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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20251104T080000
DTEND;TZID=Europe/Brussels:20251105T200000
DTSTAMP:20260728T025632
CREATED:20250923T113512Z
LAST-MODIFIED:20250923T113512Z
UID:9227-1762243200-1762372800@www.europabio.org
SUMMARY:IHI Brokerage Event 2025
DESCRIPTION:Registration is now open for the IHI Brokerage Event 2025\, which will be held in Brussels\, Belgium on 4-5 November. The event is a prime opportunity for potential applicants to network and start forming consortia for IHI’s next single-stage call for proposals\, which is scheduled for launch in early 2026. \n\n\n\nRegistration is free but obligatory via the event and networking platform. Note that if you signed up to last year’s brokerage platform\, you will receive an e-mail with instructions on how to transfer your profile to the new platform. \n\n\n\nThe brokerage event has been designed to facilitate networking and the formation of consortia for IHI’s next calls for proposals. Find out about the different features of the event… \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/ihi-brokerage-event-2025/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20251027T080000
DTEND;TZID=Europe/Brussels:20251029T200000
DTSTAMP:20260728T025632
CREATED:20250326T110753Z
LAST-MODIFIED:20250326T110753Z
UID:8933-1761552000-1761768000@www.europabio.org
SUMMARY:World Orphan Drug Congress 2025
DESCRIPTION:The World Orphan Drug Congress Europe is the largest and most established event globally for orphan drugs and rare diseases. \n\n\n\nJoin over 2\,000 attendees\, gain insights from 250+ industry leaders\, and connect with over 130 exhibitors as we bring together experts across the entire orphan drug lifecycle\, discussing areas including regulatory affairs and policy to global pricing and cutting-edge gene therapies. \n\n\n\nThe attendees represent the most senior individuals across the industry\, including leaders in R&D\, gene therapy\, rare diseases\, precision/personalised medicine\, genetic disorders\, patient advocacy and engagement\, associations in ATMPs\, investors\, regulatory affairs professions\, governmental bodies\, and more… \n\n\n\nFind out more and get your tickets using the link below. Get 20% off with the code: EUBIO20 \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/world-orphan-drug-congress-2025/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20251015T120000
DTEND;TZID=Europe/Brussels:20251015T210000
DTSTAMP:20260728T025632
CREATED:20250505T110759Z
LAST-MODIFIED:20250814T132321Z
UID:9042-1760529600-1760562000@www.europabio.org
SUMMARY:Biotech & Biomanufacturing Policy Summit
DESCRIPTION:EuropaBio is pleased to host its third Summit focused on biotechnology & biomanufacturing. \n\n\n\nBiotechnology is a critical technology for Europe.  Delivery of innovation into market drives competitiveness\, security\, supply chain resilience plus societal and environmental goals.  Europe must be ambitious and globally aware\, with a focus on securing its biotechnology capability within fast changing global geopolitics. \n\n\n\nThe current Commission has a significant opportunity to set and deliver on the ambition needed. Legislation such as the Biotech Act\, plus the frameworks that we create for sectors including health\, agri-food and manufacturing. \n\n\n\nThe half day Summit brings together EuropaBio Members and stakeholders to understand the ambition needed for legislation\, how the EU and its Member States can deliver and recognition of global positioning needed. \n\n\n\nIt is supported by biotech product displays and EU projects\, plus evening networking reception. It will be followed by a Summit Statement and public webinar hosted in November. \n\n\n\nAgenda: \n\n\n\n12:30 Registration and lunch13:15 Welcome and Keynote session Summit keynotes bring Industry\, Parliament and Commission perspectives to Europe’s ambition for biotech and biomanufacturing and the policy framework currently in action. Commissioner Olivér Várhelyi – Commissioner for Health and Animal Welfare Markus Staempfli – EuropaBio Chair\, Vice President Europe Major Markets & Canada\, CSL Behring MEP Stine Bosse – MEP and co-chair EU Alliance of Biotech and Life Sciences14:00 Panel sessions The current legislative cluster impacting biotechnology and biomanufacturing is in focus for our panel discussions. Stakeholders from across industry\, policy and member states discuss what Europe’s ambition must be and how individual and aligned legislations can deliver.Panel 1 – Enabling EU markets How policy creates markets for biotech products and enables biomanufacturing processes.Panel 2 – Enhancing access How market pathways are vital for product and process commercial viability\, determining speed and scale of access and uptake.Panel 3 – Building the EU ecosystem How knowledge\, skills\, finance and infrastructure deliver on market potential for Europe.17:50 Pre-reception remarks18:00 Reception20:30 Close\n\n\n\nThis event will be accessible by invitation only\, for more information contact us at: communications@europabio.org and c.skentelbery@europabio.org
URL:https://www.europabio.org/event/biotech-biomanufacturing-policy-summit/
CATEGORIES:Biomanufacturing Platform,EuropaBio,Healthcare Biotech,Industrial Biotech,National Associations,SME Platform
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250917T080000
DTEND;TZID=Europe/Brussels:20250918T200000
DTSTAMP:20260728T025632
CREATED:20250618T121730Z
LAST-MODIFIED:20250618T121731Z
UID:9127-1758096000-1758225600@www.europabio.org
SUMMARY:Life Sciences Baltics 2025
DESCRIPTION:Join our Director General Claire Skentelbery at the Life Sciences Baltics 2025 conference where she will be speaking on The EU Biotech Act – leading Europe’s evolution and revolution for competitiveness. \n\n\n\nLife Sciences Baltics is the leading event in the Baltic region\, connecting global life sciences professionals. This event provides unique opportunities for project initiation\, lead generation\, and strategic partnerships through an extensive exhibitor showcase\, insightful conferences\, a dedicated partnering area\, diverse networking formats\, and competitions\, including a startup pitch challenge. \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/life-sciences-baltics-2025/
