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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240702T160000
DTEND;TZID=Europe/Brussels:20240702T170000
DTSTAMP:20260409T100727
CREATED:20240619T140142Z
LAST-MODIFIED:20250717T102027Z
UID:1764-1719936000-1719939600@www.vennlifesciences.com
SUMMARY:Exploring Non-Clinical Research and Alternative Methods
DESCRIPTION:Toxys & Venn Life Sciences share their insights on the possibilities for use of alternative methods in drug development. \nOur previous webinar on challenges in Non-Clinical Drug Develpment was met with enthusiastic reception and sparked numerous inquiries on alternative\, highlighting the community's keen interest and demand for more information. \nAbout this webinar \nSince studies with animals not always predict accurately for human responses\, the search for alternative methods has been intensified in the last decades. Better predictive non-animal models will decrease the change of failure during late stage clinical drug development. \nA Combination of Legislation & Practice \nIn our upcoming webinar\, we will present current legislation on animal testing and possibilities to use alternative methods in drug development and showcase a real-world case study. Venn will cover the legislative aspects\, while Toxys will highlight their ReproTracker® and ToxTracker® assay\, an innovative in vitro method. Together\, we will demonstrate how these approaches can provide reliable and relevant data in drug development. \nIn the webinar\, we will discuss: \n- Current viewpoints from regulatory authorities\n- Ethical consideration and potential impact on R&D\n- Existing alternative methods in drug development\n- Strategies for incorporating these methods into R&D\n- Succesful case study using alternative methods \nTo further aid your efforts\, we offer attendees the chance to book a free half-hour consultation with an expert\, dedicated to exploring how you can implement alternative methods.
URL:https://www.vennlifesciences.com/event/exploring-non-clinical-research-and-alternative-methods/
LOCATION:Leiden
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20240611T123000
DTEND;TZID=Europe/London:20240611T170000
DTSTAMP:20260409T100727
CREATED:20240522T090302Z
LAST-MODIFIED:20250717T102511Z
UID:1726-1718109000-1718125200@www.vennlifesciences.com
SUMMARY:Quality from Start to Finish: "Do you know what you don't know?"
DESCRIPTION:Join us for an insightful discussion on ensuring quality every step of the way in your product or service journey. From inception to market\, understanding Critical to Quality (CTQ) factors is paramount. We'll delve into the intricacies of research and development\, navigating GxP and IT regulations\, and upholding data integrity throughout the process to empower informed decisions. \nKey Learning Objectives: \n\nKeep Focus on the Dot on the Horizon: Stay aligned with your ultimate goal.\nIdentify Essential Requirements: What are the essentials to reach your goal?\nLeverage Support Networks: Who can help you meet those requirements?\nUnderstanding Cohesion: Recognize the interconnectivity between your needs.\n\nGuest Speakers: \n \nDorrine Bogers\, BSc\, studied analytical chemistry at the university of applied sciences of Eindhoven (NL). She joined Venn in 2002 implementing a Quality Management System based on Good Laboratory Practice\, lead the Quality Assurance Unit and act as a GLP QA consultant. Before joining Venn\, she held operational and management positions in several laboratories\, both CRO’s as governmental\, given her over 30 years of experience with quality systems. She has been involved in several QA projects as project leader or consultant in GLP\, GCP and GMP projects for big pharma and small CRO’s including but not limited to\, physical-chemical\, toxicity\, environmental\, pathological\, analytical\, and clinical chemistry studies. Her experience includes performing GAP analysis and advising how to sculpture a quality system suitable for the business needs of the company and the regulatory requirements. \n  \n \nErik Gout has over 35 years of experience in the pharmaceutical industry. He has been involved in numerous drug development projects as analytical scientist\, pharmaceutical development scientist\, Quality Insurance engineer and CMC project leader. His experiences also include Technology Transfers\, writing\, reviewing\, and approving regulatory CMC documents\, GMP QA audits and due diligence of various projects. He is currently a senior consultant Chemistry\, Manufacturing & Control. \n  \n \nHans de Raad is an experienced IT consultant whose strength is bridging the gap between business needs and IT capabilities\, especially regarding security\, privacy\, and compliance. He ensures that IT infrastructure not only facilitates business processes but seamlessly integrates with organizational objectives without necessitating re-engineering. With about 20 years of experience in various sectors\, including the life