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2023 VirusConf-1988x680

2023 PDA Virus Conference

Jun 20 - Jun 21, 2023
Madrid, Spain

Virus Safety in the Era of ICH Q5A (R2)

  • Conference
  • Europe

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Program Highlights

The agenda preview is out now!

Overview

Dear Colleagues,

A very warm welcome on behalf of the Scientific Program Planning Committee and PDA. We are pleased to invite you to join us for the 2023 PDA Virus Conference to take place as a face-to-face event on 20-21 June 2023 in Madrid, Spain. This conference will follow a workshop hosted by PDA on "Viral Safety for ATMPs" due to take place on 19 June 2023 at the same venue as the 2023 PDA Virus conference.

This global meeting is organized in close collaboration with an excellent Scientific Program Planning Committee which includes European and U.S. FDA regulators, global industry experts, supplier specialists, and dedicated PDA support.

The overall program is designed to provide an update on regulatory expectations from a truly global perspective with representatives from the EU, the US, and Asia presenting the scientific framework for virus safety of plasma-derived and biotechnology medicinal products, as well as particularly innovative advanced therapy medicinal products. Following on from the recent publication of the draft ICH Q5A R2 document, one of the conference's main themes will be best practices and understanding of the recommendations in this draft document.

Similar to earlier events in this long-standing series, current and newly emerging viral threats, viral safety considerations around the selection of low-risk starting materials, virus detection, and identification methods and strategies, and the design and validation of virus inactivation and removal process will be key topics for discussion. In addition, intensified continuous manufacturing processes and their potential impact on facility design and viral safety will also be considered.

Following the great success of the face-to-face meeting in Brussels in 2022, the 2023 PDA Virus Conference will again provide attendees the opportunity to gather for interactive discussions and continue to invigorate social interactions. This meeting continues to act as a discussion forum that allows for the direct interaction between industry and regulators and will continue to support the wider industry and improve the current understanding and acceptance of new technologies, highlight new and emerging viral risks, and explain novel regulatory approaches.

Panel discussions and ample networking opportunities will complement an impressive scientific program and make it a worthwhile and well-rounded experience for you.

We look forward to meeting you in person in June!

Sincerely,

The Chairs

Alison Armstrong, Merck KGaA
Andy Bailey, ViruSure

SCIENTIFIC PROGRAM PLANNING COMMITTEE:

  • Alison Armstrong, Merck KGaA
  • Andy Bailey, ViruSure
  • Johannes Blümel, Paul-Ehrlich-Institut
  • Qi Chen, Genentech/Roche
  • Tomoko Hongo, Asahi Kasei
  • Arifa Khan, U.S. FDA
  • Thomas R. Kreil, Takeda
  • Sean O’Donnell, Eli Lilly and Company
  • Sebastian Teitz, Biopharma Excellence
  • Josh Eaton, PDA
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe

Agenda

  • Day 1
  • Day 2
  • Tuesday, 20 June 2023

    09:00

    Welcome and Introduction
    Falk Klar, PDA
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    Opening Session: International Regulatory Updates
    Moderator:
    Alison Armstrong, Merck KGaA

    Update on Revision of Guideline ICH Q5A
    Paul-Ehrlich-Institut

    Technical Requirements for Platform Validation of Virus Clearance in Clinical Trial Applications and Strategies for Virus Safety Re-Evaluation of Process Changes
    Center for Drug Evaluation - remote presentation-

    Continuous Viral Inactivation or Lifecycle Management for Viral Safety: A Case Study
    U.S. FDA

    Q&A, Discussion

    11:15 - 11:45 Coffee Break, Poster Session & Exhibition

    Session 1: Viral Clearance
    Moderator:
    Tomoko Hongo, Asahi Kasei & Sebastian Teitz, Biopharma Excellence

    Constant Flow Rate Viral Clearance Study of Planova™ BioEX Virus Removal Filter and Implementation into an End-to-End Continuous Process for mAb Purification
    Asahi Kasei

    Utilizing Retrovirus-like Particles (RVLP) to Evaluate Viral Clearance for Multiple Modes of Separation
    Cygnus Technologies

    Improvements of Integrated Cell Culture-RT-qPCR to Facilitate Rapid Detection of Non-Cytopathic Viruses
    CSL Behring

    Q&A, Discussion

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

    Session 2: Round Table Discussions
    Moderator:
    Johannes Bluemel, Paul-Ehrlich-Institut

    Working Group 1
    Moderator:
    Sebastian Teitz, Biopharma Excellence

    Viral Clearance

    Working Group 2
    Moderator:
    Johannes Bluemel, Paul-Ehrlich-Institut

    Testing for Residual Helper Viruses

    Working Group 3
    Moderator:
    Alison Armstrong, Merck KGaA

    New Product Types /Gene Therapies and Vaccines

    Working Group 4
    Moderator:
    Andy Bailey, ViruSure

    Adventitious Agent Testing (AAT)

