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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 CET

    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 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, Poster Session & Virtual Exhibition
    13:45 - 14:45 CET

     

    Module II: Closed System Transfer Devices & Container Closure at Deep Cold Storage
    14:45 - 16:05 CET

    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 LIVE Session Introduction
    Vial/CSTD Compatibility Strategies for USP Implementation Cathy Zhao and
    Fran De Grazio, West
    Container Closure Systems for Cell & Gene Therapy Roman Mathaes, 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, Poster Session & Virtual Exhibition
    16:05 - 17:00 CET

     

    Module III: Automation in Secondary Packaging & Controlling Defects in Primary Packaging
    17:00 - 18:00 CET

    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 LIVE Session Introduction
    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 CET

  • Wednesday, 28 April 2021

    Module IV: Glass & Impact of Packaging Components on Biopharmaceuticals
    12:00 – 13:15 CET

    11:00
    Conference Portal Opens: Create your User Profile ¨ Get Oriented ¨ 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 LIVE Session Introduction
    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 on Polysorbate Degradation, Particle Formation and Surfactant Containing Protein Formulations in Pre-Filled Syringe Drug Delivery Systems Inn Yuk, Genentech/Roche
    Robert Müller, F. Hoffmann-La 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, Poster Session & Virtual Exhibition
    13:15 – 14:15 CET

     

    Module V: Sustainability & Considerations on Silicone Oil in Demanding Applications
    14:15 – 15:10 CET

    Transition to Parallel Tracks
    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 LIVE Session Introduction
    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, Poster Session & Virtual Exhibition
    15:10 – 15:45 CET

     

    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 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

    With Major Stakeholders of the Industry

    • Where are the gaps to provide to the world population?
    • COVID Medicines Packaging: possible shortage and how to combat
    • What does the industry require for best results?
    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, speakers pending confirmation

Highlighted Speakers

Michael C. Ganio
Michael C. Ganio
ASHP
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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