Pedro Yoshikawa’s Post

The CIOMS Working Group XIII have just released their Real-world data and real-world evidence in regulatory decision making report. The intended audience includes medicinal product regulators, healthcare payers, health care and medicinal products industries, researchers, bioethicists, patients and health care professionals. This report was developed to inform discussions about the use of RWD and RWE for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). https://lnkd.in/dSXPHy-T

The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) for medicinal products has just been published! This is a major milestone in the journey to the new era of European Health Technology Assessment (EU HTA). What does this mean for you as you prepare a product launch for 2025? Explore the details of the Implementing Act on JCA to learn what changes have occurred, what issues remain unaddressed, and how to prepare for the upcoming final implementation of EU #HTA in 2025. https://bit.ly/3xXEnKs

🚀 Boosting health with FDA’s diversity guidance Achieving diversity in clinical research has been a challenge and many trials are falling short of their diversity goals daily. The FDA - La Administración de Alimentos y Medicamentos has offered a light at the end of the tunnel by pushing concrete plans to further diversity in clinical trials. Why is this crucial? Testing drugs across diverse populations helps ensure safety and efficacy in various of patients. Lokavant CEO Rohit Nambisan shares his insights with PharmaVoice alongside Julie Ozier from Advarra and Pamela Tenaerts, MD, MBA from Medable, Inc on how the FDA’s new guidance can address the underrepresentation of minority patient populations in clinical research and its impact in the health industry. 📰 Read the full article here. https://lnkd.in/dxESeiH8 #clinicalresearch #clinicaltrials

The draft Implementing Act (IA) on Joint Clinical Assessment (JCA) for medicinal products is a major milestone in the journey to the new era of European Health Technology Assessment (EU HTA). What does this mean for you as you prepare a product launch for 2025? Explore the details of the Implementing Act on JCA to learn what changes have occurred, what issues remain unaddressed, and how to prepare for the upcoming final implementation of EU HTA in 2025. https://bit.ly/4dMBICs

📣 The consensus report of the CIOMS (Council for International Organizations Of Medical Sciences) Working Group XIII on Real-world data and real-world evidence in regulatory decision making was published! 🎯 This report was developed to inform discussions about the use of RWD and RWE for regulatory and health care decision making, including decisions to make a product available for use (authorisation), to cover the costs of its use (reimbursement), and to use a product for a particular patient (clinical use). 👇 If you are working in the Real World Evidence field, you should have a look to this interesting document: https://lnkd.in/dxmZCxhE. #RealWorldData #RealWorldEvidence #RegulatoryPurpose #BeyondClinicalTrials #TogetherWithClinicalTrials

📢 𝗧𝗵𝗲 𝗳𝗶𝗿𝘀𝘁 𝗱𝗿𝗮𝗳𝘁 𝗼𝗳 𝘁𝗵𝗲 𝗻𝗲𝘄 𝗥𝗼𝘆𝗮𝗹 𝗗𝗲𝗰𝗿𝗲𝗲 (𝗥𝗗) 𝗼𝗳 𝗛𝗲𝗮𝗹𝘁𝗵 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 (𝗛𝗧𝗔) 𝗶𝗻 𝗦𝗽𝗮𝗶𝗻 𝗵𝗮𝘀 𝗯𝗲𝗲𝗻 𝗺𝗮𝗱𝗲 𝗮𝘃𝗮𝗶𝗹𝗮𝗯𝗹𝗲 𝗮𝗻𝗱 𝗼𝘂𝘁𝗹𝗶𝗻𝗲𝘀 𝘁𝗵𝗲 𝗳𝗼𝗹𝗹𝗼𝘄𝗶𝗻𝗴 𝗸𝗲𝘆 𝗰𝗵𝗮𝗻𝗴𝗲𝘀 𝗳𝗼𝗿 𝗱𝗿𝘂𝗴 𝗲𝘃𝗮𝗹𝘂𝗮𝘁𝗶𝗼𝗻𝘀: • The creation of a new Governance Council to oversee the new Office for the evaluation of the efficiency of health technologies and the Positioning Groups of health technologies, with the aim to separate the evaluation process from decision-making and ensure national transposition of EU directives for drug evaluations • The reinforcement of non-clinical assessments, with an increasing role of economic evaluations which will now become mandatory, and requests for disclosure of production and R&D costs • A reduction in planned assessment timelines with the aim to provide faster drug access to patients • Increasing transparency in the drug evaluation process, given the assessments will be made publicly available • Increasing engagement with manufacturers and patient and scientific societies, through participation in committees and external consultation processes throughout the evaluation process The draft RD is currently under final public consultation by relevant stakeholders and Ministry bodies and, as such, can still be subject to modifications. Once finalized and approved by all parties, the new RD is set to enter into force in January 2025. #RoyalDecreeLaw #Spain #HTA #Evaluation&DecisionMaking #MinistryofHealthSpain Become an Omakase follower for further updates