science industry\, he is used to adhering to stringent compliance and validation protocols such as GxP\, GAMP5\, FDA Cfr 21 Part 11 and NEN7510. In addition\, he is specialized in compliance auditing\, GDPR/AVG policy implementation\, ISO27001 auditing\, and security best practices coaching. Hans is an active member of the RQA IT Committee and chairman of the DARQA IT Committee. As such he regularly attends discussion meetings and presents the latest insights during events. He is an expert in the intricate process of selecting and implementing electronic quality management systems and providing comprehensive implementation assistance. His methodology extends to crafting User Requirement Specifications and offering validation support. This includes planning\, testing\, and change management. \n  \n \nMartijn Doesborgh is an experienced QMP specialist with over 25 years of experience in several fields of the pharmaceutical industry. Initially starting as a chemical- and process development technician with process validation responsibilities\, over the years he became a Quality Expert. He developed the linking pin position between manufacturing departments and QA\, implementing key communication systems resulting in high levels of (cGMP) compliance and significantly reduced levels of misunderstanding. In 2011 he joined Yxion as a QA consultant. As the lead of the Quality Assurance section he has in the last 4 years empowered the transformation of Yxion into 3 major fields of expertise: Project Management & Enginering\, Commissioning & Qualification & Validation and Quality Assurance. As a QA consultant he has led several Quality Sections of QA and manufacturing departments\, implemented QA on the shopfloor\, and prepared\, hosted\, participated in and followed up on many regulatory inspections (FDA\, IGJ\, ANVISA\, JFDA etc.) and customer audits at manufacturing organizations. \n  \n \nMarijke Steenvoorde is an experienced GCP Quality Assurance Manager. She joined Venn in 2022 to lead the Quality Assurance department. Before joining Venn\, she held positions in Quality Assurance as an owner and consultant of her own company and at Astellas\, giving her 20 years of experience in clinical drug development in pharma and provider alike. She has been involved in numerous clinical drug development projects as a Global Quality Lead and as an Quality Assurance manager in multiple therapeutic areas\, including\, but not limited to\, urology\, dermatology\, oncology\, and gynecology from early discovery to marketing.  Her experiences also include implementation\, improvement and maintenance of a Quality Management System and an audit database as well as management of an audit program and the organization\, conduct\, reporting and follow up of investigator site\, vendor\, and internal audits as well as the preparation\, hosting and follow up of regulatory inspections and the identification of deviations and CAPA follow up. She's a member of RQA and DARQA and has been chair of DARQA for the last 7 years.
URL:https://www.vennlifesciences.com/event/quality-from-start-to-finish-do-you-know-what-you-dont-know/
LOCATION:Plus Ultra Leiden\, Emmy Noetherweg 2\, Leiden\, Leiden\, 2333 BK\, Netherlands
ATTACH;FMTTYPE=image/jpeg:https://www.vennlifesciences.com/wp-content/uploads/2024/05/Venn-Life-Sciences-Website-Events-Banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20240514T133000
DTEND;TZID=Europe/Amsterdam:20240514T180000
DTSTAMP:20260409T100727
CREATED:20240321T142005Z
LAST-MODIFIED:20250717T102203Z
UID:1645-1715693400-1715709600@www.vennlifesciences.com
SUMMARY:Key to Drug Product Development Success: Target Product Profile and Quality by Design
DESCRIPTION:Join us for an insightful event delving into the Target Product Profile (TPP) that helps you set the path for drug product development and supports business decision making. Gain insight on how to determine your CMC development strategy based on this TPP\, and apply Quality by Design (QbD) and Design of Experiments (DoE). Connect with industry experts\, expand your network\, and elevate your CMC strategies. \n4 key learnings: \n\nUnderstanding the drug product’s CMC development road from Target Product Profile to Quality Target Product profile into Quality by Design\nCase studies demonstrating successful QBD implementation.\nLeveraging DOE for process robustness and cost savings.\nTarget Product Profile not only for regulatory purposes but important tool in business decisions\n\nAgenda: \n13h30: Welcome & Registration \n14h00 – 14h15: Kick-off \n14h15 – 14h45: Target Product Profiles (TPP) \n14h45 – 15h00: Break \n15h00 – 15h30: Quality by Design (QbD) \n15h30 – 16h00: Design of Experiments (DOE) \n16h00 – 18h00: Networking \n  \nGuest Speakers: \n \nAnneke Blom\, Senior Consultant CMC \n\nSenior consultant in Chemistry Manufacturing and Control (CMC)\nHead of the CMC department\nOver 20 years in the pharmaceutical industry; held positions at CDMO’s and ‘big pharma’\nSpecializes in drug product development\, particularly sterile injectables\nUtilizes Quality by Design approach\, including Quality Risk Management\nGood understanding of GMP\, ICH guidelines\, and regulatory requirements\nManaged project involving: Formulation and process development\, Analytical method development and validation\, GMP manufacturing\, including batch record\, deviation\, and change control handling\n\n \nRonald Ullers\, Senior Consultant RA-CMC \n\nPh.D. degree in molecular microbiology with over 16 years of experience in the pharmaceutical industry in the field of regulatory affairs.