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DTSTART;TZID=Europe/Amsterdam:20260414T093000
DTEND;TZID=Europe/Amsterdam:20260414T140000
DTSTAMP:20260422T194736
CREATED:20260225T083254Z
LAST-MODIFIED:20260422T120221Z
UID:7596-1776159000-1776175200@www.dare-nl.nl
SUMMARY:DARE-NL - Workshop on Navigating Comparability in ATMPs
DESCRIPTION:About \nJoin us for an interactive workshop on the practical application of Quality by Design (QbD) and the critical challenges of process comparability and tech transfer of ATMPs. \nSince regulations for ATMPs provide a framework rather than a strict checklist\, developers must learn to navigate these guidelines. Expert consultants will kick off by aligning the playing field: explaining the essential QbD concepts (TPP\, CQAs\, process controls) using an established model and discussing how to translate these to the intrinsic variability of ATMPs. \nTo bridge the gap between theory and clinical reality\, hospital pharmacist Bahez Gareb (UMCG) will present a comprehensive set of real-world scenarios. Ranging from cross-border comparability and mid-study vector changes to the current multi-center tech transfer within the Netherlands\, he will illustrate the approach\, obstacles and lessons learned. \nWhether you are a novice looking for a roadmap or an expert facing specific hurdles\, this workshop offers actionable insights into the governance\, statistics\, and practicalities of ATMP development.   \nRegister here to attend the workshop. \nNB: this workshop is for DARE-NL partners only. \n  \nAgenda \n09:30 – 10:00  |  Walk-in \n10:00 – 10:10  |  Introduction & meeting goals                             Inge Jedema (NKI) \n10:10 – 10:50  |  Fundamentals of comparability and Quality by Design                              Ineke Jonker (Eagle Pharma)\, Patrick Burger & Sara Melief (3D-PXC) \n10:50 – 11:10  | Engineering comparability in early-phase CAR-T: risk-based \n                             equivalence in practice                             Thilo Buck & Frank van Engelenburg (Progress) \n11:10 – 11:30  |  Coffee break \n11:30 – 12:15  |  Real-world case studies                               Bahez Gareb (UMCG) \n12:15 – 13:00  |  Discussion based on survey input                               Moderator: Inge Jedema (NKI) \n13:00 – 14:00  |  Lunch \n\n  \n  \n\n 
URL:https://www.dare-nl.nl/event/comparability-workshop/
LOCATION:Princess Máxima Center\, Heidelberglaan 25\, Utrecht\, 3584CS\, Netherlands
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20260129T090000
DTEND;TZID=Europe/Amsterdam:20260129T143000
DTSTAMP:20260422T194737
CREATED:20260115T105718Z
LAST-MODIFIED:20260422T120221Z
UID:6657-1769677200-1769697000@www.dare-nl.nl
SUMMARY:DARE-NL - ATMP Trial Registry Symposium 2026
DESCRIPTION:Finding clinical trials involving ATMPs are still a challenge in the current clinical trial registries. This symposium is a great opportunity to gain insights and discuss bottlenecks with experts in clinical trial registries. Find detailed information on the program and the overview of the day below. \nParticipation is free but you will have to register in order to join. For registration click here. Registration is possible untill the 21st January 2026. \n\n\n\n\n\n\nDetailed information: \nThe role of CCMO’s OMON trial registry \nThe number of clinical trials for ATMPs is increasing and therefore it is important the information can easily be found and accessed. The OMON registry is the clinical trial registry developed by the CCMO which contains all the information on every clinical trial in the Netherlands. Paula Vossebeld and Stan van Belkum from the CCMO will give an overview on how the OMON registry works\, the development\, and their way of working as compared to other registry systems like CTIS. \nJOIN4ATMP database\, website and app \nJOIN4ATMP is a consortium that brings together all members of the European University Hospital Alliance with the existing EU-funded T2EVOLVE and RESTORE networks\, and with active support from industry partners and patient representatives as core partners. Nara Marella & Antonia Muller will present some of the tools they have developed in this project to get an overview of the European centers that develop ATMPs. In addition\, they will discuss the results on the survey involving all ATMP centers in Europe. Find and feel free to take the survey here – feedback will be discussed at the symposium. \nPatient perspectives on clinical trial registries \nBeing able to find information on clinical trials is not only important for clinicians and scientists\, but also for patients and their representatives. Patient organizations talk with policymakers\, hospitals\, universities and research institutions in and outside of the Netherlands with the aim to improve patient access and patient lives. Access to clinical trials and the information around it is therefore critical\, and in this session Joost Groen will provide his perspective from his own experience. Mara Tihaya will present the input provided by the DARE-NL Patient Advisory Board. This