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  • (Bio) Assays in Pre-Clinical and Clinical Development for Biopharmaceuticals and Cell & Gene Therapies

    Master early-stage bioassay techniques such as cell-based assays, biostatistics, validation and qualification
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  • 18th ENII EFIS EJI Summer School on Advanced Immunology

    This Advanced Immunology Summer School is designed for PhD students and early post docs who already have a basic knowledge of immunology. Participation is open to all, not only ENII member institutes. Lab staff members are also welcome to participate.
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  • ADVANCE 5-day Summer School on Cell and Gene Therapies

    Gain knowledge about Manufacturing, Regulatory, and Health Technology Assessment (HTA) & Reimbursement
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  • Advanced Cell Therapy Technology

    This comprehensive 3-day course delivered by Cytiva in NIBRT provides both classroom and laboratory instruction within cell therapy processes and cell manufacturing under good manufacturing practice (GMP) procedures
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  • Advanced Therapies GMP Onboarding

    Advanced course on GMP requirements, Quality Management Systems (QMS), quality controls
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  • Advanced Therapies Training Program

    Verdiep je in Advanced Therapy Medicinal Products (ATMP's): leer alles over cel- en gentherapie, innovatieve technieken voor weefselherstel en gepersonaliseerde geneeskunde.
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  • Advanced Therapy Manufacturing

    Cell/gene therapy manufacturing, quality assurance, product development pathways, GMP compliance, Investigational Medicinal product dossier writing, biosafety
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  • Advances in Point-of-Care Manufacturing: Promise vs. Reality

    Cell and gene therapy products point of care manufactuing and the regulatory landscape
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  • An Introduction to Cell and Gene Therapies: A Beginner’s Guide

    Understand the basics of cell and gene therapies to support you in your role.
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  • Aseptisch werken: de mindset die het verschil maakt

    Basis microbiologie, de werking van een cleanroom, de verschillen tussen reinigen, desinfecteren, decontamineren en steriliseren, de verschillende soorten aseptische opstellingen (LAF, Biosafety, isolator, RABS), staalname en monitoring, persoonlijke hygiëne, aseptisch gedrag.
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  • ATMP manufacturing

    This scientific webinar of the last ADVANCE Webinar series presents an overview of essential aspects of ATMP manufacturing
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  • ATMP Market Access

    This scientific webinar of the last ADVANCE Webinar series presents an overview of essential aspects of ATMP manufacturing - market access.
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  • Basic Principles of ATMPs

    Get up to speed on the essential elements of ATMP production, including the regulatory framework, quality control and documentation processes, manufacturing techniques, cell characterization and quality control methods. This dynamic course is designed with an emphasis on interactivity and practical application, with approximately 50% of its modules incorporating hands-on activities in our state-of-the-art "ATMP manufacturing suite and QC laboratory", built in partnership with Thermo Fisher Scientific.
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  • Basis GMP

    Fundamentele wetmatigheden van de farmaceutische industrie
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  • Basis in validatie

    Uitleg over waarom regulatorische autoriteiten validatie verwachten
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  • Behandelen en schrijven van technische deviaties

    Overzicht van hoe deviaties opgevolgd, onderzocht & gedocumenteerd kunnen worden
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  • Behandelopties voor DLBCL

    Which patients are eligible for CAR T therapies focus on DLBCL
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  • Biotechnology course

    Quality control of monoclonal antibodies, registration process of biosimilars, immunogenicity
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  • CAR T Masterclass 2023

    A refresher course for now and future CAR therapies focused on hematological diseases
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  • CAR T-celbehandeling: ontwikkelingen en overwegingen

    Overview of CAR-T therapies, eligiblity of CAR trials, what do you need to take into account for CAR-T clinical trials
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  • CAR-T e-courses

    Different modules, ranging from patient selection, evaluation, treatments and follow-up, to collection of the starting material by apheresis, reception, delivery and administration
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  • CAR-T: Historical Perspectives, Manufacturing and Clinical Applications

    CAR-T: Basics and application
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  • Cell & gene therapy (ATMP) development

    Key challenges of the ATMPs development cycle – Scientific, Manufacturing, Reimbursement and Regulatory
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  • Cell and Gene Therapy Bioprocessing

    Challenges of translating scientific discoveries into medicinal products such as scaling up lenti-viruses
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  • Cell and gene therapy insights webinars

    Library of cell and gene therapy webinars
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  • Cell and gene therapy webinars

    Library of cell and gene therapy webinars
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  • Cell Bank Establishment & Testing for Biologics, Bioassays and Cell & Gene Therapies

    Gain the confidence to manage cell banking for biopharmaceuticals and ATMPs. You will explore the key regulatory requirements for establishing and testing various cell banks to ensure compliance and quality.
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  • Cell product handeling & regulatory 101

