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2020 Virus Forum

Virus Forum

Jun 22 - Jun 23, 2020
Brussels, Belgium

  • Conference
  • Europe

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Program Highlights

Join us once again for the PDA Europe Virus Forum, this year to be held on 22-23 June 2020 as a virtual conference!

This event will be immediately followed by the 12th PDA Europe conference on Advanced Therapy Medicinal Products!

Overview

Dear Colleagues,

We would like to warmly invite you to join us once again for PDA Virus Forum, this year to be held on 22-23 June 2020 as a virtual conference.

These truly global meetings are organized under the leadership of PDA in close cooperation with European regulatory agencies and the U.S. FDA. They provide an overview and updates on regulatory expectations and scientific investigations related to virus and TSE safety of biotechnology, plasma-derived and cell-derived medicinal products. 

As in previous years, virus contamination of raw materials as well as emerging viral threats will be discussed. Appropriate risk mitigation strategies consisting of two elements: (1) Testing and processing of raw materials and (2) Virus removal / inactivation capacity of the processes used for production of medicinal products will be taken into consideration.

Guideline ICH Q5A on vial safety evaluation of biotechnology products derived from cell lines of human and animal origin has always been a key regulatory document successfully ensuring viral safety of biopharmaceuticals. After 20 years of successful implementation, this Guideline is now under revision taking the technological developments in virus detection and virus reduction into account. You will have the opportunity to learn about the topics being discussed. This will also include the application of viral safety methods towards continuous manufacturing processes. 

By introducing Next Generation Sequencing (NGS), we are experiencing a revolution in virology, leading to ongoing discovery of new viruses and opening new horizons for research as well as for characterization and control of biopharmaceutical production. The PDA Interest Group on Advanced Virus Detection Technologies (AVTIG) will meet and you will hear about the latest efforts in standardizing and applying these techniques for detection of viral contaminants in biotechnological production. 

This PDA Europe Virus Forum reliably provides attendees a unique opportunity for interactive discussion and benchmarking. Exchange of information between industry and regulators will improve the under¬standing and acceptance of new techniques, highlight new and emerging risks and explain new regulatory approaches. 

Panel Discussions, luncheons, dinners and a networking event will hopefully complete this impressive program and make it into a worthwhile and well-rounded learning experience for you! 

 

We warmly invite you to join us in Brussels this Summer!

Agenda

  • Day 1
  • Day 2
  • Monday, 22 June 2020

    9:00
    Welcome: Opening Remarks & Introductions
    Falk Klar, PDA Europe
    Johannes Blümel, Paul Ehrlich Institut, Conference Chair

    Opening Plenary: Regulatory Updates
    Moderator: Thomas R. Kreil,
    Takeda

    ICH Q5A (R2) Updates and an Update on the Corona Virus Epidemic
    Johannes Blümel, Paul-Ehrlich-Institut

    ICH Q5A Revisions – An Industry Perspective on CHO Cell Product Virus Safety
    Qi Chen, Genentech/Roche

    Q&A, Discussion

    10:40
    Coffee Break, Poster Session & Exhibition

    Session 1: Considerations for Continuous Manufacture
    Moderator: Sebastian Teitz,
    Asahi Kasei

    Regulatory Considerations for Viral Clearance Strategies in a Continuous Setting
    US FDA

    Continuous Viral Inactivation: Utilizing Viral Particles to Define the Minimum Residence Time within a Plug Flow Reactor
    Boehringer Ingelheim

    Novel Spiking Methods Developed for Anion Exchange Chromatography Operating in a Continuous Process
    Millipore Sigma

    Q&A, Panel Discussion

    13:15
    Lunch Break, Poster Session & Exhibition

    Session 2: Viral Clearance
    Moderator: Alison Armstrong,
    Merck KGaA

    Insights into Virus Inactivation by Polysorbate 80 (PS80) in the Absence of Solvent
    Sean O‘Donnell, Eli Lilly & Company