\nHas thorough understanding of the regulatory demands (with focus on CMC) for new biological entities including vaccines\, and new chemical entities for EU/US registrations in various indications and phases of development and market approval.\nHas key experience in preparing and developing RA-CMC strategies and CMC content of regulatory submission documents and liaising with US and EU regulatory agencies\, including authoring of scientific advice/Pre-IND briefing packages and acting as Sponsor representative during scientific advice procedures.\nProvides consultancy and operational support to clients ranging from start-up companies to large pharmaceutical companies.\n\n \nAzra Gholami\, Consultant CMC \n\nPharmacist with a Ph.D in Molecular biology\nHas over 11 years of experience in the pharmaceutical industry.\nHer experience includes process and product characterization in gene therapy\nSpecialized in Quality-by-design based Analytical method development and validation for small and large molecules.\nSpecialized in Biotechnology\, Molecular biology\, and Cell culture including genetic engineering methods.\nExperienced with process optimization by Design of expert (DOE)\, Technology Transfers\, writing\, reviewing\, and approving regulatory CMC documents.
URL:https://www.vennlifesciences.com/event/key-to-drug-product-development-success-target-product-profile-and-quality-by-design/
LOCATION:Emmy Noetherweg 2\, Leiden\, Zuid-Holland\, NL\, 2333 BK\, Emmy Noetherweg 2\, Leiden\, 2333 BK\, Netherlands
ATTACH;FMTTYPE=image/jpeg:https://www.vennlifesciences.com/wp-content/uploads/2024/03/Venn-Life-Sciences-Website-Events-Banner-1.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Amsterdam:20240305T130000
DTEND;TZID=Europe/Amsterdam:20240305T140000
DTSTAMP:20260409T100727
CREATED:20240109T103812Z
LAST-MODIFIED:20250717T102943Z
UID:1529-1709643600-1709647200@www.vennlifesciences.com
SUMMARY:Webinar - Mastering Non-Clinical Challenges in Drug Development: A Roadmap to Success!
DESCRIPTION:Join our upcoming webinar\, designed to untangle the intricacies of non-clinical challenges in drug development. It's imperative to recognize that beyond the clinical aspect\, there exists a complex domain of non-clinical considerations that greatly influence the trajectory of drug development. \nThese considerations range from understanding the potentially toxic effects of compounds to evaluating how they behave within biological systems and even differentiating their characteristics based on their molecular nature. \n\nCommon Non-Clinical Challenges\nOverview: Toxicology\, Safety pharmacology\, Metabolism\, Pharmacokinetics\nNon-Clinical Drug Development of different modalities:\nSmall molecules\nBiologicals\nCGT\nVaccines\nPerforming a GAP Analysis\n\nTo further aid your efforts\, we offer attendees the chance to book a free half-hour consultation dedicated to creating a personalized roadmap for your non-clinical plans based on a GAP analysis with our non-clinical experts. \n \nSpeaker: Arthur Noach\, Non-Clinical Expert \n  \n 
URL:https://www.vennlifesciences.com/event/webinar-mastering-non-clinical-challenges-in-drug-development-a-roadmap-to-success/
LOCATION:Leiden
CATEGORIES:Webinar
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20231121T123000
DTEND;TZID=Europe/London:20231121T180000
DTSTAMP:20260409T100727
CREATED:20230928T125035Z
LAST-MODIFIED:20250717T101858Z
UID:1464-1700569800-1700589600@www.vennlifesciences.com
SUMMARY:Do it right the first time: the value of a drug development plan
DESCRIPTION:Learn from Venn experts who have helped dozens of innovators like you develop the right plan that helped them get funding and approval. \nSign up now to our Kickstart Workshop on building a Drug Development Plan: Don’t do too much but do it right \nJoin us for an afternoon of knowledge sharing\, networking\, and taking your drug development journey to new heights. \nDate: 21 November 2023\nTime: 12:30 PM – 6:00 PM\nLocation: Plus Ultra Leiden\, Emmy Noetherweg 2\, Leiden\, Zuid-Holland\, NL\, 2333 BK \n  \nTopics covered:\n\nDrug Development Plan and how it benefits you\nPreparing your drug\nNon-clinical: always keep your eye on clinical\nThings to consider for early clinical entry\n\n  \nYou will learn:\n\nWhat is a Drug Development Plan and why should you have one\nKey development aspects to go First-In-Human from drug product\, pre-clinical\, and