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BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20260414T170000
DTEND;TZID=Europe/Amsterdam:20260414T190000
DTSTAMP:20260502T014041
CREATED:20260402T113153Z
LAST-MODIFIED:20260422T120221Z
UID:8876-1776186000-1776193200@www.dare-nl.nl
SUMMARY:Join4ATMP - Listening to Experiences: The Impact of Patient Involvement in ATMP Clinical Trial Design
DESCRIPTION:The Join4ATMP project has announced the launch of its 2026 webinar series\, aimed at exploring how patient involvement can transform the design of Advanced Therapy Medicinal Product (ATMP) clinical trials. The first session is titled “Listening to Experiences: The Impact of Patient Involvement in ATMP Clinical Trial Design”. Find more information on the series and to registere here.
URL:https://www.dare-nl.nl/event/join4atmp-webinar-listening-to-experiences-the-impact-of-patient-involvement-in-atmp-clinical-trial-design/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20260414T093000
DTEND;TZID=Europe/Amsterdam:20260414T140000
DTSTAMP:20260502T014041
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:20260302T092500
DTEND;TZID=Europe/Amsterdam:20260302T123000
DTSTAMP:20260502T014041
CREATED:20260421T135332Z
LAST-MODIFIED:20260422T120221Z
UID:9144-1772443500-1772454600@www.dare-nl.nl
SUMMARY:EMA - Platform approaches in the non-clinical and clinical domains
DESCRIPTION:The European Medicines Agency organises a webinar bringing together regulators and medicine developers to discuss the use of platform approaches beyond the quality and manufacturing domains. \nThe proposal for the EU pharmaceutical legislation introduces the concepts of platform technologies and platform marketing authorisation. \nThe main objectives of the webinar are: \n\nClarifying the current EU legal framework for the development and marketing of individualised therapies (n=1) and for the use of prior knowledge in Marketing Authorisation dossiers;\nPresenting case studies on the use of platform approaches in the non-clinical and clinical domains and exploring their possible applications and values;\nDiscussing the challenges and identify opportunities related to the use of platform approaches;\nFacilitating the implementation of the EU pharmaceutical legislation provisions on platform technologies and platform marketing authorisation.\n\nYou can find the broadcast here. \n 
URL:https://www.dare-nl.nl/event/ema-platform-approaches-in-the-non-clinical-and-clinical-domains/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20260129T090000
DTEND;TZID=Europe/Amsterdam:20260129T143000
DTSTAMP:20260502T014041
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;VALUE=DATE:20251204
DTEND;VALUE=DATE:20251205
DTSTAMP:20260502T014041
CREATED:20260422T063848Z
LAST-MODIFIED:20260422T120221Z
UID:9196-1764806400-1764892799@www.dare-nl.nl
SUMMARY:Johnson&Johnson - Reducing vein-to-vein time for cell therapy
DESCRIPTION:This event invites innovators to present solutions which can compress the vein-to-vein timeline and unlock the full potential of CAR-T therapy for more patients\, faster. One of the speakers also showcases their innovation in in vivo gene therapy as a next generation solution. You can press here to watch the webinar.
URL:https://www.dare-nl.nl/event/johnsonjohnson-reducing-vein-to-vein-time-for-cell-therapy/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251030
DTEND;VALUE=DATE:20251031
DTSTAMP:20260502T014041
CREATED:20260422T064724Z
LAST-MODIFIED:20260422T120221Z
UID:9203-1761782400-1761868799@www.dare-nl.nl
SUMMARY:EMA - Regulation of ATMPs in Europe: present and future
DESCRIPTION:In this webinar Dr. Ana Hidalgo-Simon will give an overview on the journey of ATMP development and what the future holds. You can view the webinar here.