CATEGORIES:External,Healthcare Biotech,Industrial Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250916T080000
DTEND;TZID=Europe/Brussels:20250917T200000
DTSTAMP:20260728T025632
CREATED:20250618T114107Z
LAST-MODIFIED:20250618T114107Z
UID:9115-1758009600-1758139200@www.europabio.org
SUMMARY:Nordic Rare Disease Summit 2025
DESCRIPTION:The scene has already been set\, the roadmap for change is in our hands. \n\n\n\nTaking place at the heart of Copenhagen on 16 & 17 September\, alongside the Danish Presidency of the European Union\, the 2025 Nordic Rare Disease Summit will gather the leading experts within academia and healthcare professionals\, patients\, decision-makers and industry to discuss solutions; with the joint aspiration of improving the quality of life for people living with rare diseases. \n\n\n\nBuilding on prior summits in 2021 and 2023\, the 2025 summit ‘pushing boundaries for rare’ will centre patient empowerment as a key theme. \n\n\n\nThe expertise of people living with a rare disease must be acknowledged as a resource from the level of individual patients to that of the community\, and as a foundation for policymaking in the Nordics and the European Union. Together we can do more. \n\n\n\n \n\n\n\n \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/nordic-rare-disease-summit-2025/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250902T080000
DTEND;TZID=Europe/Brussels:20250904T200000
DTSTAMP:20260728T025632
CREATED:20250618T115945Z
LAST-MODIFIED:20250618T120020Z
UID:9118-1756800000-1757016000@www.europabio.org
SUMMARY:Advanced Therapies Europe 2025
DESCRIPTION:Now in its 5th year\, Advanced Therapies Europe 2025 is an intentionally intimate event — limited to just 500 senior-level decision-makers — to ensure every conversation drives outcomes. Held in Barcelona\, at the heart of Europe’s fast-growing biotech ecosystem\, this is where strategic connections ignite progress and insights lead to action. Whether you’re here to invest\, scale\, partner\, or launch\, ATE 2025 gives you the platform to make it happen. \n\n\n\n \n\n\n\nEuropaBio Director General Dr Claire Skentelbery will take the stage in our Opening Plenary to explore the state of the CGT industry and what Europe must do now to secure its global leadership. With U.S. support for scientific innovation under pressure\, the time is now for Europe to sharpen its edge in scalability\, affordability\, and patient access. \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/advanced-therapies-europe-2025/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250701T150000
DTEND;TZID=Europe/Brussels:20250701T170000
DTSTAMP:20260728T025632
CREATED:20250618T120817Z
LAST-MODIFIED:20250618T120910Z
UID:9122-1751382000-1751389200@www.europabio.org
SUMMARY:Nordic Rare Disease Roadmap Launch at the European Parliament
DESCRIPTION:Join us at the European Parliament on Tuesday 1 July\, from 15:00 to 17:00. Members of the European Parliament Stine Bosse (Renew Europe\, Denmark) and Maria Guzenina (Socialists and Democrats\, Finland) are hosting the event\, which coincides with Denmark assuming the Presidency of the Council of the European Union. This European Parliament event will bring together key stakeholders to mark an important step forward in our shared work to drive action for the more than 1 million people living with rare diseases in the Nordics and more than 30 million people living with rare diseases in Europe!  \n\n\n\nOur Director General Dr Claire Skentelbery will be speaking on the panel Rare diseases in the EU agenda: A call for a collective response. \n\n\n\nThis event is supported by the Nordic Rare Disease group – namely EURORDIS\, SBONN\, Sjældne Diagnoser\, Novo Nordisk\, Takeda\, Alexion\, Sobi\, UCB\, EFPIA\, EuropaBio\, and EUCOPE. \n\n\n\n\nRegister Here
URL:https://www.europabio.org/event/nordic-rare-disease-roadmap-launch-at-the-european-parliament/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250513T160000
DTEND;TZID=Europe/Brussels:20250513T180000
DTSTAMP:20260728T025632
CREATED:20250422T074400Z
LAST-MODIFIED:20250430T072534Z
UID:9000-1747152000-1747159200@www.europabio.org
SUMMARY:Patient BioForum 2025
DESCRIPTION:The theme of the Patient BioForum 2025 is From discovery to access: towards a patient-centric health European ecosystem. \n\n\n\nThe event is hosted by MEP András Tivadar Kulja\, who will hold a keynote speech\, and concluding remarks will be given by MEP Stine Bosse. \n\n\n\nThe panel discussion is moderated by Dr. Nicholas Whyte (Senior Director – APCO) and includes: \n\n\n\nRosa Castro (Public Affairs Director\, EURORDIS)\,  \n\n\n\nLeire Solis\, (Health Policy and Advocacy Director\, IPOPI)\,  \n\n\n\nSolène Jouan (Policy Officer\, European Patients’ Forum)\, \n\n\n\nIrene de Cara Torres (Head of Policy and Government Affairs International\, CSL Behring)\, \n\n\n\nDr. Claire Skentelbery (Director General\, EuropaBio)\, \n\n\n\nRainer Becker (Director SANTE.D Medical Products and Innovation). \n\n\n\n \n\n\n\nThe event gathers patients organisations\, industry leaders and representatives of EU institutions to discuss how the regulatory framework and future legislations (General Pharmaceutical Legislation\, EU Biotech Act and Critical Medicines Act) will support innovation\, availability\, and access to medicines for EU patients. \n\n\n\nEuropaBio’s Patient BioForum aims to facilitate the exchange of views and expertise on scientific\, regulatory\, and policy issues between patient organisations\, the biopharmaceutical industry and policy makers. \n\n\n\nFor more information\, please contact Beatrice Rocco: b.rocco@europabio.org \n\n\n\nRegistrations for people that do not have a badge to access the European Parliament will close at 12:00 on 6 May 2025. People that have a badge can register beyond this date.  \n\n\n\n \n\n\n\n\nRegister Here
URL:https://www.europabio.org/event/patient-bioforum-2025/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250507T000000
DTEND;TZID=Europe/Brussels:20250508T235959
DTSTAMP:20260728T025632
CREATED:20250303T145152Z
LAST-MODIFIED:20250303T145236Z
UID:8834-1746576000-1746748799@www.europabio.org