clinical perspective\nHow to avoid common pitfalls and increase the chance of success\nHow to meet expectations of key stakeholders/investors\n\n  \nSpeakers\n\n  \nErik Buntinx - Founding CEO at ANeurotech\n  \nKatsuhiro Mihara - Head of Clinical Development at Venn Life Sciences\nKatsuhiro Mihara\, RPh\, PhD is a registered pharmacist and with a PhD in pharmaceutical sciences from the University of Tokushima. He joined Venn in 2016 to lead the Clinical Development department and is currently also leading Venn’s business in the Netherlands. \nBefore joining Venn\, he held leadership and senior scientist positions in clinical development and pharmacology at Abbott\, Merck Sharp and Dohme\, Schering Plough and Organon\, giving him over 25 years of experience in preclinical/early clinical drug development in big pharma\, biotech and provider alike. \nHe has been involved in numerous drug development projects as project leader\, clinical trial manger and/or study director in multiple therapeutic areas\, including\, but not limited to\, oncology\, immunology\, dermatology\, urology\, gynaecology and CNS from early discovery to marketing. His experiences also include due diligence of various drug development projects with primary focus on risk assessments including evaluation of regulatory documents at major milestones (e.g. pre-IND\, End of Phase I/II meetings) for investors. \n \nLinkedIn: https://www.linkedin.com/in/katsuhiromihara/ \n  \nArthur Noach - Head of Non-Clinical at Venn Life Sciences\nArthur Noach has over 25 years experience in pharmaceutical industry of which more than 23 years as a senior consultant for the non-clinical development of drug candidates\, either small molecules or biologics and vaccines. His experience is in designing the package of non-clinical studies to be performed for starting clinical studies and beyond up to registration\, based on OECD\, ICH and FDA guidelines\, as well as consulting on the set-up of the studies (protocols) and monitoring at contract labs where studies are actually performed. He has a vast experience in writing (non-clinical parts of) briefing books\, Investigator Brochures and IND-modules (eCTD format). Furthermore\, he is acting as consultant and principal investigator for pharmacokinetic and toxicokinetic studies\, either as stand-alone studies or as part of toxicology studies\, both non-GLP and GLP. He obtained a Msc in Pharmacy and a PhD in pharmacology/pharmacokinetics from Leiden University and a PharmD from Utrecht University. \n \nLinkedin: https://nl.linkedin.com/in/arthur-noach \n  \nAnneke Blom - Head of CMC at Venn Life Sciences\nAnneke Blom has over 20 years of experience in the pharmaceutical industry. She held positions at CMO’s and ‘big pharma’ in the field of drug product development\, and here main expertise is sterile injectables. She has managed projects that included formulation and process development\, analytical method development and validation\, GMP manufacturing including batch record\, deviation and change control handling. She has a Thorough understanding of early stage and late stage drug product development by Quality by Design approach including Quality Risk Management. In addition\, she has good knowledge of GMP\, ICH guidelines and regulatory requirements. She is currently senior consultant Chemistry Manufacturing and Control (CMC) and Head of CMC department. \n \nLinkedIn: https://nl.linkedin.com/in/anneke-blom \n  \nMarijke Steenvoorde - Head of QA at Venn Life Sciences\nMarijke Steenvoorde is an experienced GCP Quality Assurance Manager. She joined Venn in 2022 to lead the Quality Assurance department.\nBefore joining Venn\, she held positions in Quality Assurance as an owner and consultant of her own company and at Astellas\, giving her 20 years of experience in clinical drug development in pharma and provider alike. \nShe has been involved in numerous clinical drug development projects as a Global Quality Lead and as an Quality Assurance manager in multiple therapeutic areas\, including\, but not limited to\, urology\, dermatology\, oncology and gynaecology from early discovery to marketing. \nHer experiences also include implementation\, improvement and maintenance of a Quality Management System and an audit database as well as management of an audit program and the organization\, conduct\, reporting and follow up of investigator site\, vendor and internal audits as well as the preparation\, hosting and follow up of regulatory inspections and the identification of deviations and CAPA follow up.\nShe's a member of RQA and DARQA and has been chair of DARQA for the last 7 years. \n \nLinkedIn: https://nl.linkedin.com/in/marijke-steenvoorde
URL:https://www.vennlifesciences.com/event/do-it-right-the-first-time-the-value-of-a-drug-development-plan/
LOCATION:Emmy Noetherweg 2\, Leiden\, Zuid-Holland\, NL\, 2333 BK\, Emmy Noetherweg 2\, Leiden\, 2333 BK\, Netherlands
CATEGORIES:Live Event
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20231102T130000
