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PDA Workshop

2023 PDA Viral Safety for ATMPs Workshop

Jun 19, 2023
Madrid, Spain

Understanding the Challenges and Risk Mitigation Strategies

  • Workshop
  • Europe

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Program Highlights

The agenda is out now!

Join this one-day interactive workshop prior to the 2023 PDA Virus Conference, and join the discussion with industry experts on Viral Safety for ATMPs!


Dear Colleague,

We would like to invite you to the 2023 PDA Viral Safety for ATMPs Workshop to take place on 19 June 2023 as a face-to-face event in Madrid, Spain prior to the 2023 PDA Virus Conference.

We look forward to welcoming you!

The Workshop Leader

Sean O'Donnell, Eli Lilly and Company


  • Sean O'Donnell, Eli Lilly and Company
  • Alison Armstrong, Merck KGaA 
  • Chakameh Azimpour, Amgen
  • Andy Bailey, ViruSure
  • Johannes Bluemel, Paul-Ehrlich-Institut
  • Arifa Khan, U.S. FDA
  • Sebastian Teitz, Biopharma Excellence 
  • Falk Klar, PDA Europe
  • Stefanie Nebelin, Senior Manager Programs & Events, PDA Europe


  • Monday, 19 June 2023


    Welcome and Introduction
    Falk Klar, PDA
    Sean Michael O'Donnell, Eli Lilly and Company

    10:05 - 12:45 I Topic: Viral Safety of Raw Materials for Cell Therapy
    Sean Michael O'Donnell, Eli Lilly and Company
    Sebastian Teitz, Biopharma Excellence

    10:05 I Viral Safety of Cell Therapy
    Johannes Blümel, Paul-Ehrlich-Institut

    10:25 I Evolving Towards Safer Ancillary Materials: Viral Cleanup of Human Platelet Lysate
    Hatim Hemeda, PL BioScience

    10:50 I Nanofiltration of Growth Media Supplemented with Human Platelet Lysates for Pathogen-Safe Xeno-Free Expansion of Mesenchymal Stromal Cells
    Thierry Burnouf, Taipei Medical University (TMU), -remote presentation-

    11:15 - 11:45 Coffee Break

    11:45 - 12:45 I Open Group Discussion
    Following topics will be evaluated with inputs from the audience
    • Fetal Bovine Serum (FBS)
    • Human Serum
    • What Type of Material and their Need
    Andy Bailey, ViruSure

    12:45 - 13:45 Lunch Break

    13:45 - 17:00 I Topic: Downstream Virus Removal for Viral Vector Products
    Alison Armstrong, Merck KGaA
    Johannes Blümel, Paul-Ehrlich-Institut

    13:45 I Virus Safety of Adeno-associated Virus (AAV) Vector Products (Virus Clearance and Testing for Helper Viruses)
    Anurag Sharma, U.S. FDA -remote presentation-

    14:10 I A Platform Approach to the Development and Validation Replication of Competent Assays for Viral Vector Products
    Amy Bennett, Charles River

    14:35 - 15:05 Coffee Break

    15:05 - 16:35 I Open Group Discussion
    Following topics will be evaluated with inputs from the audience
    • Comparability between PCR Testing and Infectivity
    • Acceptance of PCR Test Results for Infectivity
    • Next Generation Sequencing
    Andy Bailey, ViruSure
    Arifa Khan, U.S. FDA


    16:35 I Summary of the Workshop and Take-Home Messages
    Sean Michael O'Donnell, Eli Lilly and Company

    16:55 I Farewell
    Falk Klar, PDA

    17:00 End of Workshop

    The 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
    • Raw Materials
    • Consumables
    • Equipment
    Governmental Health Authorities
    • National/Local Authorities
    • European Authorities
    • International Authorities
    Service Providers
    • CDMOs
    • Contract Test Laboratories
    • Logistic Companies
    • Freelancer
    • Consulting Firms
    • Universities
    • Academic Research Institutes

Got a Question? We have answers

Contact Us


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

    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 the 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.


Registration Fees

Regular Price
Registration Type Price
All Participants €975

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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