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From March 12 to 13, 2024, the World Evidence, Pricing and Access Congress will take place in Amsterdam. Meet the colleagues of the SKC and numerus team at the JCA90 booth (no. 1️⃣4️⃣) and discuss with us AMNOG pricing and European HTA in the context of the upcoming JCA. The world's leading congress on evidence, pricing and access will bring together over 1,500 industry representatives in Amsterdam. We look forward to being there! Discuss with our experts key topics such as 👉Evidence - How can I analyze and realistically assess the European PICO schemes at an early stage? 👉Pricing - How do I define an adequate launch price and what strategy do I need to achieve an appropriate reimbursement amount? 👉Access - How can I create a JCA dossier efficiently and effectively despite ongoing uncertainties? 👉Orphans & ATMPs - Which special considerations do I need to take into account for the European and German market access of orphan drugs and ATMPs? Further information can be found at https://lnkd.in/ejRDPds8 and https://lnkd.in/eHPWTZMe.

Join us at the EUCROF24 conference, we are looking forward to share our expertise in the development of decentralized clinical trials (DCT) and real-world data studies #clinicalresearch #clinicaltrials #clinicaloperations #dct #realworlddata

With less than a week to go until EUCROF24, hear from Dagmar Chase, Co-Chair of the EUCROF24 Programme Committee...... In our latest video, Dagmar highlights the Clinical Trials Regulation (CTR)/Clinical Trials Information System (CTIS) breakout stream that will be taking place at the Conference, and how the transition period for clinical trials is a hot topic across the industry. The CTR/CTIS breakout stream will take place alongside three others, which cover the topics: Decentralised Clinical Trials, Artificial Intelligence and Insights. Find out more about EUCROF24 and view the programme here: https://lnkd.in/eMP3DzC6 Dr. Martine Dehlinger-Kremer, Benedikt Van Nieuwenhove, Dagmar Chase, Yvonne Rollinger, Darina Hrdlickova, Simon Lee, Martin Krauss, Christophe Golenvaux, Donato Bonifazi, Martin O'Kane EUCROF Member Associations include: ACRO CZ, AECIC, AFCROs, AICRO - Associazione Italiana CRO, ASCRO, BeCRO, the Belgian Association of CROs, Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA), CCRA, HACRO - Hellenic Association of CROs, Lithuanian GCP&RA Association, SAKDER, SACROP, ACCSCR, ACRON #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #eucrof24 EUCROF Headquarters

👏 A successful meeting of the Clinical Trials Coordination Group this week!   🔬 There were a lot of important topics on the agenda, including: the transition of all ongoing clinical trials in line with the new European regulation (Clinical Trials Regulation) by the end of January 2025, and an update on ongoing projects around the acceleration of clinical trials in emergency situations, such as the corona crisis.    👩⚕️ There was also discussion about the possibility for advice just before submission of a clinical trial and how these could be linked to existing advisory procedures.   🇧🇪 Did you know that Belgium is one of the pioneers of clinical research within Europe? Thanks to this intensive cooperation, innovation and research are further stimulated and we continue to make Europe attractive for setting up clinical trials. #EU2024BE #clinicaltrials

Somebody asked us “What are the different breakout streams for EUCROF24?”…… The EUCROF 2024 Conference programme will be a blend of presentations, expert panels and discussion groups reflecting the status of Clinical Research, whilst at the same time including views on current challenges, hot topics and the future direction. EUCROF24 will also see the introduction of 4 new breakout streams running across the 2 days, these are: > CTR/CTIS > Decentralised Clinical Trials > Artificial Intelligence > Insights Taking place in Prague from the 19-20 February, discover the sessions of each breakout stream here: https://lnkd.in/eMP3DzC6 Dr. Martine Dehlinger-Kremer, Benedikt Van Nieuwenhove, Dagmar Chase, Yvonne Rollinger, Darina Hrdlickova, Simon Lee, Martin Krauss, Christophe Golenvaux, Donato Bonifazi, Martin O'Kane EUCROF Member Associations include: ACRO CZ, AECIC, AFCROs, AICRO - Associazione Italiana CRO, ASCRO, BeCRO, the Belgian Association of CROs, Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA), CCRA, HACRO - Hellenic Association of CROs, Lithuanian GCP&RA Association, SAKDER, SACROP, ACCSCR, ACRON #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #eucrof24 EUCROF Headquarters

