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PDA Europe Virtual Conference - Pharmaceutical Freeze Drying Technology

Lyophilization in an Evolving Regulatory & Manufacturing Environment

Sep 24 - Sep 25, 2020
Central Europe Standard Time | Online
  • Virtual
  • Conference
  • Online
  • Europe
Program Highlights
 

Overview

Dear Colleagues,

We are proud to announce that this year’s PDA Europe Pharmaceutical Freeze Drying Technology will be presented as a Virtual Conference on 24-25 September.

 

With the 2020 theme of Lyophilization in an Evolving Regulatory & Manufacturing Environment the Program Planning Committee is currently putting together an exciting program presented in interactive online module sessions!



SCIENTIFIC PROGRAM PLANNING COMMITTEE

Raf De Dier, Janssen J&J, Chair
Yves Mayeresse, GSK Vaccines, Chair
Thomas Beutler, GEA
Anthony Cannon, MSD
Julian Gitter, Bayer
Sabine Hauck, Leukocare
Jörg Lümkemann, F. Hoffmann-La Roche
Sascha Pfeiffer, Lyo Engineering
Kevin Smyth, PDA Ireland Chapter
Falk Klar,
PDA Europe
Sylvia Becker, PDA Europe

Agenda

  • Day 1
  • Day 2
  • Thursday, 24 September 2020

    Module I: Opening and Novel Manufacturing Technologies and Regulatory Updates
    13:00 - 14:45 CEST

    Welcome & Introductions Falk Klar, PDA Europe
    Welcome from the Chairs Raf De Dier, Janssen J&J, Chair
    Yves Mayeresse, GSK Vaccines , Chair
    Novel Manufacturing Technologies and Regulatory Updates

    Moderators:
    Yves Mayeresse, GSK Vaccines
    Raf De Dier, Janssen J&J

    Challenging the Lyophilization Process to Provide Convenient, Cost Effective and Compliant Parenteral Drugs Daniel Kullmann, Roche
    Regulatory Strategies and Approaches for Freeze-Drying – Industry Experience Kristina Sennvik, GSK
    Updates on Annex 1 Dieter Bachmann, Janssen Pharmaceuticals - a J&J Company

    Live Q & A, Discussion

    Break, Exhibition & Poster Session
    14:45 - 15:45 CEST

     

    Module II: Process Development and Formulation
    15:45 - 18:10 CEST

    Process Development and Formulation

    Moderators:
    Anthony Cannon, MSD
    Julian Gitter, Bayer

    Heat Flux Sensor to Create Design Space in Primary Drying Monica Rosa, Coriolis
    Freeze Drying of Co-Solvent System at Bulk Stage Yves Mayeresse, GSK Vaccines

    Break, Exhibition & Poster Session

    Influence of Freezing Conditions in the Structure and Material Properties of a Freeze-Dried Protein Formulation Maria Badal Tejedor, Cepheid
    Formulations to Stabilize Spray-Dried and E-Beam Sterilized H1N1 Influenza A Vaccines Sabine Hauck, Leukocare

    Live Q & A, Discussion

     

    Virtual Networking Event
    18:10-19:00 CEST

    Revision of Annex 1 - What's New for Lyo? Green Technologies - What's New in Manufacturing?

    Details subject to change without notice

  • Friday, 25 September 2020

    Module III: Equipment and Primary Materials
    11:00 - 13:15 CEST

    Equipment and Primary Materials

    Moderators:
    Thomas Beutler, GEA
    Joerg Luemkemann, Roche

    Air Refrigeration for Lyophilization Thomas Frank, Refolution
    Advanced Lyo Interfaces to Auto Loading Systems- Industries Requirements Maik Guttzeit, Bayer

    Break, Exhibition & Poster Session

    Extractables & Leachables Qualification of Container/Closure Systems for Freeze Dried Drug Products: Nice to Have or a Necessity? Piet Christiaens, Nelson Labs
    Impact of Elastomeric Closures on A Freeze-Dried Cake Simon Kervyn, Datwyler

    Live Q & A, Discussion

    Break, Exhibition & Poster Session
    13:15 - 14:15 CEST

     

    Module IV: Analytical Tools & Closing
    14:15 - 15:45 CEST

    Analytical Tools

    Moderators:
    Sabine Hauck, Leukocare
    Raf De Dier, Janssen J&J

    Using Isothermal Calorimetry to Study the Influence of Excipients and Processes on the Glassy Dynamics of Lyophilized Products Sebastian Groël, Ludwig-Maximilians-University Munich
    Z-FDM: Micro-Sample Impedance Spectroscopy for Freeze-Dried Formulation Development Geoff Smith, De Montfort University

    Live Q & A, Discussion

    Conference Summary and Farewell Raf De Dier, Janssen J&J
    Yves Mayeresse, GSK Vaccines
    Closing: Chair Awards, Outlook and Farewell Falk Klar, PDA Europe

    Details subject to change without notice

Highlighted Speakers

Maria Badal Tejedor
Maria Badal Tejedor
Cepheid
Piet Christiaens
Piet Christiaens
Nelson Labs NV
Thomas Frank
Thomas Frank
Refolution Industriekälte GmbH
Sebastian Gröel
Sebastian Gröel
Ludwig-Maximilians-University Munich
Daniel Kullmann
Daniel Kullmann
Hoffmann-La Roche
Monica Rosa
Monica Rosa
Coriolis Pharma Research GmbH
Kristina Sennvik
Kristina Sennvik
GSK
Geoff Smith
Geoff Smith
De Montfort University

Registration Fees

Register Now
Registration Type Registration Fee
Member, Non-Member, Young Professional, Poster-Presenter € 1.395
Govern./Health Authority/Academic € 645

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