DTEND;TZID=Europe/London:20231102T140000
DTSTAMP:20260409T100727
CREATED:20231009T090121Z
LAST-MODIFIED:20250717T102435Z
UID:1470-1698930000-1698933600@www.vennlifesciences.com
SUMMARY:Post-Market Alternate Primary Packaging Selection – Topra Webinar
DESCRIPTION:FREE SPONSORED WEBINAR - This webinar will cover the impact to defined Product Performance Specifications and User Needs\,  including the necessary updates to the drug dossier and technical documentation for inclusion in the submission packages. \nChanges are required to approved drug products as part of the lifecycle. To accommodate an alternate primary package\, e.g.: pre-filled syringe (PFS)\, they will often involve changes to technical requirements that have a regulatory aspect.\nImpact to defined Product Performance Specifications and User Needs will be presented\, including the necessary updates to the drug dossier and technical documentation for inclusion in the submission packages. \nLearning outcomes\nParticipants will learn how to approach primary packaging change to appropriately consider that regulatory compliance and submission requirements are duly considered and planned for. \nAudience\nThis presentation is aimed at regulatory professionals\, engineers and project managers involved in Drug Product lifecycle management who wish to learn more about how to manage primary packaging changes involving devices. \nPresenter \n \nMary Sinnott\, Senior CMC Regulatory Consultant\, Venn Life Sciences\nMary has over 24 years of experience in the pharmaceutical industry and medical device industries. She was involved in drug development projects as analytical scientist\, and in managing Global product CMC regulatory strategy and maintenance for marketed products. Mary's experience includes Scale-up\, Analytical Changes\, Technology Transfer\, Issue Management; writing\, reviewing\, and approving regulatory Quality and CMC submission documents.  Notified Body audit & FDA inspection preparation and participation\, Regulatory Knowledge Management\, Benchmarking study\, Business Process Definition
URL:https://www.vennlifesciences.com/event/post-market-alternate-primary-packaging-selection-topra-webinar/
LOCATION:Leiden
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230919
DTEND;VALUE=DATE:20230920
DTSTAMP:20260409T100727
CREATED:20231019T134256Z
LAST-MODIFIED:20250717T102808Z
UID:1459-1695081600-1695167999@www.vennlifesciences.com
SUMMARY:Unravelling the complexity of the ATMP transition from research to clinical
DESCRIPTION:Join the Cutting-Edge Conversation \nAre you ready to embark on an extraordinary exploration of Advanced Therapy Medicinal Products (ATMPs)? Get ready to immerse yourself in the dynamic world of ATMPs development and manufacturing\, led by none other than Ion Tcacencu\, an esteemed ATMP expert with over 17 years of experience in regenerative medicine and immunology. \nSpeaker: Ion Tcacencu\nExpertise: Advanced Therapy Medicinal Products (ATMPs)\, Regenerative Medicine\, Immunology \nDon't miss our exclusive FREE online webinar\, where we delve into the intricate journey of transforming ATMPs from a research-grade concept to a clinical-grade reality. This event is your chance to gain profound insights\, expand your knowledge\, and be at the forefront of medical innovation. \nKey Webinar Agenda:\n- General aspects of ATMPs development\n- Exploring the Quality Target Product Profile (QTPP) and critical quality attributes (CQAs)\n- Navigating the ATMPs manufacturing lifecycle and workflow (from research-grade to GMP)\n- Unveiling the pivotal role of the Drug Development Plan (DDP)\n- Diving deep into real-world Case Studies of scaling up somatic cell-based medicinal products (SCBMPs) \nWho Should Attend:\nThis webinar is a must-attend for professionals and leaders in the following fields:\n- Biotechnology\n- Pharmaceutical\n- Healthcare and Medical Services\n- Regenerative Medicine\n- Research and Development (R&D)\n- Life Sciences\n- Academic and Educational Institutions\n- Government and Regulatory Agencies\n- Clinical Research Organizations (CROs)\n- Science and Technology \nWhat You'll Learn:\nMaster the intricacies of ATMPs development and manufacturing.\nConquer the challenges of transitioning ATMPs to clinical-grade production\, guided by regulatory requisites and stringent quality control.\nTackle the risks associated with scaling up ATMPs\, drawing wisdom from successful strategies and lessons learned from impactful case studies. \nWhy Attend?\nDiscover the latest advancements\, gain unparalleled insights\, and connect with like-minded professionals at the forefront of ATMP innovation. With limited spaces available\, secure your spot now to be a part of this transformative journey! \nRegistration: FREE of charge \nJoin the ranks of biotechnology pioneers\, healthcare visionaries\, and research enthusiasts who are shaping the future of medicine through ATMP excellence. Don't let this opportunity pass you by - register today!