will be an interactive session for patient representatives in the audience to provide their own perspectives\, experiences\, requirements and recommendations. \nWorkshop \nAfter the break\, a workshop will be held in a computer lecture room. The main goal of this workshop is to navigate the OMON registry and find specific information on clinical trials guided by demonstrator cases. You will be able to perform guided searches\, ask questions to the experts and provide immediate feedback. You will also be asked to provide feedback on the OMON registry that the CCMO can use to further develop the tool. \n\n\n\n\n\nProgram: \n09:00 – 09:30  | Walk-in \n09:30 – 09:40  | Introduction & meeting goals \n09:40 – 10:40  | Paula Vossebeld & Stan van Belkum:  Challenges and detailed insights into the OMON registry \n10:40 – 11:00  | Break \n11:00 – 11:30  | Nara Marella & Antonia Muller: JOIN4ATMP database\, website and app \n11:30 – 12:00  | Mara Tihaya & Joost Groen: Patient perspective on clinical trial registries \n12:00 – 13:00  |  Lunch \n13:00 – 14:30  | Workshop: exploring the OMON trial registry
URL:https://www.dare-nl.nl/event/dare-nl-atmp-trial-registry-symposium-2026/
LOCATION:UMC Utrecht\, Heidelberglaan 100\, Utrecht\, Utrecht\, 3584CX\, Netherlands
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250324T090000
DTEND;TZID=Europe/Amsterdam:20250324T170000
DTSTAMP:20260422T194737
CREATED:20260421T133908Z
LAST-MODIFIED:20260422T120333Z
UID:9113-1742806800-1742835600@www.dare-nl.nl
SUMMARY:DARE-NL - Operator Workshop 2025
DESCRIPTION:A workshop organized for and by ATMP operators\, technicians and other experts handling\, developing and/or producing ATMPs​. The goal of the workshop was to exchange experiences\, common practices and challenges\, stimulate interaction and foster collaborations​. \nProgram: \n09.00 – 09.30      Welcome with coffee & tea \nSession 1: Disinfection \n09.30 – 10.15    Karin Hanraets (STAXS): Training on bringing materials into the cleanroom \n10.15 – 10.30     Anouk Donners (UMCU): Training on environmental monitoring \n10.30 – 11.30     Break-out session\, topics: \n\nprocedures for difficult materials\nenvironmental monitoring\ncross-contamination and line clearance\ngowning\n\n11.30 – 12.30     Lunch \n. \nSession 2: Cell culture methods \n12.30 – 12.45     Cor Berrevoets (EMC): Current manual culture and harvesting procedure \n12.45 – 13.30     Maaike van Zon & Saskia Scheij (NKI): Transition to upscaling and automated process​ on Xuri Cell Expansion System \n13.30 – 14.00     Sabrina Veld (LUMC) & Annet Daudeij (UMCU): Productions ​on the CliniMACS Prodigy \n14.00 – 14.30     Gaby Rijsdijk (Sanquin) & Niek van der Zee (AUMC): Productions on the Cocoon Platform ​ \n14.30 – 15.00     Break​ \n. \nSession 3: QC analysis \n15.00 – 16.00     Break-out session\, topics: \n\ncell count and viability\ncharacterization assays (e.g. phenotype\, flow cytometry)\nfunctional assays (incl potency)\nmicrobiology & virus assays (contaminants\, virus determinants)\n\n16.00 – 16.15     Concluding remarks \n16.15 – 17.00     Drinks​ \n  \n 
URL:https://www.dare-nl.nl/event/dare-nl-operator-workshop-2025/
LOCATION:UMC Utrecht\, Heidelberglaan 100\, Utrecht\, Utrecht\, 3584CX\, Netherlands
CATEGORIES:Event
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BEGIN:VEVENT
DTSTART;VALUE=DATE:20241120
DTEND;VALUE=DATE:20241121
DTSTAMP:20260422T194737
CREATED:20260422T073509Z
LAST-MODIFIED:20260422T120433Z
UID:9245-1732060800-1732147199@www.dare-nl.nl
SUMMARY:EMA - Translating Innovation into access for ATMPs
DESCRIPTION:This meeting is about translating innovation into acces for ATMPs: third EU-innovation network multi-stakeholder meeting. The recorded meeting can be found here.
URL:https://www.dare-nl.nl/event/ema-translating-innovation-into-access-for-atmps/
LOCATION:Online
CATEGORIES:Event
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20241010T090000
DTEND;TZID=Europe/Amsterdam:20241010T170000
DTSTAMP:20260422T194737
CREATED:20260422T073220Z
LAST-MODIFIED:20260422T120437Z
UID:9241-1728550800-1728579600@www.dare-nl.nl
SUMMARY:EMA - Advanced Therapy Medicinal Products - ‘Contribution\, evolution\, revolution’
DESCRIPTION:This symposium will showcase how the work of CAT has contributed to the regulatory framework for ATMPs in Europe and to the approval of these innovative products. \nIt will also outline the evolution of CAT and its adaptation to the challenges posed by novel classes of ATMPs. \nThe ultimate objective is to ensure that high quality\, safe and efficacious products become new treatment options. \nMany more novel developments are on the horizon. Each has the possibility to revolutionise patient care\, and their own merits and challenges. \nYou can view the page for the program and watch the complete recording here.
URL:https://www.dare-nl.nl/event/ema-advanced-therapy-medicinal-products-contribution-evolution-revolution/
LOCATION:EMA Building Netherland\, Domenico Scarlattilaan 6\, Amsterdam\, 1083 HS
CATEGORIES:Event
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