    The Cell Product Handling & Regulatory 101 is a three-hour, on-demand course developed for professionals new to the cell and gene therapy field.
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  • Cell therapies for autoimmune disease: MSC from biology to clinical application

    The Cell Therapies for Autoimmune Diseases: MSCs from Biology to Clinical Application course was developed by global subject matter experts.
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  • Cell therapy leardership program

    The ISCT Cell Therapy Leadership Training Program, established by the ISCT Board of Directors, is a premier initiative designed to develop the next generation of leaders in Cell and Gene Therapy (CGT). To advance this mission, ISCT is offering full-tuition scholarships to 15 scholars for the prestigious 2025 program, led by world-renowned CGT experts.
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  • Cell Therapy Manufacturing: Strategy & Optimation

    This 1-day, in-person training course aims to provide you with advanced knowledge to optimize and standardize cell manufacturing processes.
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  • Cleanroom behavior course

    Upon completion of the training, the participant is fully aware of the impact of the behaviour of staff working in cleanrooms, and how this behaviour may affect the quality of the product.
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  • Clinical case studies on CART

    CAR T case studies
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  • Clinical cell therapy leadership micro course

    Developed by world-renowned leaders in Cell and Gene Therapy (CGT) directing the biennial ISCT Cell Therapy Leadership Training Program, the Cell Therapy Leadership training micro-course is an 10-hour on-demand course designed for Principal Investigators, Clinical Development Scientists, and Industry professionals involved in translational research, product development, and clinical trial sponsorship.
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  • Clinical resesearch regulation in the Netherlands

    Introduction to legislation and procedures on clinical research in the Netherlands. The course contains several themes covering various topics. The first 3 themes ‘The Dutch Review System’ and 'The Mandatory Review of Medical Research' and 'Organizing and submitting a research file' are now open.
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  • Computer System Validation (CSV) – van basics tot advanced

    Definitie en belang van validatie, Data integrity, SCV, CSA
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  • De reis van het medicijn

    Een handreiking voor belangenbehartigers van kanker geneesmiddelen
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  • Determining the Strategy for Bringing Your Therapy to the Patient

    Develop a strategic plan and a business plan for ATMP
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  • Deviations and CAPAs – Perform effective investigations

    This one-day course focuses on the root cause analysis and impact assessment of deviations and the determination of appropriate corrective and preventive actions (CAPAs).
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  • Early Clinical Development (Phase I and II)

    Principles of pharmacology, types of studies in early clinical development
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  • Early-stage professional leadership professional program

    The ESP Leadership Development Program is an ISCT initiative which offers Early Stage Professionals (ESP) the chance to join an ISCT Committee for a two-year term in a formal ESP position. The application deadline is January 6, 2025.
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  • EHA Gene Therapy Techniques Program

    3 courses that describe the theory and application of gene therapy techniques, such as gene addition and genome editing
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  • EHA Immunotherapy Program

    5-course program on immunotherapy in hematological malignancies
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  • Essentials for cell therpay products manufacturing, qualifcation & validation

    This course provides a concise overview for professionals looking to learn the essentials of cell product development, qualification, validation, stability, and regulatory submissions.
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  • Essentials of Cell and Gene Therapy

    GMP and aseptic processing, Manufacturing techniques, Quality control, Risk management
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  • European advanced cell therapy manufacturing & regulatory

    In partnership with the Andalusian Network for the Design & Translation of Advanced Therapies (ANd&tAT), ISCT is proud to offer this online Educational Program on Advanced Therapy Manufacturing free-of-charge for ISCT members.
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  • Finding the Financial Resources for Your Project

    Technology Readiness Levels (TRLs), Public funding opportunities in Europe and Belgium (VLAIO)
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  • Free GMP training

    The basics of GMP for medicinal products for human use and the current legal regulations and guidlines
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  • GDP basis voor supply chain medewerkers in de Life Sciences

    Good Distribution Practices
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  • GDP voor de Responsible Person (RP) in de Life Sciences

    Good Distribution Practices
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  • GMP courses

    GMP, GDP, quality risk management system
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  • GMP e-learning trainings

    GMP introduction, essentials, quality system
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  • GMP training courses

    Aseptic production, microbiological quality control, quality assurance, pharmaceutical microbiology
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  • GMP&GDP training courses

    GMP and GDP
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  • Good Manufacturing Practice (GMP) | GMP Training

    Aseptic production, microbiological quality control, pharmaceutical microbiology, GxP auditing training
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  • Hands-on laboratory bootcamp for cell therapy biomanufacturing

    This five-day expert guided hands-on laboratory training course is designed to train you on laboratory techniques and best practices essential to cell bioprocessing GMP labs.
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  • Hematopoetische stamceltransplantatie en nieuwe cellulaire therapieën