URL:https://www.vennlifesciences.com/event/unravelling-the-complexity-of-the-atmp-transition-from-research-to-clinical/
LOCATION:Leiden
CATEGORIES:Webinar
ATTACH;FMTTYPE=image/jpeg:https://www.vennlifesciences.com/wp-content/uploads/2023/10/Venn-Life-Sciences-Website-Events-Banner.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;VALUE=DATE:20230919
DTEND;VALUE=DATE:20230920
DTSTAMP:20260409T100727
CREATED:20230801T092744Z
LAST-MODIFIED:20230801T092744Z
UID:1414-1695081600-1695167999@www.vennlifesciences.com
SUMMARY:Unraveling the complexity of the ATMP transition from a research-grade to a clinical-grade product
DESCRIPTION:Speaker: Ion Tcacencu –  is an ATMP expert with over 17 years of experience as scientist within regenerative medicine and immunology\, being responsible for projects developing new ATMPs. \nReady to explore the cutting-edge world of Advanced Therapy Medicinal Products (ATMPs)? \nDon't miss our exclusive webinar where we delve into the intricacies of ATMPs development and manufacturing! Sign up now for an insightful agenda featuring key topics: \nAgenda: \n\nGeneral aspects of the ATMPs development.\nOverview of the Quality Target Product Profile (QTPP) and critical quality attributes (CQAs). ​\nATMPs manufacturing lifecycle and workflow (research-grade vs GMP).\nRevealing the importance of the Drug Development Plan (DDP).\nCase studies of scaling up somatic cell based medicinal products (SCBMPs).\n\nKey Learning outcomes/objectives: \n\nComprehend the complexity of ATMPs development and manufacturing\, gaining a deep understanding of the field's intricacies.​\nAddress the unique challenges involved in transitioning ATMPs towards clinical manufacturing\, considering regulatory requirements and quality control.​\nMitigate the risks associated with scaling up ATMPs\, by exploring successful strategies and lessons learned from case studies
URL:https://www.vennlifesciences.com/event/unraveling-the-complexity-of-the-atmp-transition-from-a-research-grade-to-a-clinical-grade-product/
LOCATION:Online
ATTACH;FMTTYPE=image/jpeg:https://www.vennlifesciences.com/wp-content/uploads/2023/08/venn-ATMP-webinar.jpg
END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/London:20230627T120000
DTEND;TZID=Europe/London:20230627T170000
DTSTAMP:20260409T100727
CREATED:20230516T122914Z
LAST-MODIFIED:20250717T102546Z
UID:1233-1687867200-1687885200@www.vennlifesciences.com
SUMMARY:Roadmap To Early Clinical Entry: The Devil Is In The Detail.
DESCRIPTION:Join us on June 27\, 2023\, at Kadans Plus Ultra Leiden for an exclusive\, hands-on workshop: Roadmap To Early Clinical Entry: The Devil Is In The Detail. \nBrought to you by Venn Life Sciences\, part of hVIVO plc\, Centre for Human Drug Research and Batavia Biosciences this workshop offers a comprehensive understanding of the drug development process and insights on creating a robust product development plan. The workshop includes real-world case studies and interactive sessions\, featuring industry experts from Venn Life Sciences\, CHDR\, and Batavia Biosciences. \nKatsuhiro Mihara is a registered pharmacist and PhD in pharmaceutical sciences with over 25 years of experience in preclinical/early clinical drug development in the pharmaceutical industry. He has been involved in numerous drug development projects as project leader\, clinical trial manger and/or study director in multiple therapeutic areas\, including\, but not limited to\, oncology\, immunology\, dermatology\, urology\, gynaecology and CNS from early discovery to marketing. His experiences also include due diligence of various projects with primary focus on evaluation of regulatory documents (e.g. pre-IND meeting minutes\, End of Phase I/II meeting minutes) for investors. He is currently leading Venn Life Sciences business in the Netherlands. \n \nLinkedIn: https://www.linkedin.com/in/katsuhiromihara/ \nMatthijs Moerland studied Biomedical Sciences and Molecular Sciences\, and was trained at the department of Cell Biology at Erasmus University Rotterdam. He obtained his PhD investigating lipoprotein metabolism and atherogenesis in humanised animal models. He joined CHDR in 2007 as a Senior Clinical Scientist\, and obtained his registration as clinical pharmacologist. Since 2014\, Matthijs holds a positions as Research Director. He is leading CHDR’s in-house R&D lab\, utilizing cell-based assays for monitoring of drug activity in clinical studies\, and in mechanistic ex vivo studies on primary human cells. In addition\, Matthijs is heading CHDR’s clinical immunoly research group\, with as primary focus the development and application of in vivo immune challenge models (e.g. intravenous and intradermal endotoxin challenges\, neoantigen vaccination\, topical immune challenges)\, and cell-based methodology to monitor immune responses. \n \nLinkedin: