |
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| Track A Glass |
Track B Impact of Packaging Components on Biopharmaceuticals |
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| Moderators: Folker Steden, SCHOTT Jörg Zürcher, Bayer |
Moderators: Philippe Lauwers, Terumo Roman Mathaes, LONZA |
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| LIVE Session Introduction Hear the latest research on minimizing vial damage during production and techniques for measuring leachables. |
LIVE Session Introduction This session will address various aspects regarding potential influences from primary packaging components and materials on drug quality, safety and efficacy, including the influence of surfactants, lubricants, container surface treatments and such more. |
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| Assessment of Vial Glass Damage During Cap Crimping Process | Roger Asselta, Genesis Packaging Technologies James E. Webb, Corning Alicia Gallagher, Corning |
Engineered Surfaces to Improve Storage and Delivery of Biologic Pharmaceuticals | Buddy Ratner, University of Washington |
| Determination of ICH-Q3D Elemental Impurity Leachables in Glass Vials by Inductively Coupled Plasma-Mass Spectrometry | Lydia Breckenridge, BMS | Considerations for Polysorbate Degradation and Particle Formation in Surfactant-containing Protein Formulations | Inn Yuk, Genentech/Roche |
| A New CDR Method Provides Leading Indicator of Delamination Risk | Dan Kramer, Corning | Modeling Liquid Flows in Auto-injectors |
Arezoo Ardekani, Perdue University |
| LIVE Q&A, Discussion | LIVE Q&A, Discussion | ||
Break & Virtual Exhibition
13:15 – 14:15 CEST
Module V: Sustainability & Considerations on Silicone Oil in Demanding Applications
14:15 – 15:10 CEST
| Track A Sustainability |
Track B Considerations on Silicone Oil in Demanding Applications |
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| Moderators: Folker Steden, SCHOTT Derek Duncan, LIGHTHOUSE |
Moderators: Robert Ovadia, Gilead Galen Shi, Eli Lilly & Company |
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| LIVE Session Introduction Learn about the recent efforts of the industry to advance sustainable manufacturing and waste management. |
LIVE Session Introduction Come join us as we continue to understand the interactions between silicone oil, drug product formulations, and pre-filled syringes. Learn how we can better design our formulations, processes, and instructions for health care providers to enable a safe and efficacious product. |
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| Sustainable Packaging in Merck Healthcare Supply Chain | Corinne Ondo, Merck KGaA - Healthcare | Silicone Oil / Drug Product Interactions in Pre-Filled Syringes: from Fundamental Understanding to Application in Surfactant Selection | Coralie Richard & Ting Ting Wang, Eli Lilly & Company |
| State of Biopharma Recycling – What Has Been Done and What Can be Done in Different Global Regions and What is on the Horizon | Jacqueline Hollands, MilliporeSigma – Merck KGaA -Life Science | Release of Silicone Oil from Syringes: Clinical Implications in Ophthalmology | Gustavo Barreto de Melo, Federal University of São Paulo |
| LIVE Q&A, Discussion | LIVE Q&A, Discussion | ||
Break & Virtual Exhibition
15:10 – 15:45 CEST
Module VI: Closing Plenary: Fast Tracking Time-to-Market with Innovation
15:45 – 18:00 CET
| Transition to Plenary | |
| Closing Plenary: Fast Tracking Time-to-Market with Innovation LIVE Session Introduction What have we learned from the triumph of COVID vaccine development in terms of rapid packaging development/manufacture? Can we apply the learnings to future parenteral products? |
Moderators: Galen Shi, Eli Lilly & Company Roman Mathaes, LONZA |
| Interactive Attendee Questionnaire on Fast Tracking Time-to-Market with Innovation | |
| Panel Discussion: Managing the Packaging Supply Chain in an Emergency Situation Join the live discussion with our expert panel and moderated by the Conference Chairs on raw materials, container supply, capacities of machines for container manufactures and fill & finish and efficient logistics during the ongoing pandemic. Moderators: Galen Shi, Eli Lilly & Company Roman Mathaes, LONZA Panelists: Guido Dietrich, CEPI Klaus Ullherr, Syntegon Technology Folker Steden, SCHOTT Michael Ganio, ASHP |
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| Agility and Responsiveness in the Fight to COVID-19: A case study | Daniel Martinez, Stevanato Group |
| A Systematic Approach to the Evaluation of Vial Container Closure System Suitability at Frozen Conditions | Peter Sargent, Eli Lilly & Company |
| Developing a Readily Available Primary Packaging System for Use in an Ultra-Cold Chain for COVID19 Vaccine Global Distribution – Using a Scientific Approach | Michael Edey, Pfizer Derek Duncan, LIGHTHOUSE |
| LIVE Q&A, Discussion | |
| LIVE Conference Summaries by the Chairs | Roman Mathaes, LONZA Galen Shi, Eli Lilly & Company |
| Thank You Remarks and Farewell | Falk Klar, PDA Europe |
Agenda is subject to change without notice
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