2023 PDA Viral Safety for ATMPs Workshop

Name: 2023 PDA Viral Safety for ATMPs Workshop
Start: 2023-06-19
End: 2023-06-19

Jun 19, 2023

Madrid, Spain

Understanding the Challenges and Risk Mitigation Strategies

Workshop

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Europe

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Overview
Agenda
Additional Information
Travel
Registration Fees
Exhibit & Sponsorship
Related Events
Contact

Note PDA is committed to deliver safe and secure in-person events. In conjunction with the venue and vendors supporting our event, PDA strictly adheres to all national, provincial and local government regulations. PDA is closely monitoring the situation and will continue to update this information if required.

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!

Overview

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!

Sincerely,
The Workshop Leader

Sean O'Donnell, Eli Lilly and Company

SCIENTIFIC PROGRAM PLANNING COMMITTEE

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

Agenda

Download full Agenda

Monday, 19 June 2023

10:00

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
Moderator:
Sean Michael O'Donnell, Eli Lilly and Company
Co-Moderator:
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

Moderator:
Andy Bailey, ViruSure

12:45 - 13:45 Lunch Break

13:45 - 17:00 I Topic: Downstream Virus Removal for Viral Vector Products
Moderator:
Alison Armstrong, Merck KGaA
Co-Moderator:
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

Moderator:
Andy Bailey, ViruSure
Co-Moderator:
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
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

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 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.

Directions

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].

All prices in Euro (EUR), excluding VAT

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
[email protected]

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Featured Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

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Exhibitor Standard Contract Clause

Media Partners

Related Events

Contact

Program Inquiries

Stefanie Nebelin

Senior Manager Programs & Events

[email protected]

Exhibition Inquiries

Christopher Haertig

Manager Exhibition & Sponsorship

[email protected]

Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10
[email protected]

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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2023 PDA Viral Safety for ATMPs Workshop

Registration Options

Individual Registration

Group Registration