    Sanquin Bloedvoorziening verzorgt de cursus Hematopoetische stamceltransplantatie en nieuwe cellulaire therapieën (voormalige module Stamcellen). De cursus behandelt de technieken waarmee hematopoietische stamcellen en andere producten voor cellulaire therapie worden verkregen en de klinische toepassingen daarvan. Tevens wordt ingegaan op bloedgroepincompatibiliteit en transfusie rondom stamceltransplantatie.
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  • HVAC/cleanrooms: ins and outs

    HVAC system, measure flow profile and factors affecting the flow profile
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  • Immuno-oncology

    This interdisciplinary lab course gives you a realistic insight into the life of a biomedical researcher. Early bird discount: if you apply for this course and pay the course fee before 1st of April 2025, the course is discounted for €1995.00.
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  • Intro tot kwaliteitscontrole (QC) in de Life Sciences

    Basisprincipes van Quality Control
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  • Intro tot kwaliteitszorg (QA) in de Life Sciences

    Kwaliteitsmanagement in de life sciences
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  • Intro tot Root Cause Analysis (RCA)

    Root cause analysis
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  • Introduction to CAR-T cells therapies for Data Managers

    Introducttion to CAR T, reporting on CAR T outcome and frequent complications
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  • Introduction to cell therapy

    Instruction within cell therapy processes and manufacturing under good manufacturing practice (GMP) procedures.
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  • Introduction to translational medicine

    The concept of translational science and medicine
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  • Je wonderbaarlijke immuunsysteem – hoe het je lichaam beschermt

    Basis hoe het afweersysteem werkt
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  • Lab techniques in cell biology

    Cell culture, cell counting and analysis, biobanking, sterility tests, transfection, image analysis
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  • Leidinggeven vanuit kwaliteitsperspectief

    Leidinggeven in GMP cultuur
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  • Manufacturing of ATMPs

    Webinar on the manufacturing of ATMPs
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  • Manufacturing Processes – Integration Between Manufacturing Data and Clinical Data Based Upon Automated Cell Culturing Systems

    Automated CGT manufacturing process using Hitachi, Vision Care and Cyto-Facto
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  • Master’s Degree in Transfusion Medicine and Cellular and Tissue Therapies

    Transfusion medicine has grown exponentially in recent decades. The current concept of transfusion medicine includes both transfusion of blood components and hematopoietic transplants, cellular and tissue therapy and immunotherapy, areas that integrate the curriculum of the University Master’s Degree in Transfusion Medicine and Cellular and Tissue Therapies. This University Master’s Degree has been conceived by the best international experts in this field and is linked to the Chair of Transfusion Medicine and Cellular and Tissue Therapy (CMT3), formed by members of Universitat Autònoma de Barcelona, the Salut i Envelliment Foundation and the Blood and Tissue Bank. From 2022-23, the Master’s Degree expanded its international dimension by offering a joint biennial degree with Leiden University Medical Centre (LUMC), specialising in clinical transfusion, a leader in transfused cellular therapies for regenerative medicine in the Netherlands and linked to Sanquin, the Dutch blood and tissue bank. The collaboration between Universitat Autònoma de Barcelona, Leiden University, Sanquin and the Blood and Tissue Bank forms one of the most potentially powerful international alliances for the creation and transmission of knowledge in the field of Cellular and Tissue Transfusion Medicine, and with the present Master’s Degree as a spearhead with the greatest impact.
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  • Meeting GMP Requirements Globally

    Define GMP from a global perspective and context
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  • Placeholder image

    MITx: Making a Cell Therapy: Principles and Practice of Manufacturing

    Cell therapies, such as CAR-T and stem cell therapies, are an exciting new class of therapeutics with the potential to revolutionize medicine. Learn the biology, engineering, and analytical chemistry behind how these amazing new products are manufactured.
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  • Multiple courses about clean room monitoring and aseptic drug production

    Aseptic production, microbiological quality control, pharmaceutical microbiology
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  • Navigating the Regulatory Requirements for ATMPs

    Developmental scientific and regulatory issues commonly encountered in ATMP dossiers.
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  • Overcoming Regulatory and Quality Concerns for Cell and Gene Therapies

    Learn to navigate the regulatory and quality landscape for CGTs/ATMPs.
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  • PDA training courses

    Multiple courses ranging from aseptic processing to biopharmaceuticals, cleaning, compounding, environmental monitoring, quality risk management system, lyophilization, parenteral packaging, etc
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  • Performing Clinical Trials for ATMPs

    Basic pricipals of clinical trials, factors to consider for designing a successful ATMP-based clinical trials
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  • Pharmaceutical Development of ATMPs Training Course

    Comprehensive overview of the regulatory, quality and good manufacturing practice (GMP) requirements to consider when developing advanced therapy medicinal products (ATMPs)
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  • Pharmaceutical Quality and Regulatory Affairs