https://nl.linkedin.com/in/matthijs-moerland-ba619b17 \nAlfred Luitjens is Global Technical Sales Director at Batavia Biosciences. He has a profound background in development and production of vaccines and viral vectors\, with more than 30 years of experience. He worked in R&D and GMP manufacturing  at Solvay\, DSM Biologics and Crucell (now J&J). He had a management position at the Animal Science Group and was senior manager process architecture at GSK. \n \nLinkedIn: linkedin.com/in/alfred-luitjens-24853011 \nThis workshop offers an unparalleled opportunity for biotech start-ups and scale-ups to learn from the best in the industry. You'll gain meaningful insights through a series of 3 interactive sessions\, including real-world case studies. \nProgram \n13:00 - Walk-In \n13.30 - Opening and welcome \n14:00 - Translation from preclinical to your first clinical trial\, focusing on dose prediction in human - Venn Life Sciences \n15:00 - Entry in to man – early proof-of-mechanism - CHDR \n16:00 - Tech Transfer\, Manufacturing & Scalability - Batavia Biosciences \n17:00 - Networking and drinks on the terrace \nWhy Attend? \nBy attending this workshop\, you will: \n\nGain a comprehensive understanding of the drug development process\nUnderstand how to navigate development complexities\nUnderstand more about creating a robust product development plan\nLearn about the latest trends and innovations in biopharmaceutical development\n\nFinally\, it is an excellent opportunity to network with like-minded professionals\, share experiences\, and foster collaborations. Take the first step towards developing your breakthrough biopharmaceutical product. \nRegister for this live event with your LinkedIn profile information. \nYour path to success starts here!
URL:https://www.vennlifesciences.com/event/roadmap-to-early-clinical-entry-the-devil-is-in-the-detail/
LOCATION:Emmy Noetherweg 2\, Leiden\, Zuid-Holland\, NL\, 2333 BK\, Emmy Noetherweg 2\, Leiden\, 2333 BK\, Netherlands
CATEGORIES:Live Event
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DTSTART;VALUE=DATE:20230615
DTEND;VALUE=DATE:20230616
DTSTAMP:20260409T100727
CREATED:20230510T093317Z
LAST-MODIFIED:20250717T103033Z
UID:1194-1686787200-1686873599@www.vennlifesciences.com
SUMMARY:Webinar - Notified Body Requirements for Drug-Device Combinations: Demystifying Article 117
DESCRIPTION:Notified Body Requirements for Drug-Device Combinations: Demystifying Article 117 \nThe involvement of a notified body is an essential aspect of the regulatory process for combination products covered by Article 117\, as it helps to ensure that the device component of your combination product is safe\, effective\, and compliant with applicable regulations. \nOn 26 May 2021\, the medical device regulation (MDR) took effect. Article 117 of the MDR amends Directive 2001/83/EC\, point 12 of Section 3.2 and requests for (single) integral products the involvement of a Notified Body to assess the conformity of the device part with the relevant general safety and performance requirements (GSPR) of Annex I. \nTherefore\, from 26 May 2021\, new marketing authorization applications for medicinal products with an integral medical device must include a notified body opinion report. \nBut what do you need exactly to receive this Notified Body opinion report? \nKey Learnings:\n- Introduction to Article 117 & Notified Body opinion\n- Selecting the right Notified Body\n- Engaging with the selected Notified Body\n- Best practices in documentation \nSpeaker\nSusanne Fornero-Quaak’s \nAfter completing her pharmacy degree with specialization in formulation development\, Susanne worked for 11 years in the pharmaceutical industry. Her experience includes upstream and downstream processing in bacterial cell culture and ATMP (cell lines) production under GMP conditions\, formulation development for large molecules (plasmid DNA and proteins) including lyophilization\, analytical techniques used for DNA and proteins\, and writing CMC part of registration dossiers. Before joining Venn Life Sciences\, Susanne worked for over 5 years at a notified body (BSI). There she was responsible for reviewing medicinal dossiers for device-drug combinations\, performing consultations for these device-drug combinations with national competent authorities for small molecules and EMA for human blood derivatives or recombinant products as well as reviewing technical files for IVF products and organ preservation solutions (level III reviewer for NBOG codes SMDS1001\, SMDS1008\, SMDS1212). Additionally\, she provided training on drug-device combinations falling under article 117 of the MDR and devices falling under rule 14 (device-drug combination devices) and rule 21 (substance-based devices) of the MDR. \nThis is an online event hosted by Venn Life Sciences - part of hVIVO plc.