    Summary of Round Tables & Take-Home Message

    11:15 - 11:45 Coffee Break, Poster Session & Exhibition

    Session 3: Virus Detection
    Moderator:
    Thomas R. Kreil, Takeda

    A Head-to-Head Comparison of Next-Generation Sequencing (NGS) with Conventional Assays for Adventitious Virus Detection
    U.S. FDA & Center for Bioinformatics and Computational Biology, University of Delaware, Newark

    Applying Next-Generation Sequencing Technologies for Virus Safety Testing in a "Revision 2" World
    Merck KGaA

    Q&A, Discussion

    17:35 End of Conference Day 1 and Networking Event

  • Wednesday, 21 June 2023

    09:00

    Welcome to Day 2
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    Session 4: Next Generation Sequencing - Efforts in the Advanced Virus Detection Interest Group (AVDTIG)
    Moderator:
    Arifa Khan, U.S. FDA

    General Updates from the Interest Group, Subgroups and Collaborative Studies
    Invited Speakers

    Study 1: 5 Model Virus Spiking Study to Evaluate Adventitious Virus Detection in a Viral Seed or Vector Preparation

    Study 2: Cell Transcriptomics Study for Evaluating Adventitious Virus Detection in Cell Substrates
    Invited Speakers

    Q&A, Discussion

    10:20 - 10:50 Coffee Break, Poster Session & Exhibition

    Session 5: Manufacturing-Related Aspects
    Moderator:
    Sean O'Donnell, Eli Lilly and Company

    Nucleic Acid Based Assays for Upstream Mitigation and Bulk Harvest Testing
    Amgen

    Viral Risk Assessment of Exosomes: Familiar Strategy for an Unfamiliar Product
    Codiak Biosciences

    Q&A, Discussion

    12:10 - 13:10 Lunch Break, Poster Session & Exhibition

    Closing Plenary: Current Strategies and Challenges in the Future
    Moderator:
    Andy Bailey, ViruSure

    Interactive Questionnaire Session

    Viral Clearance Where Do We Go?
    Charles River

    14:00 - 14:30 Coffee Break, Poster Session & Exhibition

    14:30 - 14:35 Passport Raffle

    Virus Safety Strategies for Chinese Hamster Ovary (CHO) Cell-DeriveS Products Using ICH Q5A R2 Guidance
    Genentech/Roche

    Closing Panel Discussion

    Chairs Conference Summary
    Alison Armstrong, Merck KGaA
    Andy Bailey, ViruSure

    Closing Remarks & Farewell
    Falk Klar, PDA

    16:00 End of Conference

    Agenda is subject to change without notice, Speakers are invited, pending confirmation

Additional Information

  • Who Should Attend
    Pharma Companies
    • Biopharmaceutical Companies
    • Start-ups/Emerging Companies
    Suppliers/Vendors
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    Consultancy
    • Freelancer
    • Consulting Firms
    Academia
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Madrid Marriott Auditorium Hotel & Conference Center

Avenida de Aragon No 400
Madrid, Spain

Make a Reservation
  • Accommodations

    PDA recommends the reservation at the following hotel

    Madrid Marriott Auditorium Hotel & Conference Center
    Avenida de Aragon No 400
    28022 Madrid
    Spain

    PDA Europe has reserved a limited number of rooms by 17 May 2023.

    Book your room at the PDA Group Rate via the above-mentioned reservation button.

  • Amenities

    Madrid Marriott Auditorium Hotel & Conference Center, located between International Airport and city center, is the perfect place to hold any kind of event and conference with innovation and style.

How to Get Here

By Air

Airport Madrid-Barajas is just 7 minutes away from the conference venue. Shuttle schedule to airport from 4:00 am until 2:15 am, from Hotel main entrance to departures in each terminal. The hotel does not guarantee seats available. Please check shuttle schedule operating hours directly with the hotel at 91 400 4400, through social media channels, or by email to [email protected]

By Car

On-Site Parking opportunities are available.

Other Options

Train station Gran Via is around 20 minutes away from the Madrid Marriott Auditorium Hotel.

Directions

Registration Fees

Early Registration
Registration Type Price by 23 April
Member €1.845
Non-member €2.145
Govern./Health Authority/Academic €870
Early Career Professional (Member) €870

Regular Registration
Registration Type After 23 April
Member €2.045
Non-member €2.345
Govern./Health Authority/Academic €970
Early Career Professional (Member) €970

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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