Marta Rodríguez Vélez’s Post

In the second session of the GetReal Institute Conference 2024, an expert panel, moderated by Álmath Spooner (AbbVie), explored the integration of #RWE in #regulatory decision-making. Panelists included Patrice Verpillat (European Medicines Agency), Donna Rivera (FDA), Alison Cave (Medicines and Healthcare products Regulatory Agency) and Katrien Oude Rengerink (College ter Beoordeling van Geneesmiddelen–Medicines Evaluation Board [CBG-MEB]). Read at The Evidence Base® #rwd #realworldevidence #realworlddata #regulation #regulatoryaffairs #healthdata #healthpolicy

🚀 Essential Resource Alert: Biosimilars in the EU🚀 I would to share a highly informative presentation from the European Medicines Agency (EMA) and the European Commission on Biosimilars in the EU. This guide is a goldmine of insights for healthcare professionals and anyone interested in the future of medicine. Here’s what you’ll find: 1. Comprehensive Overview:   Understand what biosimilars are and how they differ from traditional generics. The presentation explains why biosimilars are crucial in today’s healthcare landscape. 2. Regulatory Excellence:   Discover the robust regulatory framework that the EU has established to ensure that biosimilars meet the highest standards of safety and efficacy. 3. Clinical Safety and Efficacy:   Learn about the stringent processes involved in the approval of biosimilars, ensuring they are as safe and effective as the original biological medicines. 4. Impact on Healthcare:     See how biosimilars are making healthcare more accessible and affordable across Europe, benefiting patients and healthcare systems alike. 5. Expert-Backed Information:   This presentation is prepared by leading experts and offers trustworthy, detailed insights that are essential for any healthcare professional. Whether you're directly involved in healthcare or simply passionate about advancements in medicine, this resource is a must-read. 🌟 Let’s embrace the future of healthcare together! P.S. If you find this information valuable, please share ♻️ it with your network to help spread the knowledge. #Biosimilars #HealthcareInnovation #EURegulations #PatientCare #MedicalAdvancements #EU #sfda #kaust #gcc #middleast #copied #regulatoryintelligence #regulatoryexcellence #regulatory

🗺 Missed Day 1 of World Orphan Drug Congress? Check out our Remap Consulting summary below 👇 #WODC2024 #EUHTA #PatientAccess #Healthcare #MarketAccess #Pharma #EUHTA #jointclinicalassessment

New 2024 Italian AIFA Commission CSE Up and Running – Insights from First Meetings   The new AIFA Scientific and Economic Committee (CSE) has integrated the roles of the CTS and CPR to streamline health technology assessments and drug evaluations, focusing on cost-efficiency and improved processes. The CSE meetings take place monthly, with additional meetings scheduled as needed. For example, an extraordinary meeting on May 6th and 7th was organized to reduce the initial backlog of 130 HTA and pricing procedures. The CSE comprises 8 appointed members and 2 ex officio members.   Notable CSE Missions for medicines: - Defining the Supply Channel: Specifies how the product is dispensed and prescribed, and whether it is restricted to certain specialist physicians or settings. - Establishing the Place in Therapy: Evaluates the added therapeutic value of a medicine for NHS reimbursement eligibility. - Classifying Innovative Drugs: Aligns with Article 1, paragraph 402 of Law No. 232 of December 11, 2016, to classify innovative drugs. - Allocating Innovativeness Requirements: Determines access to reimbursability with resources from the innovation fund. - Price negotiations   For more details on the CSE, the key changes, objectives, responsibilities, confirmed members of the CSE, or other related information, visit our website Justin Stindt Consultants (https://jstindt.com/aifa/). Follow our company LinkedIn page Justin Stindt Consultants for latest updates   #AIFA #CSE #JSCSupport #MarketAccess #Italy

Dive into our latest article by Dr. Christian K Schneider on the evolving landscape of #biosimilars. As these life-saving medicines come of age, discover the key opportunities and challenges they present. Key Takeaways: 🔑 The biosimilars industry is projected to reach $74 billion by 2030, significantly increasing patient access. 🔑 The FDA and EMA's regulatory frameworks are critical but require ongoing adaptation and collaboration. 🔑 Educational initiatives are essential to combat misinformation and foster confidence among stakeholders. Gain insights from industry leaders like Leah Christl, Ph.D., Martin Schiestl, Ph.D., and Dr. Elena Wolff-Holz, MD, on navigating the complexities of biosimilar development and regulation. 📖 Read more: https://lnkd.in/d976FaSC #HealthcareInnovation #RegulatoryAffairs #PharmaLex

🌍 Day 1 at the World Orphan Drug Congress 2024 kicked off with a strong focus on the EU Joint Clinical Assessment (JCA), one of the most significant healthcare policy shifts in a decade. 𝐊𝐞𝐲 𝐝𝐢𝐬𝐜𝐮𝐬𝐬𝐢𝐨𝐧 𝐩𝐨𝐢𝐧𝐭𝐬: 🔑 The JCA, designed as a “one-stop shop” for regulatory and market access decisions, brings both opportunities and challenges. While it promises to streamline patient access, questions remain around pricing negotiations and national HTA processes 👥 Patient involvement was a hot topic, with many highlighting the gap between expectations and the current regulatory framework. Early scientific advice through Joint Scientific Consultations (JSCs) was flagged as critical for smooth navigation through the JCA process 👥 ⚖️ The path ahead is full of complexities, but with early planning and flexible approaches, companies can prepare for what’s to come Our 𝐃𝐚𝐲 𝟏 𝐒𝐮𝐦𝐦𝐚𝐫𝐲 𝐫𝐞𝐩𝐨𝐫𝐭 brings you all the highlights - https://lnkd.in/gMTER9DB #WODC2024 #EUHTA #PatientAccess #Healthcare #MarketAccess #Pharma #EUHTA #jointclinicalassessment