Today, #generics play a crucial role in our healthcare system, providing unprecedented savings worldwide. But is there more to generics than just cost-cutting?   Join @Medicines for Europe for an insightful webinar on April 10 to discuss the new study #BeneathTheSurface and discover the long-term benefits of #generics for the sustainability and availability of essential medicines.   Arnaud Mahéas, Public Affairs Head Europe at Sandoz and Chair of the Generic Market Access Committee at Medicines for Europe, will be sharing his thoughts on the topic. Register now!   #GenericMedicines #AccessForAll

💊Dutch #competition and #healthcare authorities collaborate on socially acceptable medicine prices - while fostering innovation💰 "The costs of new, expensive medicines are rising faster than overall medical-specialist care expenses, posing a significant challenge to the sustainability of our healthcare system", says ACM healthcare director Bart Broers. Last year, Zorginstituut Nederland, The Netherlands Authority for Consumers and Markets and the Nederlandse Zorgautoriteit launched the "Socially Acceptable Medicine Expenditure and prices" programme (in Dutch: “Maatschappelijk Aanvaardbare Uitgaven en prijzen van Geneesmiddelen”). This programme aims to advise the health minister on a framework for determining acceptible medicine expenditure, with recommendations for its application. Key points: 👉 Establishing a Framework: Defining socially acceptable expenditures on medicines, balancing costs, benefits, and innovation. 👉Regulatory Focus: Shifting from accessibility to pricing, ensuring cost-effectiveness and societal impact are being considered. 👉Market Behavior Analysis: Investigating pharmaceutical companies’ pricing strategies and ethical considerations. 👉Public and Expert Consultation: Engaging with experts and the public to understand acceptable spending on medicines. 👉International cooperation: Exploring collaboration with other countries to enhance regulatory impact and influence on pharmaceutical pricing. Broers: “It’s about finding a balance between costs, benefits, and innovation. Prices must be high enough to stimulate innovation and low enough to be acceptable.” The collective's findings can be expected in the second half of 2025. 🌍💊 #Healthcare #Pharmaceuticals #Innovation #Sustainability #PublicHealth #Collaboration #Regulation #CostManagement Source: Zorginstituut Magazine oktober 2024 (link in comments)

CIOMS is pleased to announce the publication of the consensus report on Real-World Data and Real-World Evidence in Regulatory Decision Making, addressing the use of RWE for regulatory and healthcare decisions. #realworlddata #RWE #RWD #healthcare #regulatoryscience #CIOMS #medicalaffairs #medicinesdevelopment #GMDPacademy

