Giuseppe Biondi Zoccai’s Post

Hello Colleagues/ Collaborators, Exceptional British Islamic Medical Association (BIMA) Meeting, (2024). Various colleagues in Medicine doing some excellent works to prompt and highlight important topics across Medical Practices. Speakers and presentations also from those who have been working to integrate healthcare, conflict and war zones, informing of where healthcare disparities exist, across globally. Presentations also from British Medical Association (BMA) to identify different ways that professionals can alert aspects pertaining to healthcare professional centric support. #Healthcare #AttheHeartofHealthcare #evidencebase

1 day until the Meeting UK IRB/EC Expectations for Patient Review of Research Participant Information webinar. It's still not too late to sign up and listen to Behtash Bahador and Thomas Rhode Jørgensen address the crucial topic of meeting UK IRB/EC expectations for patient review of research participant information. Gain valuable insights and ensure your research aligns with the latest requirements. Secure your spot now for March 1st, 2024! #HealthResearch #EthicalStandards #ClinicalResearch #HealthcareCompliance #JamesLindCare

Register now for HFMA webinar Wednesday 24th April 12pm, a fireside chat between Dr David Tralaggan and Peter Joyce previous CFO from Alfred Health in Victoria. for a discussion on the importance of quality clinical documentation, especially Peter's view from his previous role at Alfred Health. Quality clinical documentation is indeed crucial for healthcare organizations, as it not only ensures accurate coding and billing but also supports patient care continuity, research, and regulatory compliance. Peter's experience at Alfred Health likely provides valuable insights into how effective clinical documentation practices can impact various aspects of healthcare operations, including financial management, risk mitigation, and overall patient outcomes. Fireside chats like these can offer practical strategies, case studies, and best practices that can be applied in healthcare settings to improve documentation quality and optimize revenue cycles. Register now: https://lnkd.in/gprUNYN6

🆕 🇪🇺 𝙃𝙚𝙖𝙡𝙩𝙝 𝙏𝙚𝙘𝙝𝙣𝙤𝙡𝙤𝙜𝙮 𝘼𝙨𝙨𝙚𝙨𝙨𝙢𝙚𝙣𝙩 (#𝙃𝙏𝘼): European Commission 𝗽𝘂𝗯𝗹𝗶𝘀𝗵𝗲𝗱 𝗻𝗲𝘄 𝗴𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗼𝗻 𝘃𝗮𝗹𝗶𝗱𝗶𝘁𝘆 𝗼𝗳 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘀𝘁𝘂𝗱𝗶𝗲𝘀 👨🔬 The European Commission has published a guidance document on the validity of clinical studies for joint clinical assessments under the EU Health Technology Assessment Regulation, adopted by the Member State Coordination Group (#MSCG). 🔗 Here is the link to the adopted guidance document: https://lnkd.in/eWdu2KFW 📰 "This guidance helps to define, classify, and assess the certainty of clinical study results in an objective, reproducible and transparent way. It covers the analysis of data from different types of single clinical studies.", European Commission states in their newsletter. "This guidance complements the guidance documents previously adopted by the Member State Coordination Group on outcomes for joint clinical assessments, on quantitative evidence synthesis for direct and indirect comparisons and on reporting requirements for multiplicity issues and subgroup, sensitivity and post hoc analyses in joint clinical assessments." The Member State Coordination Group on Health Technology Assessment (#MSCG #HTA) adopted the new guidance document at its 10th meeting on 19 September 2024. #HealthTechnologyAssessment #ClinicalStudies #Regulation #IVDR #MDR

Have you heard the news? The draft Implementing Act on Conflicts of Interest for the EU HTA Regulation can now be found online, as the public consultation started today. This Act comprises rules on COI in the joint work of the Member State Coordination Group on HTA and its subgroups. This includes COI of committee representatives and individual experts, e.g. patients and clinical experts. Feedback can be provided until the 26th of June, and Commission adoption is planned for Q2 2024 - of course we are on top of these developments! #EUHTA #JCA #COI #patientaccess Roisin Adams

Preparing for Joint Clinical Assessments (JCAs) can be challenging, but GIPAM is here to help! As specialists in Health Technology Assessment (HTA), we offer valuable support to streamline your preparation process and ensure compliance with all HTA requirements. JCA Guidelines - Everything you need to know - https://lnkd.in/eTU_WcJJ Here's how our expertise and services can assist you ⬇

What's Next for HTA in 2025? Insights from ISPOR Europe The ISPOR Europe conference in Barcelona highlighted key industry challenges, especially surrounding the upcoming changes to the HTA regulation and its impact on Joint Clinical Assessments (JCA) come January 2025. As the countdown begins, questions around readiness and adaptation remain top of mind for many stakeholders in the healthcare sector. Read our highlights here: https://buff.ly/4f00SOM #LumanityPerspectives #JCA #ISPOREurope

Vol. 14 No. 5 (2023): Special Edition: COVID-19 Clinical Management and Health-care Pathways

#EUHTA #PatientAccess #ImplementingAct ⚖ This morning, the second public consultation of the Implementing Act (#IA) of the #EUHTARegulation on conflicts of interest (#COI), has been released for public consultation. It is open until ⏰ 25th of June. This implementing act is composed of: 📓 The main text, which lays down the rules with regards to the management of conflicts of interest of the EU Member State HTA Coordination Group and its subgroups, as well as external experts (i.e. patients, clinical experts) who will be involved in the EU HTA joint work and 📝 two annexes which include: - Template of declaration of interest for participation in the joint work - Table on exclusions and limitations of the participation in the joint work https://lnkd.in/eWN6ji_K

On behalf of network organisation Long COVID Europe, which represents the interests of patients with #longcovid #mecfs, I presented the perspective of patients when it comes to developing clinical research projects. We urgently need to generate clinical evidence for the diagnosis and treatment of long covid. 4 years and we still have no treatment, no biomarker, no clear definition, no reliable data for a so far incurable disease affecting more than 34 million people across Europe. Our take-home message with regard to clinical research: 1. Focus on core biomedical mechanisms (immune and vascular dysregulation) to develop objective biomarkers for and treatments of specific cardinal symptoms such as exertion intolerance and PEM 2. Use, adapt & validate existing assessment tools, definitions, research infrastructures for related conditions such as ME/CFS 3. Facilitate off-label use of approved drugs in related indications (anti-coagulants, antivirals, immune-regulators, anti-inflammatory drugs) as long as there is no treatment and evidence from RCTs. 4. Facilitate targeted funding for research into post-infectious conditions & support and facilitate private-public partnerships to foster R&D 5. Involve patients and the public in research, healthcare, policies and funding decisions