URL:https://www.dare-nl.nl/event/ema-regulation-of-atmps-in-europe-present-and-future/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20251007
DTEND;VALUE=DATE:20251008
DTSTAMP:20260502T014041
CREATED:20260422T070031Z
LAST-MODIFIED:20260422T120221Z
UID:9210-1759795200-1759881599@www.dare-nl.nl
SUMMARY:Oncode Accelerator - Building Bridges: From Concept to Clinic with Innovative ATMP pipelines
DESCRIPTION:Cell-based advanced therapy medicinal products (ATMPs) such as CAR T\, CAR NK\, TIL and TCR T therapies represent an emerging form of cancer treatment wherein engineered immune cells form the basis of the therapy.​ However\, the complex techniques needed to generate ATMPs\, and the biological demands to make them effective for various cancer types\, present many challenges. \nLed by pioneers in the field of cell and gene therapy\, the Oncode Accelerator Cell and Gene Therapy Workstream combines topnotch scientific experience with a multidisciplinary academic infrastructure to build and optimize robust preclinical pipelines for ATMP development. \nWatch the recording here of this expert-led webinar\, which took place on October 7th\, 2025 and begin to tap into their extensive scientific expertise\, and learn how you can leverage Oncode Accelerator’s innovative infrastructure and plug-and-play production modules for the development of oncological cell and gene therapies.
URL:https://www.dare-nl.nl/event/oncode-accelerator-building-bridges-from-concept-to-clinic-with-innovative-atmp-pipelines/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250612
DTEND;VALUE=DATE:20250613
DTSTAMP:20260502T014041
CREATED:20260422T070340Z
LAST-MODIFIED:20260422T120221Z
UID:9214-1749686400-1749772799@www.dare-nl.nl
SUMMARY:FAST - Innovatie en betaalbaarheid hand in hand (in Dutch)
DESCRIPTION:Hoe kunnen we innovatie inzetten om geneesmiddelen betaalbaar én toegankelijk te houden? In de nieuwe podcastserie van FAST gaan we op zoek naar antwoorden op deze vraag die steeds urgenter wordt. Aan de hand van praktijkvoorbeelden en gesprekken met experts uit het veld onderzoeken we hoe technologische vernieuwing en kostenbeheersing elkaar niet hoeven tegenwerken\, maar juist kunnen versterken. Hoe innovatie en betaalbaarheid hand in hand kunnen gaan. \nIn de eerste aflevering staat de ontwikkeling en betaalbaarheid van weesgeneesmiddelen centraal. Dit zijn medicijnen voor zeldzame aandoeningen waarvoor vaak geen effectieve behandeling bestaat. Ondanks Europese regelgeving die het ontwikkelen van deze medicijnen moet stimuleren\, blijven de prijzen hoog. Dit leidt ertoe dat patiënten in de praktijk regelmatig moeilijk of helemaal geen toegang hebben tot deze levensveranderende behandelingen. Bekijk de aflevering hier.
URL:https://www.dare-nl.nl/event/fast-innovatie-en-betaalbaarheid-hand-in-hand-in-dutch/
LOCATION:Online
CATEGORIES:Podcast
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250512
DTEND;VALUE=DATE:20250513
DTSTAMP:20260502T014041
CREATED:20260422T070601Z
LAST-MODIFIED:20260422T120221Z
UID:9218-1747008000-1747094399@www.dare-nl.nl
SUMMARY:JOIN4ATMP - Streamlining the ATMP Development Pathway in the EU (Join4ATMP CAR-T Used Case)
DESCRIPTION:Watch the webinar here. Use the password: *5w7gi?D \n 
URL:https://www.dare-nl.nl/event/join4atmp-streamlining-the-atmp-development-pathway-in-the-eu-join4atmp-car-t-used-case/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250410
DTEND;VALUE=DATE:20250411
DTSTAMP:20260502T014041
CREATED:20260422T070814Z
LAST-MODIFIED:20260422T120221Z
UID:9223-1744243200-1744329599@www.dare-nl.nl
SUMMARY:JOIN4ATMP - Rare Disease ATMPs
DESCRIPTION:Watch the webinar here. Use passcode: b4UGM=Xi
URL:https://www.dare-nl.nl/event/join4atmp-rare-disease-atmps/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250325
DTEND;VALUE=DATE:20250326
DTSTAMP:20260502T014041
CREATED:20260422T071905Z
LAST-MODIFIED:20260422T120221Z
UID:9232-1742860800-1742947199@www.dare-nl.nl
SUMMARY:FAST - Challenges in ATMP innovation: LibMeldy
DESCRIPTION:FAST’s webinar series on challenges in ATMP innovation \nAdvanced Therapy Medicinal Products (ATMPs) promise to transform patient care and revolutionize health care. However\, developers often face significant challenges in getting these innovative therapies to patients. Common questions include: \n\nHow can you meaningfully engage patients in your ATMP research?What does it take to effectively design and conduct clinical trials?How do you navigate the complex web of ATMP laws and regulations?\n\nIn this episode experts will talk about the LibMeldy case. Click here to watch this webinar.