𝗢𝘂𝗿 𝗰𝗼𝘂𝗻𝘁𝗱𝗼𝘄𝗻 𝘁𝗼 𝘁𝗵𝗲 𝗘𝘂𝗿𝗼𝗽𝗲𝗮𝗻 𝗛𝗧𝗔 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗶𝗼𝗻! 📝 𝗪𝗵𝗮𝘁 𝗶𝘀 𝘁𝗵𝗲 𝗝𝗼𝗶𝗻𝘁 𝗖𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 (𝗝𝗖𝗔)? The JCA is at the heart of the HTA Regulation. This process focuses solely on assessing the 𝗿𝗲𝗹𝗮𝘁𝗶𝘃𝗲 𝗰𝗹𝗶𝗻𝗶𝗰𝗮𝗹 𝘃𝗮𝗹𝘂𝗲 of a new health technology 𝗰𝗼𝗺𝗽𝗮𝗿𝗲𝗱 𝘁𝗼 𝗼𝗻𝗲 𝗼𝗿 𝗺𝗼𝗿𝗲 𝗮𝗽𝗽𝗿𝗼𝗽𝗿𝗶𝗮𝘁𝗲 𝗰𝗼𝗺𝗽𝗮𝗿𝗮𝘁𝗼𝗿𝘀 𝗼𝗿 𝘁𝗵𝗲 𝘀𝘁𝗮𝗻𝗱𝗮𝗿𝗱 𝗼𝗳 𝗰𝗮𝗿𝗲, without evaluating its  𝗽𝗿𝗶𝗰𝗲 𝗼𝗿 𝗰𝗼𝘀𝘁-𝗲𝗳𝗳𝗲𝗰𝘁𝗶𝘃𝗲𝗻𝗲𝘀𝘀. It is defined by the 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝗦𝗰𝗼𝗽𝗲 𝗽𝗿𝗼𝗰𝗲𝘀𝘀, which involves identifying the parameters for the JCA in terms of 𝗣𝗼𝗽𝘂𝗹𝗮𝘁𝗶𝗼𝗻, 𝗜𝗻𝘁𝗲𝗿𝘃𝗲𝗻𝘁𝗶𝗼𝗻, 𝗖𝗼𝗺𝗽𝗮𝗿𝗮𝘁𝗼𝗿𝘀, 𝗮𝗻𝗱 𝗢𝘂𝘁𝗰𝗼𝗺𝗲𝘀 (𝗣𝗜𝗖𝗢). The process is divided into three phases: - 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝘀𝗰𝗼𝗽𝗲 𝗽𝗿𝗼𝗽𝗼𝘀𝗮𝗹: The JCA subgroup, after receiving input from clinical experts and patients, and based on documents provided by the HTD to EMA, shares the assessment scope proposal with Member States through a PICO survey. - 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝘀𝗰𝗼𝗽𝗲 𝗰𝗼𝗻𝘀𝗼𝗹𝗶𝗱𝗮𝘁𝗶𝗼𝗻: all PICOs are collected to reach the "Least Common PICO." This involves eliminating duplicates to achieve the smallest number of PICO while ensuring all Member States' requirements are included. - 𝗔𝘀𝘀𝗲𝘀𝘀𝗺𝗲𝗻𝘁 𝘀𝗰𝗼𝗽𝗲 𝗳𝗶𝗻𝗮𝗹𝗶𝘀𝗮𝘁𝗶𝗼𝗻: In this phase finalizes the process and shares the PICOs with the HTD. 🧩 𝗪𝗵𝗮𝘁 𝗶𝘀 𝗣𝗜𝗖𝗢? The PICO model is a fundamental tool for formulating clinical or research questions in a structured way, making it easier to identify relevant evidence. Click here to read the 𝗣𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗮𝗹 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲 𝗳𝗼𝗿 𝗝𝗖𝗔 𝗺𝗲𝗱𝗶𝗰𝗶𝗻𝗮𝗹 𝗽𝗿𝗼𝗱𝘂𝗰𝘁𝘀 👉 https://lnkd.in/dnB55sDt If you missed the first post, you can find it here https://lnkd.in/ddrdcpRQ. Until January 12, we will be sharing key concepts to guide you towards the implementation of the new regulation. #HTAR