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2021 ParPack_1988x680

2021 PDA Parenteral Packaging Conference

Parenteral Packaging in a New Era: Convergence of Patient, Process and Product Needs

Apr 27 - Apr 28, 2021
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Europe
  • Online
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! 

Overview

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

Agenda

  • Day 1
  • Day 2
  • 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
    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
    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.
    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 
    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.
    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

  • 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
    Track A
    Glass
    Track B
    Impact of Packaging Components on Biopharmaceuticals
    Moderators:
    Folker Steden, SCHOTT
    Jörg Zürcher, Bayer
    Moderators:
    Philippe Lauwers, Terumo
    Roman Mathaes, LONZA 
    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.
    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
    Moderators:
    Folker Steden, SCHOTT
    Derek Duncan, LIGHTHOUSE
    Moderators:
    Robert Ovadia, Gilead
    Galen Shi, Eli Lilly & Company
    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.
    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              
    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

Highlighted Speakers

Bettine Boltres
Bettine Boltres
West Pharmaceutical Services
Derek I. Duncan
Derek I. Duncan
LIGHTHOUSE Instruments
Michael Edey
Michael Edey
Pfizer Global Supply
Michael C. Ganio
Michael C. Ganio
ASHP
Donald Klein
Donald Klein
DLK Consulting Services
Daniel Martinez
Daniel Martinez
Stevanato Group
Roman Mathaes
Roman Mathaes
LONZA
Galen Shi
Galen Shi
Eli Lilly and Company

Registration Fees

Register Now
Registration Type Price after 28 Feb 2021
Virtual Member €1.695
Virtual Non-Member €1.995
Virtual Co-Viewer €99
Virtual Govern./Health Authority/Academic/Young 
Professional (Member)
€650

All fees given in Euro, excluding VAT









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