URL:https://www.dare-nl.nl/event/fast-challenges-in-atmp-innovation-libmeldy/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20250324T090000
DTEND;TZID=Europe/Amsterdam:20250324T170000
DTSTAMP:20260502T014041
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
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20250318
DTEND;VALUE=DATE:20250319
DTSTAMP:20260502T014041
CREATED:20260422T071446Z
LAST-MODIFIED:20260422T120435Z
UID:9226-1742256000-1742342399@www.dare-nl.nl
SUMMARY:FAST - Challenges in ATMP innovation: iSTOP-CP: intranasal Stem cells to Treat Perinatal brain injury and combat Cerebral Palsy
DESCRIPTION:FAST’s webinar series on challenges in ATMP innovation \nAdvanced Therapy Medicinal Products (ATMPs) promise to transform patient care and revolutionize health care. However\, developers often face significant challenges in getting these innovative therapies to patients. Common questions include: \n\nHow can you meaningfully engage patients in your ATMP research?What does it take to effectively design and conduct clinical trials?How do you navigate the complex web of ATMP laws and regulations?\n\nIn this episode Manon Benders and Cora Nijboer of the UMCU will talk about the iSTOP-CP case. Click here to watch this webinar.
URL:https://www.dare-nl.nl/event/fast-challenges-in-atmp-innovation-istop-cp-intranasal-stem-cells-to-treat-perinatal-brain-injury-and-combat-cerebral-palsy/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241216
DTEND;VALUE=DATE:20241217
DTSTAMP:20260502T014041
CREATED:20260422T072827Z
LAST-MODIFIED:20260422T120439Z
UID:9238-1734307200-1734393599@www.dare-nl.nl
SUMMARY:Johnson&Johnson - Advancing cell & gene therapy by optimizing lentiviral vector design and production
DESCRIPTION:To meet the demand for innovative treatments based on cell therapy\, it’s essential that Johnson&Johnson delivers solutions that are both faster and more cost-effective. Optimizing lentiviral vector (LVV) design and production is critical for advancing a subset of these therapies like CAR-T. \nThe primary challenge lies in developing scalable production systems that achieve high viral titers while ensuring the purity and stability of viral vectors to preserve safety and efficacy. Moreover\, compliance with stringent regulatory requirements is paramount. \nIn this symposium\, Johnson&Johnson addresses  key questions facing the biotech industry today: What are some of the main challenges in improving cutting-edge manufacturing techniques? How can Johnson&Johnsonboost LVV yield and enhance safety profiles? What insights can we gain from viral vector production applied in other areas like vaccines and gene therapy? Watch the webinar here.
URL:https://www.dare-nl.nl/event/johnsonjohnson-advancing-cell-gene-therapy-by-optimizing-lentiviral-vector-design-and-production/
LOCATION:Online
CATEGORIES:Webinar
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20241120
DTEND;VALUE=DATE:20241121
DTSTAMP:20260502T014041
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:20260502T014041
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
END:VEVENT
END:VCALENDAR