SUMMARY:Knowledge for Growth 2025
DESCRIPTION:Mark your calendar for Knowledge for Growth 2025\, Europe’s premier life sciences conference\, taking place on 8 May 2025 in the dynamic city of Antwerp\, Belgium! \n\n\n\nConnect with over 1\,000 life sciences professionals from 500+ companies and organisations\, including decision-makers from biotech\, pharma\, MedTech\, AgTech\, and healthtech\, as well as investors\, universities\, research institutes\, policymakers\, and service providers. \n\n\n\nImmerse yourself in an action-packed programme offering exclusive insights into the global and regional life sciences landscape\, one-to-one partnering\, a vibrant trade fair\, and countless networking opportunities. \n\n\n\nDon’t miss the chance to elevate your knowledge and expand your network at Knowledge for Growth 2025! \n\n\n\nUSE CODE: KFG2025CLUSTER15 FOR A 15% DISCOUNT \n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/knowledge-for-growth-2025/
CATEGORIES:Biomanufacturing Platform,External,Healthcare Biotech,Industrial Biotech,National Associations
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250403T133000
DTEND;TZID=Europe/Brussels:20250403T150000
DTSTAMP:20260728T025632
CREATED:20250224T145353Z
LAST-MODIFIED:20250224T145353Z
UID:8810-1743687000-1743692400@www.europabio.org
SUMMARY:Unlocking efficiency through reliance: Navigating the EMA post-authorization framework
DESCRIPTION:This joint webinar\, organised in partnership between the EMA and the industry\, aims to provide a platform for discussion and awareness on current and future EMA post-authorization framework\, including variations and renewals. This event builds up on last year’s session: “Regulatory Reliance Tools Unveiled – A Practical Guide by EMA.” \n\n\n\nThis year\, we will further explore how EMA assessment outputs can support regulatory reliance pathways\, helping to streamline the approval of variations (CMC\, clinical/safety) efficiently and sustainably. \n\n\n\nSpearheaded by EMA\, with the participation of WHO and global regulators\, the webinar will: \n\n\n\n\nExplain EMA’s variations and renewals process.\n\n\n\nDescribe the purpose and content of assessment document outputs and their relevance for regulatory reliance.\n\n\n\nAddress participant questions to enhance understanding and application of these tools.\n\n\n\n\n\nMore Info Here
URL:https://www.europabio.org/event/unlocking-efficiency-through-reliance-navigating-the-ema-post-authorization-framework/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250129T183000
DTEND;TZID=Europe/Brussels:20250129T203000
DTSTAMP:20260728T025632
CREATED:20241217T125548Z
LAST-MODIFIED:20250128T102313Z
UID:8543-1738175400-1738182600@www.europabio.org
SUMMARY:A Driver of European Competitiveness: The Future of European Biotech
DESCRIPTION:EuropaBio\, the European association representing Bioindustries\, will host an evening reception co-hosted by MEP Stine Bosse (Vice-Chair\, SANT) and MEP Eszter Lakos (Member\, ITRE)\, to discuss the role of the European biotech sector in making the European industry more competitive. \n\n\n\nAmbassador Søren Jacobsen\, Deputy Permanent Representative of Denmark to the EU\, and Kristin Schreiber\, Director at DG GROW\, Klaus Berend\, Director SANTE will share some remarks on their approach to the biotech sector in the new mandate. \n\n\n\nThis event is only open to EuropaBio members & invited guests\, to find out more about EuropaBio membership\, contact us through our website here.
URL:https://www.europabio.org/event/a-driver-of-european-competitiveness-the-future-of-european-biotech/
CATEGORIES:Biomanufacturing Platform,EuropaBio,Healthcare Biotech,Industrial Biotech,SME Platform
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20250128T140000
DTEND;TZID=Europe/Brussels:20250128T180000
DTSTAMP:20260728T025632
CREATED:20241126T083629Z
LAST-MODIFIED:20241126T083631Z
UID:8485-1738072800-1738087200@www.europabio.org
SUMMARY:EU Health Summit
DESCRIPTION:Healthy populations are essential for Europe to achieve its vision of a secure\, competitive\, and prosperous continent. Yet\, European health systems are navigating a perfect storm: ageing populations\, rising chronic diseases\, and a health workforce under strain. European societies are facing combined cost-of-living\, geopolitical\, and climate crises with significant implications for healthcare. \n\n\n\nAmid these challenges\, we must not lose sight of the extraordinary era we are living in—one of rapidly advancing science and innovation\, transforming health and unlocking new possibilities for Europe’s present and future generations. \n\n\n\nKeeping the health sector high on the political agenda is essential for the well-being of Europeans\, a resilient workforce\, the growth of the EU economy\, and the security of Europe. This is why\, during this EU mandate\, we need a robust and integrated strategy for health policy. \n\n\n\nWhat needs to be done in practice? \n\n\n\nJoin the EU Health Summit on 28 January to help shape a roadmap for a healthier Europe. \n\n\n\n\nRegister Here
URL:https://www.europabio.org/event/eu-health-summit/
CATEGORIES:EuropaBio,External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20241022T080000
DTEND;TZID=Europe/Brussels:20241025T170000
DTSTAMP:20260728T025632
CREATED:20240611T071159Z
LAST-MODIFIED:20240611T071200Z
UID:7930-1729584000-1729875600@www.europabio.org
SUMMARY:World Orphan Drug Congress Europe 2024
DESCRIPTION:The World Orphan Drug Congress Europe is the largest and most established orphan drug & rare disease event worldwide. Meet over 2000 attendees\, hear from 250 leading speakers\, and connect with 130 exhibitors as we bring together experts from the start-to-finish of orphan drugs. From regulation and policy to global pricing and gene therapy\, the Congress has it covered. \n\n\n\nOur attendees include the most senior individuals across the industry\, including; R&D\, Gene Therapy and Rare diseases\, Precision/Personalised Medicine\, Genetic Disorders\, Patient Advocacy and Engagement\, Associations in ATMPs\, Investors\, Regulatory Affairs Professionals\, Governmental Bodies and many more … \n\n\n\nUse code “EUBIO20” to save an additional 20% off the Pharma/Biotech and Standard packages.