    Overview of ATMP manufacture, regulations and quality standards, GMP guidelines and market access
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  • Pharmaceutical Training

    Multiple courses ranging from GxP, regulatory, QMS, auditor training, sterile and biotech and many more
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  • Pilot Educational Program Oncology

    Scientific advice and marketing authorisation assessments for human medicines with focus on oncology
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  • Potency Assay Lifecycle From Development to Validation, QC for Biopharmaceuticals and Cell & Gene Therapies

    Master potency assays throughout the development lifecycle to ensure efficacy and quality of your biologics
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  • Projectmanagement in de Life Sciences

    Project management in een life science organisatie
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  • Protecting Your Intellectual Property

    Basic patent principles, IP rights in life sciences, patent information as a strategic tool
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  • Quality and reproducibility – Issues related to clinical development

    Quality and reproducibility issues encountered during clinical development
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  • Quality and reproducibility – Preanalytical validation and quality systems in biobanking

    Preanalytical quality for biomarker validation
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  • Quality and Reproducibility – Quality in high throughput screening

    QC in high throughput screening
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  • Quality and reproducibility – Reproducibility in preclinical and animal experimentation

    Reproduciblity in in vitro and in vivo research
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  • Quality as a critical step in clinical development of ATMPs

    Importance of potency testing, Changes in manufacturing and implications for clinical development
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  • Quality as critical step in clinical development of ATMPs

    Tumor immunology, check point blockades, CAR T and other novel therapies
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  • Regulatory & Clinical Aspects of ATMPs – 2021 recording

    Regulatory and clinical aspects of ATMP development
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  • Regulatory affairs

    Introduction to regulatory affairs, epidemiology and pharmacoepidemiology, pharmacovigilance, product information, marketing authorisations
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  • Regulatory and Clinical Aspects of ATMPs Development – 2020

    Regulatory and clinical aspects of ATMP development
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  • Regulatory plans for ATMP

    Regulatory aspects of ATMPs, difference between EU, US and Canadian regulatory systems
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  • Scientific advice for ATMPs: What & When to Ask

    Scientific Advice for ATMPs and Q&A covering the three areas of advice: quality, non-clinical and clinical development.
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  • Summerschool 3D Printing and Biofabrication

    Basics of 3D printing, biofabrication and an insight into the challenges encountered when translating 3D printing towards biomedical applications
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  • The implementation of cell counting standards

    The Implementation of the ISO Cell Counting Standards course is a partnership between ISCT and the Standard Coordinating Body (SCB). This course was developed with input from the Subject Matter Experts (SMEs), including NIST, FDA, and device manufacturers, who created the ISO 20391-1:2018 (Part 1) and ISO 20391-2:2019 (Part 2) Standards.
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  • The principles & applications of cell therapy biomanufacturing, characterization & regulatory

    ISCT and CMaT have jointly created this nine-week, part-time, virtual training course to train you on the fundamentals and best practices of CGT biomanufacturing, quality assurance, regulations, bioprocessing requirements, product characterization and assessments (registration deadline: March 1, 2025)
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  • The Relevance of Reproducibility for Drug Development

    Introduction and analysis of the current reproducibility issues by Leonard Freedman PhD, Chief Scientific Officer at Frederick National Laboratory for Cancer Research
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  • The use of cell therapy for autoimmune disease: CAR-T from biology to clinical application

    The 1.5-day in-person Cell Therapies for Autoimmune Diseases: CAR-T from Biology to Clinical Application Course is designed for clinicians, clinical scientists, medical students, and researchers dedicated to translating CAR-T cell therapies from research to clinical practice. Led by pioneers in CAR-T cell development and application, including Bruce Levine, Georg Schett, and Franco Locatelli, the course focuses on the application of CAR-T cell therapies for autoimmune diseases, including severe lupus, myositis, systemic sclerosis, juvenile dermatomyositis, multiple sclerosis, and more.
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  • Train-the-trainer in de Life Sciences

    Training geven (on the job)
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  • Training seminar on regulatory knowledge

    You will learn from ex-regulators how regulators think, and we will guide you through the regulatory landscape. After the seminar, you will have a clearer understanding of how to turn your research into efficient product development, always with the end in mind.
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  • Van molecuul naar medicijn

    In deze leerlijn van 4 online modules leer je als patiëntenvertegenwoordiger welk proces er bij de ontwikkeling van medicijnen doorlopen wordt.
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  • Viral Clearance Strategies for Biopharmaceuticals and Cell & Gene Therapies

    Build effective strategies and techniques to remove or inactivate potential viruses your bioprocesses
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Contact

For questions or comments related to DARE-NL or oncological ATMPs, to become a partner or connect for information

contact us at info@dare-nl.nl.

© DARE-NL

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