PDA ICH Q5A R2 Essentials: Training and Practical Applications Workshop 2025
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Explore the Latest Updates in Viral Safety with ICH Q5A R2
Enhancing Regulatory Guidance for Biologic Manufacturing
The revision of ICH Q5A (R2) marks a significant milestone in the viral safety evaluation of cell lines used in biological manufacturing. Since its original publication in the 1990s, technological advancements and industry practices have driven the need for updated guidelines to ensure stronger viral safety measures.
While maintaining the core principles of viral safety, the revised guideline expands its scope to cover new therapies and innovative modalities. One of the most significant advancements in ICH Q5A R2 is Next-Generation Sequencing (NGS), which is expected to replace traditional in vivo assays and revolutionize viral detection methods.
Key Updates in ICH Q5A R2
- Expanded Scope: Inclusion of novel therapeutic platforms and advanced manufacturing technologies
- Next-Generation Sequencing (NGS): Implementation of cutting-edge techniques for more precise viral detection
- Updated Viral Clearance Strategies: New considerations for applying viral clearance methods across different platforms
Implementing the Revised Guidelines
With the latest training materials developed by the ICH Q5A Expert Working Group, industry professionals now have access to essential resources for implementing these updated guidelines. Through case studies and collaborative discussions, we can explore best practices for integrating these changes into current regulatory frameworks.
Join the Conversation
- Discuss real-world case studies and implementation strategies
- Gain insights from regulatory experts and industry leaders
- Utilize new training materials to enhance compliance and safety measures
Let’s come together to deepen our understanding of ICH Q5A R2 and drive excellence in viral safety evaluation.
Stay informed, stay ahead—be part of the future of viral safety in biologic manufacturing.
Sincerely,
The Workshop Leader
Alison Armstrong, Merck KGaA
SCIENTIFIC PROGRAM PLANNING COMMITTEE
- Alison Armstrong, Merck KGaA
- Andy Bailey, ViruSure
- Johannes Bluemel Paul-Ehrlich-Institut
- Simone Olgiati Merck KGaA
- David van Houte, Regeneron
- Falk Klar, PDA Europe
- Stefanie Nebelin, PDA Europe
Program Highlights
Join this one-day interactive workshop before the PDA Virus Conference 2025, and join the discussion with industry experts on challenges and solutions all around ICH Q5A R2!
The agenda preview is out now.
Agenda
Discover What's Happening Each Day
CEST Daylight Time (UTC +2:00)
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Navigating ICH Q5A R2: From Theory to Practice
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Introduction of New Modalities and Impact of Virus Safety
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Moderator:
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ICH Q5A R2 Annex 6: Genetically Engineered Viral Vectors and Viral Vector-Derived Products
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Minimizing Viral Risk: New Technologies, Testing Approaches
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New Cell Lines: Most Challenging Questions
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Open Discussion
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Coffee Break
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Continuous Biomanufacturing
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Moderator:
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Lunch Break
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Viral Clearance
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Moderator:
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Claiming Virus Reduction from Prior Knowledge
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TEM in Viral Safety: Bridging a Century of Virus Imaging with Modern Testing Standards
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Discussion Round
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Coffee Break
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Panel Discussion
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Moderator:
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Summary of the Workshop and Take-Home Messages
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End of Workshop and Farewell
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Venue Details and Accommodations
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.
PDA recommends the reservation at the following hotel
Scandic Gothenburg Central
Vikingsgatan 7
411 04 Gothenburg,
Sweden
PDA Europe has reserved a limited number of rooms until 09 May 2025.
Book your room at the PDA Group Rate with using the above-mentioned reservation button and following code: BOPT220625. The rate is valid from Sunday, 22 June to Saturday, 28 June 2025.
Travel in Style with Lufthansa Group Airlines
We are excited to partner with Lufthansa Group Airlines to offer discounted flights for attendees of the PDA ICH Q5A R2 Essentials: Training and Practical Applications Workshop 2025!
Special Offer Details:
Use the exclusive discount code: MCDE6231
Take advantage of reduced fares to make your travel to the conference both convenient and cost-effective. Don’t miss this opportunity to join us while enjoying a seamless travel experience!
Registration
Pricing Options
To claim your discount, please reach out to registration-europe@pda.org.
Standard Registration
Member Price
€1,150Non-Member
€1,150
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. registration-europe@pda.org
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact registration-europe@pda.org before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
Sponsorship and Exhibit Opportunities are available!
For more information about exhibit and sponsorship opportunities, please contact:
Christopher Härtig
Senior Manager Exhibition & Sponsorship
Email
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