URL:https://www.europabio.org/event/world-orphan-drug-congress-europe-2024/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20241008T100000
DTEND;TZID=Europe/Brussels:20241010T180000
DTSTAMP:20260728T025632
CREATED:20240828T135105Z
LAST-MODIFIED:20240828T135930Z
UID:8158-1728381600-1728583200@www.europabio.org
SUMMARY:CPHI Milan
DESCRIPTION:EuropaBio is pleased to partner with CPHI Milan 2024\, the biggest international pharmaceutical industry event for the thirty fifth anniversary edition. This year’s edition held from the 8th to the 10th of October in Fiera Milano\, Italy promises to a packed agenda with over 150 expert international speakers with over 100 content sessions. \n\n\n\nJoin our Director General Dr Claire Skentelbery this year where she will be speaking on the 9th of October to discuss how cultivated meat has the potential to revolutionise biologic manufacturing. Join her in Hall 3 – 3F97 at 16:15 on 09/10/2024 to find out more. \n\n\n\n \n\n\n\n\nFind Out More & Register Here
URL:https://www.europabio.org/event/cphi-milan/
CATEGORIES:Biomanufacturing Platform,External,Healthcare Biotech,Industrial Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20241002T170000
DTEND;TZID=Europe/Brussels:20241002T193000
DTSTAMP:20260728T025632
CREATED:20240827T080153Z
LAST-MODIFIED:20240827T080535Z
UID:8151-1727888400-1727897400@www.europabio.org
SUMMARY:Enhancing Europe's Pharma and Biotech Competitiveness and Open Strategic Autonomy
DESCRIPTION:Join our Director General Dr Claire Skentelbery on 2 October 2024 where she will be speaking at the Novartis & BritCham event “Enhancing Europe’s Pharma and Biotech Competitiveness and Open Strategic Autonomy”. \n\n\n\n\nFind Out More & Register Here
URL:https://www.europabio.org/event/enhancing-europes-pharma-and-biotech-competitiveness-and-open-strategic-autonomy/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240710T080000
DTEND;TZID=Europe/Brussels:20240711T170000
DTSTAMP:20260728T025632
CREATED:20240531T135225Z
LAST-MODIFIED:20240531T135227Z
UID:7893-1720598400-1720717200@www.europabio.org
SUMMARY:CURIOUS­ FUTURE INSIGHT™ CONFERENCE
DESCRIPTION:Over the millennia science & technology have steadily advanced\, but key unsolved challenges remain\, and much more is possible. The Curious – Future Insight™ Conference brings together some of the world’s brightest scientists and most accomplished innovators to present their work and explore the future of science and technology\, solving the challenges of today and enabling the dreams of a better tomorrow. \n\n\n\nThe Curious – Future Insight™ conference featurestop speakers and Nobel laureates from all over theworld\, among them: \n\n\n\n\nEmmanuelle Charpentier\, MPI (2018)\n\n\n\nSteven Chu\, Stanford University (2024)\n\n\n\nRobert Langer\, MIT (2024)\n\n\n\nSatya Nadella\, CEO Microsoft (2018)\n\n\n\nUğur Şahin\, CEO BioNTech (2024)\n\n\n\nRandy Schekman\, Berkeley (2024)\n\n\n\nThomas C. Südhof\, Stanford University (2024\, 2022)\n\n\n\nCraig Venter\, Craig Venter Institute (2018)
URL:https://www.europabio.org/event/curious-future-insight-conference/
CATEGORIES:Biomanufacturing Platform,External,Healthcare Biotech,Industrial Biotech,SME Platform
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240416T083000
DTEND;TZID=Europe/Brussels:20240416T120000
DTSTAMP:20260728T025632
CREATED:20240326T082922Z
LAST-MODIFIED:20240326T083218Z
UID:7614-1713256200-1713268800@www.europabio.org
SUMMARY:RARE DISEASES FORUM 2024
DESCRIPTION:Against the backdrop of the Belgian EU Council Presidency\, the Rare Diseases Forum 2024 brings together senior leaders from across patient organisations\, industry and policy to address how and why innovation in tackling rare diseases can support the EU’s competitiveness agenda. \n\n\n\n \n\n\n\nAbout ‘The Rare Diseases Forum 2024: Securing Europe’s Competitiveness in R&D for people living with rare diseases’ features keynotes and panel discussions with a focus on the EU’s role in enhancing competitiveness in life sciences\, fostering investment in the rare diseases sector\, and examining the benefits of a competitive agenda for those with rare diseases.  \n\n\n\nThe event is convened by Global Counsel on behalf of the forum partners\, EURORDIS\, RaDiOrg\, EFPIA\, Eucope\, EuropaBio\, Pharma.be\, UCB\, Novo Nordisk\, Sanofi & Takeda.
URL:https://www.europabio.org/event/rare-diseases-forum-2024/
CATEGORIES:EuropaBio,External,Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240307T130000
DTEND;TZID=Europe/Brussels:20240307T143000
DTSTAMP:20260728T025632
CREATED:20240209T095401Z
LAST-MODIFIED:20240306T151454Z
UID:7385-1709816400-1709821800@www.europabio.org
SUMMARY:EuropaBio Webinar – How will the revision EU General Pharmaceutical Legislation impact Europe’s innovation ecosystem and biotechnology companies?