    Of Micelles and Matrices: What Makes a Good Detergent for Virus Inactivation?
    Takeda

    Q&A, Panel Discussion

    15:30
    Coffee Break, Poster Session & Exhibition

    Session 3: Viral Clearance, cont’d
    Moderator: Qi Chen,
    Genentech

    PDA Activities and Updates on the Technical Report 41 on Virus Filtration
    PDA Task Force

    Predicting Viral Clearance: DOE, HTS and AAV Case Studies Utilizing a Non-Infectious MVM Surrogate during Downstream Development
    MockV Solutions

    Nanofiltration as a Robust Methodology Contributing to Viral Safety of Plasma-Derived Therapeutics: 20 Years’ Experience of Plasma Protein Manufacturers
    Plasma Protein Therapeutics Association

    Q&A, Panel Discussion

    17:45
    End of Day 1 & Networking Reception

  • Tuesday, 23 June 2020

    Morning Session: Interest Group Meeting Advanced Virus Detection Technologies
    - Open to all conference attendees -
    Moderator: Arifa S. Khan,
    US FDA

    • Updates and Activities of the Interest Group Advanced Virus Detection Technologies
    • Discussions around different Next Generation Sequencing Methods and Protocols

    Session 4: Virus Detection
    Moderator: Arifa S. Khan,
    US FDA

    Updates from the US FDA
    Arifa S. Khan, US FDA

    Evaluation of RNA Next Generation Sequencing (Transcriptomics Analysis) to Replace In Vivo Tests for Assessing the Viral Safety of Cells
    Pathoquest
    Charles Rivers

    Biogen’s efforts Toward Development of a Next-Generation Sequencing Method for Adventitious Virus Detection
    Biogen

    Q&A, Panel Discussion

    10:45
    Coffee Break, Poster Session & Exhibition

    Session 5: Hepatitis E
    Moderator: Johannes Blümel,
    Paul-Ehrlich-Institut

    Robust Hepatitis E Virus Infection in Human Hepatocytes
    Ruhr University Bochum

    HEV Reduction in Plasma-Derived Medicinal Products Manufacturing Processes
    LFB

    The Cell Culture-derived HEV and the Virus Clearance Study of Plasma Derived Products
    Japan Blood Organization

    Q&A, Panel Discussion

    12:45
    Lunch Break, Poster Session & Exhibition

    Session 6: Emerging Viruses and Contamination Control
    Moderator:
    Andy Bailey,
    ViruSure
    Johannes Blümel, Paul-Ehrlich-Institut

    News from the Biotech Vireome
    Thomas R. Kreil, Takeda

    Risk-Based Viral Segregation Strategies for Modern Manufacturing Facilities
    Genentech

    14:35
    Coffee Break, Poster Session & Exhibition

    Validating Virus Clearance for Medical Devices: Challenges and Regulatory Expectations when Validating Inactivation Steps on Solid Matrices
    Andy Bailey,
    ViruSure

    Industry Experience with Viral Contamination in the Manufacture of Biologic Products and its Implications for Emerging Products
    Consortium on Adventitious Agent Contamination in Biomanufacturing

    Q&A, Panel Discussion

    Closing Summary by the Conference Chair
    Johannes Blümel, Paul-Ehrlich-Institut

    16:30
    Closing Remarks and End of Conference
    Falk Klar, PDA Europe

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

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Travel

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Brussels, Belgium

How to Get Here

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By Car

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Other Options

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Directions

Registration Fees

Early Registration
Registration Type Price by 19 April
Member €1.595
Non-member €1.895
Govern./Health Authority/Academic €700
Young Professional (Member) €700

All fees given in Euro and excluding VAT (21%)







Regular Registration
Registration Type Price after 19 April
Member €1.795
Non-member €2.095
Govern./Health Authority/Academic €900
Young Professional (Member) €900

All fees given in Euro and excluding VAT (21%)







* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

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