Heading to the #DIA Europe 2024 in Brussels? 👀 Meet the #JNPMEDI team of experts; Jayden (Joon Hyuk) Lim and Bijesh Manikoth! We can't wait to engage with our valued customers, partners, and industry peers at this fantastic event! Let's discuss how our #MavenClinicalCloud solutions drive innovative clinical trials and achieve your study goals together! See you there! 👋 #DIA #DIAEurope2024 #JNPMEDI #MAVEN #MavenClinicalCloud #DecentralizedClinicalTrials #DigitalClinicalTrials #DCT #ClinicalTrials

Why should you be present at EUCROF24……Dr. Martine Dehlinger-Kremer tells us why…… In our latest video, hear from EUCROF President Martine on why you should be attending the EUCROF24 Conference in Prague, from the 19-20 February. Martine also takes us through the different breakout streams occurring at EUCROF24, which cover 4 key areas across the industry: > Clinical Trials Regulation/Clinical Trials Information System > Decentralised Clinical Trials > Artificial Intelligence > Insights Discover the sessions of each breakout stream in the EUCROF24 programme here: https://lnkd.in/eMP3DzC6 Dr. Martine Dehlinger-Kremer, Benedikt Van Nieuwenhove, Dagmar Chase, Yvonne Rollinger, Darina Hrdlickova, Simon Lee, Martin Krauss, Christophe Golenvaux, Donato Bonifazi, Martin O'Kane EUCROF Member Associations include: ACRO CZ, AECIC, AFCROs, AICRO - Associazione Italiana CRO, ASCRO, BeCRO, the Belgian Association of CROs, Bundesverband Medizinischer Auftragsinstitute e.V. (BVMA), CCRA, HACRO - Hellenic Association of CROs, Lithuanian GCP&RA Association, SAKDER, SACROP, ACCSCR, ACRON #clinicalresearch #clinicaltrials #clinicaloperations #gcp #bigpharma #dct #eucrof24 EUCROF Headquarters

With less than a week to go until the IMAS Conference 2023 kicks off in Budapest, final preparations are under way. Will you be attending? Our very own Christian Hill and Brian Gavin, along with other industry leaders, are hosting a workshop on ‘Global HTA collaboration; what can we learn and expect from these initiatives?’ on 2 October 2023, as part of the IMAS Conference.   The session is run as a pre-conference workshop featuring interactive sessions, as well as insights from an expert panel: * Meindert Boysen PharmD MSc as Head of NICE International who will share his insights from a UK and international HTA perspective * Darren Walsh as Head of Orchard Therapeutics in the UK and Ireland who will contribute based on his direct experience of EU HTA collaboration * Alexander Natz as Secretary General of EUCOPE, with a focus on the German legal and EU trade group perspective * Christian and Brian with insights from supporting companies with EU HTA preparedness and US market entry to Europe   This workshop takes place on 2 October 2023 at the IMAS (International Market Access Society) Conference in Budapest. Find out more about the conference in this PDF.   We hope to see you there.   #HTA #EUHTA #IMAS #MarketAccess

👏 Today, at the IMI Trials@Home Annual Meeting, Ken Tait, Erik Werson and Kostas Tagkalos, members of the Patient Expert Panel (PEP) coordinated by IDF Europe, are leading a session about the translation of #research in layman language. 🔎 Trials@Home is a project aiming to reshape clinical trial design, conduct and operations, by developing and piloting standards, recommendations and tools for the definition and operationalization of decentralized clinical trials in Europe. 💡 The active participation of the PEP in the project is essential to ensure that the views, perspectives and insights of people living with #diabetes are represented across all research stages. ➡ Learn more about the project: https://trialsathome.com/ Mia Bajramagic, Sabine Dupont

ALL THINGS ATMP ✅ Recently, ATMP Sweden hosted 12 speakers over 3 days, in a well-executed online conference; the ATMP World Tour 2024 🌍🌎🌏 It covered a wide range of ATMP-related topics, presented by international experts. The recordings from the event are available until the end of this month and you should go check it out, if any of the points below resonate with you: ⭐ It is important to be an ATMP advocate and make a positive impact ⭐ Regulatory systems should be evidence-based and keep up with the speed of innovation ⭐ Access to visible role models in CGT is needed ⭐ Accelerated regulatory approvals are necessary, especially in the rare disease space ⭐ Commercialization of ATMPs is relevant; and keeping ATMPs non-commercial is also important It is evident that the field of ATMP is complex and requires collaboration between a multitude of disciplines to succeed and bring the beneficial therapeutic effects all the way to the patients. Let's keep up the stamina together🚀 #ATMP #cgct #recommendation #collaboration