DESCRIPTION:Join us on 7 March to discuss the impact of revision of the EU’s General Pharmaceutical Legislation (GPL) on Europe’s innovation ecosystem and biotechnology companies. \n\n\n\nFollowing the publication on 24 January 2024 of a new study analysing the expected impact of the GPL on the biotechnology innovation ecosystem\, EuropaBio is delighted to invite you to attend its exclusive webinar to discuss the consequences of this landmark legislation for the future of innovation in healthcare in Europe\, EU patients and economies within a global race towards health security and competitiveness. \n\n\n\nThe event will start with a presentation of the study by Charles Rivers Associates and will be followed by a panel discussion featuring leading voices of the European biotechnology ecosystem to discuss the impact of the proposed legislation and its consequences on the development of breakthrough medicines for EU patients. \n\n\n\nThe webinar will take place on Thursday 7 March at 13.00 CET. If you wish to attend\, please register below. \n\n\n\nAgenda: \n\n\n\n\nWelcome & Introduction: 13:00 – 13:05\, Dr Claire Skentelbery\, Director General EuropaBio\n\n\n\n\n\nReport Presentation and Q&A: 13:05 – 13:30\, Antun Sablek & Tim Wilsdon\, Charles River Associates\n\n\n\nPanel Discussion and Q&A: 13:30 – 14:25\, Panelists: John James Ricketts\, Noel Minnis\, Thomas Bols\, Tineke Van hooland\, Wojciech Nowak and Yordan Aleksandrov. Moderated by Dr Claire Skentelbery.\n\n\n\nConcluding Remarks: 14:25 – 14:30 Dr Claire Skentelbery\, Director General EuropaBio\n\n\n\n\n \n\n\n\nSpeakers: Moderated by Dr Claire Skentelbery\, EuropaBio \n\n\n\n\nAntun Sablek\, Charles River Associates\n\n\n\nJohn James Ricketts\, Eli Lilly\n\n\n\nNoel Minnis\, Takeda\n\n\n\nThomas Bols\, PTC Therapeutics\n\n\n\nTim Wilsdon\, Charles River Associates\n\n\n\nTineke Van hooland\, Bio.be\n\n\n\nWojciech Nowak\, Novartis\n\n\n\nYordan Aleksandrov\, Pfizer\n\n\n\n\n\nRegister here
URL:https://www.europabio.org/event/europabio-webinar-how-will-the-revision-eu-general-pharmaceutical-legislation-impact-europes-innovation-ecosystem-and-biotechnology-companies/
CATEGORIES:EuropaBio,Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240229T090000
DTEND;TZID=Europe/Brussels:20240301T170000
DTSTAMP:20260728T025632
CREATED:20240214T085311Z
LAST-MODIFIED:20240214T100345Z
UID:7415-1709197200-1709312400@www.europabio.org
SUMMARY:International Congress on Rare Diseases and Orphan Drugs 2024
DESCRIPTION:Navigating the Uncharted: Advancements\, Collaborations\, and Hope in Rare Diseases \n\n\n\nSupported by EuropaBio \n\n\n\n \n\n\n\nAbout the event: \n\n\n\nEmbrace the extraordinary journey into the world of rare diseases at our groundbreaking International Congress\, where innovation\, collaboration\, and hope converge! \n\n\n\nThe International Congress on Rare Diseases and Orphan Drugs is organized by Rare Diseases Greece (RDG)\, member of EURORDIS-Rare Diseases Europe and Boussias Events. \n\n\n\nFollowing the success of the previous years and having advanced the policy agenda on both a national and international level\, the Organizing Committee – consisting of Rare Diseases Greece (RDG)\, the 30-member umbrella organization that represents the country’s rare disease community\, brings together all the key initiatives and stakeholders currently shaping the rare disease landscape with the aim to set a course for the future of rare diseases. \n\n\n\nAttendance details: \n\n\n\nThursday\, 29.02.2024 (Hybrid | Technopolis City of Athens Gasholder 1 – Auditorium “Miltiadis Evert”) & Friday\, 01.03.2024 (Digital) \n\n\n\n \n\n\n\n\nRegister here\n\n\n\n\n \n\n\n\n\nFind out more here
URL:https://www.europabio.org/event/international-congress-on-rare-diseases-and-orphan-drugs-2024/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240214T080000
DTEND;TZID=Europe/Brussels:20240214T170000
DTSTAMP:20260728T025632
CREATED:20240130T125205Z
LAST-MODIFIED:20240130T125207Z
UID:7333-1707897600-1707930000@www.europabio.org
SUMMARY:Europe Rare Disease Summit 2024
DESCRIPTION:How to improve and learn about Government Plans\, Access & Financing\, Clinical Research and Innovation\, Artificial Intelligence and Data\, and Social & Patient. \n\n\n\nJoin our very own Healthcare Policy Senior Manager\, Adrien Samson in Madrid where he will be speaking in the panel “Innovation\, Funding and Access to Orphan Drugs: Challenges and Opportunities” between 12:15 and 13:00. \n\n\n\n \n\n\n\nWe are thrilled to announce the eagerly awaited second edition of the Europe Rare Disease Summit\, set to take place in February. Joining forces from all corners of Europe\, this prestigious event brings together leading researchers\, healthcare professionals\, patient advocates\, policymakers\, industry experts\, and rare disease patients and families. \n\n\n\nThe summit emphasizes the power of collaboration and solidarity in facing rare diseases. Together\, we can accelerate research\, enhance patient care\, and improve outcomes\, offering a brighter future for those affected by rare diseases. \n\n\n\nKey Objectives: \n\n\n\nEmpowering Patients: Putting patients at the heart of our efforts\, we strive to enhance their access to quality care and support\, while advocating for their rights and unique challenges. \n\n\n\nAdvancing Research: Renowned scientists will present groundbreaking discoveries\, fostering cross-disciplinary collaboration to propel rare disease research forward. \n\n\n\nBuilding Collaborative Networks: A platform for stakeholders to connect\, exchange ideas\, and form strategic partnerships\, bridging gaps in research\, treatment\, and support. \n\n\n\nInfluencing Policy: By engaging policymakers\, we seek to drive positive changes and better support the rare disease community. \n\n\n\nEngaging Program Highlights: Expect a dynamic lineup of keynote speeches\, interactive workshops\, panel discussions and networking opportunities. Share experiences\, learn from experts\, and inspire change. \n\n\n\nLocation and Dates: Prepare to be inspired in the vibrant setting of Madrid on February 14th. \n\n\n\nWho will Attend: \n\n\n\nRare Disease AdvocatesResearchers and ScientistsHealthcare ProfessionalsIndustry LeadersPolicymakers and Government RepresentativesPharmaceutical and Biotech CompaniesInvestors and Venture CapitalistsAcademics and Students
URL:https://www.europabio.org/event/europe-rare-disease-summit-2024/
CATEGORIES:External,Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240124T120000
DTEND;TZID=Europe/Brussels:20240124T150000
DTSTAMP:20260728T025632
CREATED:20240109T104014Z
LAST-MODIFIED:20240116T095205Z
UID:7234-1706097600-1706108400@www.europabio.org
SUMMARY:EU pharmaceutical legislation - Europe’s biotech innovation in the balance?