URL:https://www.vennlifesciences.com/event/webinar-notified-body-requirements-for-drug-device-combinations-demystifying-article-117/
LOCATION:Leiden
CATEGORIES:Webinar
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BEGIN:VEVENT
DTSTART;TZID=Europe/London:20230601T093000
DTEND;TZID=Europe/London:20230601T180000
DTSTAMP:20260409T100727
CREATED:20230505T112401Z
LAST-MODIFIED:20250717T102246Z
UID:1203-1685611800-1685642400@www.vennlifesciences.com
SUMMARY:Knowledge for Growth
DESCRIPTION:LEARN. CONNECT. DISCOVER. \nThe cream of the Belgian life sciences community attends flanders.bio’s annual Knowledge for Growth business conference\, attracting decision makers from biotech\, pharma and medtech\, agricultural and chemical industry as well as investors\, universities\, topnotch research institutes\, policymakers and competence providers.
URL:https://www.vennlifesciences.com/event/knowledge-for-growth/
LOCATION:Antwerp\, Belgium\, Flanders Meeting & Convention Center Antwerp\, Koningin Astridplein 20\, Antwerp\, 2018\, Belgium
CATEGORIES:Events
ORGANIZER;CN="Get in touch":MAILTO:Peggy.IJzelman@vennlife.com
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DTSTART;TZID=Europe/London:20230523T151500
DTEND;TZID=Europe/London:20230523T181500
DTSTAMP:20260409T100727
CREATED:20230517T130457Z
LAST-MODIFIED:20250717T102643Z
UID:1314-1684854900-1684865700@www.vennlifesciences.com
SUMMARY:TechTalk: Pioneering the Future of ATMP Development & Health Technology Assessment
DESCRIPTION:Organised by LBSP Foundation | Location: BioPartner 1 (J.H oortweg 21) \nWe are thrilled to invite you to join us\, and meet with bright minds\, innovators\, and thought leaders in ATMP (Advanced Therapy Medicinal Products) development and health technology assessment come together to share knowledge\, spark inspiration\, and drive progress in the field. The event is your chance to explore the future of medicine and healthcare through the lens of ATMP science and health technology assessment. Additionally\, this is your opportunity to connect with like-minded individuals and form valuable partnerships during the networking. Join us in shaping the future of ATMP science and health technology assessment by attending TechTalks 2023 and secure your spot today! \nVenn Presentation: “Decoding the variability and the heterogenicity of the allogeneic cell-based medicinal products”
URL:https://www.vennlifesciences.com/event/techtalk-pioneering-the-future-of-atmp-development-health-technology-assessment/
LOCATION:Leiden
CATEGORIES:Events
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BEGIN:VEVENT
DTSTART;TZID=Europe/London:20230516T133000
DTEND;TZID=Europe/London:20230516T170000
DTSTAMP:20260409T100727
CREATED:20230505T111742Z
LAST-MODIFIED:20250717T102117Z
UID:1199-1684243800-1684256400@www.vennlifesciences.com
SUMMARY:Flanders Vaccine
DESCRIPTION:Flanders Vaccine is a strategy-driven non-profit organisation\, supporting the development of immunotherapeutics and vaccines for both prophylactic and therapeutic targets in humans and animals by facilitating the exchange of know-how and complementary innovative technologies between academia and industry. The Flanders Vaccine platform can be seen as an integrated tool that gives rise to more and better partnerships; that prepares us better for future calls for funding; that enables us to network at inspiring meetings and conferences; that generates visibility and attracts significant attention from national and international experts\, stakeholders and organisations.
URL:https://www.vennlifesciences.com/event/flanders-vaccine/
LOCATION:Park Inn by Radisson Leuven\, Martelarenlaan 36\, 3010 Leuven\, Park Inn by Radisson Leuven\, Martelarenlaan 36\, Leuven\, 3010\, Belgium
CATEGORIES:Events
ORGANIZER;CN="Get in touch":MAILTO:Peggy.IJzelman@vennlife.com
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