Fabian Davila

If you’re attending #CPHIMilan on October 9, join us for a deep dive into Oncology’s latest innovations. IQVIA expert Aurelio Arias will present ‘Exploring Emerging Innovations in Oncology”, where we will explore growth areas within Oncology, evaluate patient outcomes, discuss successful medicine launches, and delve into future clinical trials, manufacturing advancements, and off-patent opportunities. Don’t miss it! https://bit.ly/3Z85X3a #GlobalMarketInsights #OncologyInnovation #HealthcareAdvancements

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Delving into the ethical landscape of health technology assessment: navigating the principles of beneficence, justice, autonomy, transparency, and accountability to ensure innovations serve patient welfare and societal needs. Join the discussion with BioXplore, experts in HTA and implementation in LATAM. Contact us to enter this market or enhance your performance in market access, Listen to the podcast here: https://lnkd.in/etzvYJWj Contact us at bioxplore.org to learn more #HealthTechEthics #EthicalConsiderations #HealthcareInnovation #TechnologyAssessment #PatientCare #EthicalTech #HealthcareEthics #InnovativeHealthcare #HealthTechAssessment #Beneficence #JusticeInHealthcare #PatientAutonomy #TransparencyInTech #AccountabilityInHealthcare #EthicalDecisionMaking #HealthcareValues #PatientWelfare #HTAImplementation #MarketAccess

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🎤 Live from Biosimilars LatAm - Europe 2024! 🌍✨ Cleber shared impactful insights at the session "Market Access Challenges and Opportunities for Biosimilars in Latin America." 🌐💊 📣 "We cannot forget the most important link in the healthcare chain: patients. This is why we think that PDPs aren't just a win-win partnership, but rather a win-win-win, as it benefits international manufacturers, the local public and private sectors, and the patients." - Cleber Sato, Sandoz His perspective highlights the multifaceted benefits of #PDPs, emphasizing patient-centric healthcare solutions. #Biosimilars #Healthcare #PatientCare #LatinAmerica #BiosimilarsLatAm #Europe2024 #HealthInnovation

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Recently, Pedro Reyes Cardona, our Project Manager - LATAM, presented a talk on key tools to accelerate clinical research in the event ACROM 360. It happened between a series of encounters aimed to debate important themes regarding CROs, such as pharmacovigilance, good research practices, regional regulations, and optimization of studies - theme of Pedro’s presentation. The core of his lecture was the “Lean” and “Six Sigma” techniques, crucial methodologies for enhancing efficiency and precision in clinical trials. Swipe and explore these and other practical ways to optimize innovative studies! Alianza de CROs de Mexico (ACROM) #projectmanagement #optimization #projectmanager

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What will it take to shape the future of patient care? Our May #BridgingtheGap webinar with @Dr. Miguel Forte was a deep dive into improving access to advanced therapies, and covered issues such as: 🌐 Holistic Access: Beyond finances – knowledge, infrastructure, regulation. 🧬 Tech Breakthroughs: Automation and iPSCs making therapies accessible. 🌍 Global Strategies: Unique approaches from Brazil to India. 📣 Patient Advocacy: Stories driving policy and development. 📑 Regulatory Adaptation: Evolving frameworks for timely access. Read the blog: https://hubs.ly/Q02MzkMQ0 #CancerResearch #Oncology #LifeSciences #CGT

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Head and neck cancer trials present unique imaging challenges that can impact image interpretation and confound trial results. Join Dr. Juan Gutierrez in our Medical and Scientific Affairs Group for a webinar enlightening on pitfalls that can impact your trial.

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Are coming to ICPP2024 in Pamplona, Spain? Join us at our Symposium: "The roles of heme & diseases related heme deficiency"

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Spain’s long-awaited draft Royal Decree on HTA has finally been published. It sets out the broad framework for the future of HTA in the country, rather than providing detailed methodological directions.   STRUCTURE A Governance Council of 21 members, including six representatives of the autonomous communities, will oversee the HTA system.   Two Offices for the Evaluation of the Efficiency of Health Technologies—one for medicines, the other for other technologies—will conduct evaluations.   The Health Technologies Positioning Group will carry out a final assessment based on the evaluation reports prepared by the Offices as well as other relevant information. Where the Positioning Group cannot reach a consensus, decisions will be made by simple majority.   SCOPE The HTA process will be aligned with EUnetHTA’s nine domains and split into clinical and non-clinical parts.   Clinical evaluation reports will contain conclusions regarding overall added clinical value—using the methodology proposed by the Office and approved by the Governance Council—but will not make recommendations for subsequent decision making.   Economic evaluations will include an assessment of cost-effectiveness and budget impact. Value assessment will take account of relative effectiveness, societal value and impact on HRQoL.   Evaluations of clinical and non-clinical aspects will not contain judgements regarding the positioning within the healthcare system, pricing, reimbursement or coverage by the common portfolio of services.   If an evaluation identifies evidence gaps, measures may be proposed to solve them; these should be pragmatic, proportionate and viable.   TIMELINES Ninety calendar days will be allowed for completion of clinical evaluation reports. If an EU joint clinical assessment report is available, this timeline will be reduced to 20 calendar days. Similarly, 90 calendar days will be allowed for the non-clinical evaluation. These deadlines will be extended by 30 calendar days if it is necessary to collect additional information: manufacturers will have 10 calendar days to provide such information.   OTHER NOTABLE DETAILS Manufactures will have opportunities for early dialogue with the Office for the Evaluation of the Efficiency of Medicines.   Health technology developers will be required to provide reliable data on the costs of R&D and production, as well as the sources (public or private) of funding for these activities.   Companies will receive draft evaluation reports and have opportunity to correct technical/factual inaccuracies and indicate content they consider to be confidential but will not be permitted to make observations on the results of evaluations.   The use of real-world data will be encouraged, and the Ministry of Health will maintain information systems that allow the evaluation and monitoring of results.   A public consultation on the draft Royal Decree runs until 20th September 2024 (tinyurl.com/mrp33xa9).   #Spain #HTA #reform #royaldecree

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Hear firsthand from a dedicated healthcare professional in Colombia about the transformative impact of Nipro’s CLFine on patient care. Watch the review to see how innovation is enhancing lives and improving outcomes. Discover more on CLFine: https://lnkd.in/dc4arSdp Watch Now! 📺 #wearenipro #TransformingLives #HealthcareInnovation #PatientCare #infectionprevention #MedicalReview

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Explore insights on conducting clinical trials in Latin America with bioaccess®, the Medtech LATAM CRO experts. Our blog offers critical perspectives on optimizing medical device development amidst diverse regulatory landscapes. Unlock the potential of this region by visiting: https://bit.ly/3YfsCbC 🌎 #Medtech #ClinicalTrials #LatinAmerica #MedicalDevices

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