DESCRIPTION:Event agenda \n\n\n\n12:00: Registration opens \n\n\n\n12:30: Panel starts \n\n\n\n13:45: Panel close and networking lunch \n\n\n\n15:00: Close \n\n\n\nConfirmed Speakers \n\n\n\nTomislav Sokol MEPMember SANT Committee\, European Parliament \n\n\n\nHilde StevensCo-director\, Institute for Interdisciplinary Innovation in Healthcare (I3H)\, ULB \n\n\n\nKristin ThompsonChief Operating Officer\, eureKARE \n\n\n\nVivian TsevelekiChief Operating Officer\, theraCell \n\n\n\nMore to be announced soon \n\n\n\nIntroduction \n\n\n\nIn April 2023\, the European Commission adopted a proposal for a new Directive and a new Regulation\, aimed at revising and replacing the existing General Pharmaceutical Legislation (GPL). The proposal focuses on modernising the pharmaceutical sector with a patient-centred approach\, while also fully supporting an innovative and competitive industry. \n\n\n\nThrough the proposal\, the EU aims to offer an attractive and innovation-friendly environment for research\, development\, and production of medicines in Europe. The EU plans to create this environment by promoting world-class innovation\, governed by stable and consistent rules that keep pace with innovation and which increase competitiveness while reducing red tape and costs. \n\n\n\nOne of the sectors impacted by the proposal is that of biotechnology\, which has been instrumental in the discovery and development of therapies\, diagnostics\, vaccines and\, most importantly\, advanced medicines. These ‘next generation medicines’ are delivered through a complex and interdependent biotechnology ecosystem\, where companies of all sizes contribute to establishing a pathway to patients. \n\n\n\nJoin this Euractiv Hybrid Conference to discuss Europe’s biotech innovation in light of the EU’s reform of the General Pharmaceutical Legislation.  \n\n\n\nQuestions to be discussed include: \n\n\n\n\nHow can Europe’s biotechnology industry maintain its competitiveness in the global medical market?\n\n\n\nHow can we establish a framework that fosters the growth of small biotech innovators?\n\n\n\nWhat are the reactions of investors to the challenges faced by small biotech companies\, and how do these reactions influence the trajectory of innovation in the biotech industry?\n\n\n\nWhat strategies can be employed to establish a successful innovation pathway for biotech companies\, while considering and aligning with the objectives of the reformed GPL?
URL:https://www.europabio.org/event/eu-pharmaceutical-legislation-europes-biotech-innovation-in-the-balance/
CATEGORIES:All,EuropaBio,External,Healthcare Biotech,SME Platform
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20240110T080000
DTEND;TZID=Europe/Brussels:20240125T170000
DTSTAMP:20260728T025632
CREATED:20231213T130812Z
LAST-MODIFIED:20231213T131255Z
UID:7175-1704873600-1706202000@www.europabio.org
SUMMARY:IHI Call Days - Calls 6 & 7
DESCRIPTION:The IHI Call Days are your one-stop-shop to get detailed information on our calls for proposals and network with potential partners for your consortium. \n\n\n\nIHI call 7 (single-stage) – info sessions\n\n\n\n10-12 January 2024 \n\n\n\nCall 7\, topic 1: Improving clinical management of heart disease from early detection to treatmentWednesday 10 January | 10:30-11:30 \n\n\n\nCall 7\, topic 2: User-centric technologies and optimised hospital workflows for a sustainable healthcare workforceWednesday 10 January | 14:30-15:30 \n\n\n\nIHI rules and procedures for single-stage callsThursday 11 January | 10:30-11:30 \n\n\n\nCall 7\, topic 3: Clinical validation of biomarkers for diagnosis\, monitoring disease progression and treatment responseThursday 11 January | 14:30-15:30 \n\n\n\nManaging the financial aspects of proposals for single-stage callsFriday 12 January | 10:30-11:30 \n\n\n\nIHI call 6 (two-stage) – info sessions\n\n\n\n15-16 January 2024 \n\n\n\nIHI rules and procedures for two-stage callsMonday 15 January | 14:30-15:30 \n\n\n\nCall 6\, topic 2: Development of practical guidance and recommendations for using real world data/real world evidence in healthcare decision-makingTuesday 16 January | 10:30-11:30 \n\n\n\nCall 6\, topic 1: Support healthcare system resilience through a focus on persistency in the treatment of chronic diseasesTuesday 16 January | 14:30-15:30 \n\n\n\nIHI call 7 (single-stage) – pitching sessions\n\n\n\n23-25 January 2024 \n\n\n\nCall 7\, topic 1: Improving clinical management of heart disease from early detection to treatmentTuesday 23 January | 14:30-16:00 \n\n\n\nCall 7\, topic 2: User-centric technologies and optimised hospital workflows for a sustainable healthcare workforceWednesday 24 January | 14:30-16:00 \n\n\n\nCall 7\, topic 3: Clinical validation of biomarkers for diagnosis\, monitoring disease progression and treatment responseThursday 25 January | 14:30-16:00
URL:https://www.europabio.org/event/ihi-call-days-calls-6-7/
CATEGORIES:Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20231130T143000
DTEND;TZID=Europe/Brussels:20231130T160000
DTSTAMP:20260728T025632
CREATED:20231018T092656Z
LAST-MODIFIED:20231018T113625Z
UID:7003-1701354600-1701360000@www.europabio.org
SUMMARY:EuropaBio Patient BioForum 2023 Roundtable on Advancing Solutions for Unmet Medical Needs
DESCRIPTION:Hybrid Event | Invitation Only \n\n\n\n\n\nEuropaBio’s Patient BioForum meets annually to facilitate the exchange of views and expertise on scientific\, regulatory\, and policy issues between patient organisations and the biopharmaceutical industry. \n\n\n\nIn recent years\, unmet medical needs have been at the core of Europe’s pharmaceutical and public health policies. To address unmet medical needs (UMN)\, the Commission proposed as part of the revision of the EU General Pharmaceutical Legislation (GPL) to introduce a definition of UMN and a definition of high UMN. Under the Commission’s proposals\, all orphan products would qualify as addressing UMN but only a subset of products would meet the HUMN criteria. The Commission’s proposals on UMN and especially HUMN received mixed reactions from patient organisations and negative reactions from the industry. \n\n\n\nOn 1 December 2022\, EuropaBio organised a Patient BioForum which brought together industry and patient organisations to discuss the topic of UMN in view of reaching a common understanding on UMN. Those discussions revealed shared interests and concerns with the possible approach to UMN in the EU Pharmaceutical Legislation. The discussions were followed by a report which outlined recommendations to policymakers to enable Europe to address the challenge of UMN. \n\n\n\nWith the proposals now presented and being negotiated by the European Parliament and the Council\, the 2023 Patient BioForum is an opportunity to build on the 2022 Patient BioForum to foster exchanges between patient groups and industry on UMNs\, including expectations from the legislation and beyond. The 2023 Patient BioForum will also be an opportunity to issue multi-stakeholder recommendations to policymakers to ensure the GPL is fit for purpose to address patients need and support innovation.   \n\n\n\n \n\n\n\nProgramme \n\n\n\nThe 2023 Patient BioForum will be held in a roundtable format under Chatham House Rule. A wide range of stakeholders representing patients\, regulators\, policy-makers\, and industry will be invited to take part in the roundtable. All participants will be invited to take an active part in the discussion to bring their unique perspective. The roundtable will be followed by a report to summarise the discussions. \n\n\n\n1. Introductions \n\n\n\n2. Legislating Unmet Medical Needs: Perspectives from the European Commission and the European Parliament \n\n\n\n3. Roundtable topic 1:  How Can the EU Pharmaceutical Legislation Help Stimulate Patient-Centric Innovation? \n\n\n\n4. Roundtable topic 2: How can Europe Incentivise R&D for UMN and Underserved Areas? \n\n\n\n5. Conclusions \n\n\n\nIf you would like to attend\, please contact Adrian Lincoln\, a.lincoln@europabio.org
URL:https://www.europabio.org/event/europabio-patient-bioforum-2023-roundtable-on-advancing-solutions-for-unmet-medical-needs/
CATEGORIES:EuropaBio,Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20231106T153000
DTEND;TZID=Europe/Brussels:20231106T163000
DTSTAMP:20260728T025633
CREATED:20231013T105949Z
LAST-MODIFIED:20231013T105951Z
UID:6985-1699284600-1699288200@www.europabio.org
SUMMARY:BIO Europe 2023
DESCRIPTION:The European Pharmaceutical Legislation – Will it keep the light on for biotech in Europe? \n\n\n\nJoin our Director General\, Dr. Claire Skentelbery on the 6th of November in Munich for her panel discussing what the legislation brings\, its potential impact on businesses and what needs to be done to change the legislation in its journey to a final version\, that it works for both\, the biotech ecosystem\, maintaining innovation pipelines\, and patients.
URL:https://www.europabio.org/event/bio-europe-2023/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20231101T080000
DTEND;TZID=Europe/Brussels:20231102T170000
DTSTAMP:20260728T025633
CREATED:20231013T082312Z
LAST-MODIFIED:20231013T082314Z
UID:6977-1698825600-1698944400@www.europabio.org
SUMMARY:World Orphan Drug Congress
DESCRIPTION:The World Orphan Drug Congress is the largest and most established orphan drugs & rare diseases meeting of its kind across the globe. \n\n\n\nJoin our Director General\, Dr. Claire Skentelbery on the 1st of November for her Keynote Panel: How to navigate the new legislation to enable orphan drug developers to stay innovative and profitable in Europe. \n\n\n\nAs well as on the 2nd on November for her Panel: How to enable SME’s to obtain greater market access.
URL:https://www.europabio.org/event/world-orphan-drug-congress/
CATEGORIES:External,Healthcare Biotech
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20231023T124000
DTEND;TZID=Europe/Brussels:20231023T141000
DTSTAMP:20260728T025633
CREATED:20231012T114428Z
LAST-MODIFIED:20231012T115640Z
UID:6973-1698064800-1698070200@www.europabio.org
SUMMARY:TOPRA Symposium 2023: advancing global healthcare together
DESCRIPTION:Session: Update on EU new regulatory legislation and a view from different angles \n\n\n\nJoin our very own Valentin Plouchard who will be speaking at the TOPRA Annual Symposium in Lisbon on the 23rd of October.
URL:https://www.europabio.org/event/topra-symposium-2023-advancing-global-healthcare-together/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20231011T133000
DTEND;TZID=Europe/Brussels:20231011T150000
DTSTAMP:20260728T025633
CREATED:20230920T110911Z
LAST-MODIFIED:20230920T110912Z
UID:6861-1697031000-1697036400@www.europabio.org
SUMMARY:SMEs in a Changing World: The Impact of the Revision of the Pharmaceutical Legislation on Europe’s innovative SMEs
DESCRIPTION:In April 2023\, the European Commission published new legislative proposals to revise the EU’s long-standing pharmaceutical legislation and ensure it can meet the challenges of the 21st century. The revision will redefine the regulatory framework for medicines and have a significant impact on the global innovation ecosystem. \n\n\n\nAs emerging and small companies have become innovation drivers\, responsible for over two-thirds of the R&D pipeline that will become the medicines of tomorrow\, changing the rule book that has helped build Europe’s small company ecosystem over the last 20 years is going to have consequences for start-ups\, emerging and small companies looking to first enter the market but also on mid-size companies looking for growth opportunities in Europe. \n\n\n\nThis event will be an opportunity to highlight the role of small and mid-size companies in developing medicines for patients\, assess the foreseeable impacts of the revision on those companies\, and hear directly from them what they need from the revision to continue their journey in Europe.
URL:https://www.europabio.org/event/smes-in-a-changing-world-the-impact-of-the-revision-of-the-pharmaceutical-legislation-on-europes-innovative-smes/
CATEGORIES:EuropaBio,External,Healthcare Biotech,SME Platform
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BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20230517T160000
DTEND;TZID=Europe/Brussels:20230517T163000
DTSTAMP:20260728T025633
CREATED:20230516T082719Z
LAST-MODIFIED:20230516T082807Z
UID:6226-1684339200-1684341000@www.europabio.org
SUMMARY:EU Healthcare and Pharmaceutical Policy in 2023: What You Need to Know
DESCRIPTION:From the ongoing revision of the EU pharmaceutical legislation package and addressing critical supply issues to the impact of the recent Medical Device Regulation transition period extension\, the challenges in EU healthcare and pharmaceutical policy are ever-evolving. Plus\, with the implementation of critical files\, such as the European Health Data Space (EHDS) and the Substances of Human Origin (SoHo) regulation\, it’s vital for organizations in this market to stay up-to-date with the latest policy and regulatory developments. \n\n\n\nTune in on May 17 at 4 pm CEST | 10 am EDT for a 30-minute recorded webinar that will delve into the latest updates in legislation and regulation that are shaping the future of healthcare\, pharmaceutical\, and medical device industries in Europe to help you navigate the next steps in this policy landscape. \n\n\n\nExperts will discuss: \n\n\n\n\nThe ongoing revision of EU pharmaceutical legislation\n\n\n\nTackling critical supply issues in pharmaceuticals and medical devices\n\n\n\nThe impact of the Medical Device Regulation transition period extension\n\n\n\nProposed and upcoming critical files you should be monitoring\n\n\n\nThe future of EU healthcare policy in 2023 and beyond\n\n\n\n\nFeatured speakers: \n\n\n\n\nAdrien Samson\, healthcare policy & public affairs senior manager\, EuropaBio\n\n\n\nJelle Verheij\, policy analyst – health and pharmaceuticals policy\, EU Issue Tracker\n\n\n\nModerator: Geraint Edwards\, managing director of FiscalNote Brussels\n\n\n\n\n\nMore Details
URL:https://www.europabio.org/event/eu-healthcare-and-pharmaceutical-policy-in-2023-what-you-need-to-know/
CATEGORIES:External,Healthcare Biotech
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END:VEVENT
BEGIN:VEVENT
DTSTART;TZID=Europe/Brussels:20230418T150000
DTEND;TZID=Europe/Brussels:20230418T160000
DTSTAMP:20260728T025633
CREATED:20230124T170639Z
LAST-MODIFIED:20230406T134218Z
UID:5708-1681830000-1681833600@www.europabio.org
SUMMARY:Development of Orphan Biologics: Challenges and Opportunities
DESCRIPTION:Webinar sponsored by Catalent \n\n\n\n\n\n\n\n\n\nThe development of therapies for rare diseases comes with distinct challenges\, including patient recruitment\, setting meaningful clinical endpoints\, manufacturing and supply and finding the regulatory and market pathway to ensure patients can access therapy. \n\n\n\nFor biologic products (growth factors\, monoclonal antibodies\, other complex proteins)\, development and production costs tend to be higher due to the complexity of the drug substance. To manage costs\, the clinical development and manufacturing and Chemistry\, Manufacturing and Controls (CMC) teams need to be aligned to ensure drug product is delivered on time to meet clinical trial needs. \n\n\n\nThese challenges sit within a wider regulatory and legislative framework for orphan medicinal products (OMPs) that defines whether companies can successfully develop a novel product to market and thus the decisions made for selecting therapeutics and target diseases early in development. \n\n\n\nDuring this webinar\, speakers cover aspects of clinical trial design for orphan biologics products\, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.Key Learning Objectives \n\n\n\n\nConsiderations in identifying meaningful clinical endpoints for orphan diseases\n\n\n\nOrphan clinical trial design considerations and strategies to ensure sufficient patient recruitment\n\n\n\nManufacturing and clinical supply strategies to ensure supply of clinical trial materials while collecting data needed to support NDA submission\n\n\n\nRegulatory and legislative frameworks that guide decision making for innovation in rare diseases\n\n\n\n\nAgenda \n\n\n\n15:00: Welcome and introduction – Claire Skentelbery\, Director General EuropaBio \n\n\n\n15:05: Current Development of Orphan Drugs in Europe – Matthias Schoenermark\, Professor\, President and CEO\, SKC Beratungsgesellschaft mbH \n\n\n\nProf. Schönermark opens the session with an overview of the current status of orphan drug development in the EU. He discusses the main challenges for market entry of new orphan drugs into the EU market and highlights key recommendations to drug developers to address these challenges. \n\n\n\n15:20: Orphan Biologics and CGT Development – CMC and Clinical Trial Supply Considerations – Wai Lam Ling\, Ph.D.\, Vice President\, Science and Technology\,  Catalent \n\n\n\nDr. Ling discusses the difference in CMC challenges encountered during an orphan biologics vs CGT programme\, with a focus on product quality as the most significant hurdle to approval. She addresses manufacturing approaches to ensure regulatory compliance and factors behind a successful product\, particularly robust\, reproducible and cost-effective pathways. Finally\, supply chain liabilities are discussed\, with risks to production of biologics and their clinical supply. \n\n\n\n15:45: Successful Strategies and Business Model For Companies Bringing Their Orphan Drug To Market –Thomas Bols\, Head of Government Affairs and Patient Advocacy\, EMEA & APAC\, PTC Therapeutics \n\n\n\nThomas Bols addresses the spectrum of opportunities and barriers for innovation within orphan drug development\, particularly across different regulatory territories\, and the critical role of smaller companies in addressing unmet medical needs. He focuses on the legislative and regulatory pathways that exist in Europe for orphan drugs and the potential impact of the upcoming pharmaceutical and OMP legislation revisions for company innovation and patient benefits. \n\n\n\n16:00: Close \n\n\n\n\nRegister here
URL:https://www.europabio.org/event/development-of-orphan-biologics-challenges-and-opportunities/
LOCATION:Catalent
CATEGORIES:EuropaBio,External,Healthcare Biotech
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DTSTART;TZID=Europe/Brussels:20230228T110000
DTEND;TZID=Europe/Brussels:20230228T121500
DTSTAMP:20260728T025633
CREATED:20230117T135652Z
LAST-MODIFIED:20230118T100150Z
UID:5661-1677582000-1677586500@www.europabio.org
SUMMARY:SME BioForum: Rare diseases
DESCRIPTION:Rare Disease Day takes place on February 28th across the globe to raise awareness among policymakers and the public about rare diseases and their impact on patient’s lives and their families. \n\n\n\nBuilding on the latest SME BioForum on Advanced Therapy Medicinal Products (ATMPs)\, EuropaBio – the European Association for Bioindustries will mark this day by hosting an online\, invite-only SME BioForum solely dedicated to rare diseases. The event will take place from 11h00 to 12h15 CET. \n\n\n\nThe meeting is entirely SME driven. SME participants will connect with their peers\, share their experiences and discuss the current regulatory and incentives framework ahead of the revision of the pharmaceutical legislation and the legislation on orphan and pediatric medicines. \n\n\n\nIf you have any queries or want further details\, please get in touch with José Peres at j.peres@europabio.org. \n\n\n\n\nSME BioForum 2022 Report: Advanced Therapy Medicinal Products
URL:https://www.europabio.org/event/sme-bioforum-rare-diseases/
CATEGORIES:Healthcare Biotech,SME Platform
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