As we approach the EPSCO (EU Employment, Social Policy, Health and Consumer Affairs Council) meeting on 21st June, there's an array of crucial topics on the agenda that will shape the future of #healthcare and pharmaceutical #innovation in Europe. The meeting will include a progress report on the Pharmaceutical package, with a specific focus on the #incentives cluster. Additionally, the Council will seek to approve conclusions on the future of the #EuropeanHealthUnion, in which it sets out key areas of focus and encourage the incoming Commission to keep health as a priority. The Council will also seek to adopt a recommendation setting out new measures on vaccine-preventable cancers as part of #EUBeatingCancerPlan. Competitiveness, innovation, and patient access are at the core of the pharmaceutical industry, and we cannot afford to overlook the significance of maintaining a robust incentives system such as Regulatory Data Protection (#RDP) and Orphan Market Exclusivity (#OME). These incentives are pivotal for fostering pharmaceutical innovation, driving the development of life-saving treatments, and ensuring that patients have access to groundbreaking therapies that either prevent diseases, improve quality of life or cure. As industry leaders, it's imperative that we advocate for policies that support a thriving environment for innovation. The decisions made at this meeting will undoubtedly have a lasting impact on the future of healthcare in Europe, as well as patients and society at large. I look forward to the outcomes of the EPSCO meeting and hopefully the positive strides it will bring to the pharmaceutical landscape in Europe. On the other hand, I encourage the EU governments to keep an open dialogue with industry as partners and search for alternative solutions to solve #access, #availability and #affordability issues that we recognize and are willing to address. The real #value of innovation, after all, is only when patients get access to it.

Dive into our latest article by Dr. Christian K. Schneider on the evolving landscape of biosimilars. As these life-saving medicines come of age, discover the key opportunities and challenges they present. Key Takeaways: 🔑 The biosimilars industry is projected to reach $74 billion by 2030, significantly increasing patient access. 🔑 The FDA and EMA's regulatory frameworks are critical but require ongoing adaptation and collaboration. 🔑 Educational initiatives are essential to combat misinformation and foster confidence among stakeholders. Gain insights from industry leaders like Leah Christl, Ph.D., Martin Schiestl, Ph.D., and Elena Wolff-Holz, MD, on navigating the complexities of biosimilar development and regulation. 📖 Read more: https://lnkd.in/d_mAHzSJ #Biosimilars #HealthcareInnovation #RegulatoryAffairs #PharmaLex

The recently published draft Royal Decree on #HTA in Spain outlines the establishment of a new “positioning group,” responsible for the preparation of key reports informing pricing and reimbursement decisions. These reports will replace the current therapeutic positioning reports developed by Spain’s drug regulator, AEMPS, and regional experts.  More specifically, clinical trial data and economic studies will be analysed by the new positioning group, that will ultimately make a recommendation on whether a drug should be reimbursed by the Interministerial Commission on Drug Prices (CIPM). Senior Health Ministry official César Hernández noted that the report preparation and pricing talks will be taking place in parallel, suggesting a more flexible system where price proposals from the manufacturer may be considered.  The regional perspective will be strongly represented in this new positioning group; 17 out of 27 members will represent each of the autonomous regions of Spain. This gives regional voices a more significant role compared to the CIPM, where regions currently only have a rotating presence in 3 out of the 11 votes. The impact that this is expected to have on P&R decisions remains unclear, however Hernández highlighted the value of considering regional perspectives in the HTA process.  While the Royal Decree on HTA has yet to be approved, Partners4Access will continue to monitor changes to the HTA landscape in Spain to understand how they may impact our clients’ current and future goals. For more information on how we can support your pricing, reimbursement, and market access (#PRMA) journey, please reach out. Written by Iro Malekou, Associate Consultant #P4AInsights #Spain #HTA #MarketAccess Sources:   1. https://lnkd.in/evKvHa9m

A decade of hard work with positive impact. Global health leaders came together to create the first international Consensus Framework for Ethical Collaboration between patients’ organizations, healthcare professionals, and the pharmaceutical industry in support of quality patient care. As of today, more than 12 economies around the world have adopted this initiative 🎯  For the Ethical Health Alliance, the Mexican Consensus Framework for Ethical Collaboration, it was an honor to receive the 2024 Lighthouse Award 🏆 within its two years of creation. This award recognizes an individual, organization, or economy that has served as a guide or model in strengthening the ethical business environment in one or more APEC economies. Let us continue strengthening the power of ethical collaboration. Because together, we are stronger! #integrity #health #GlobalEthicsDay #HealthPolicyWatch Alliance for Integrity Alianza Ética por la Salud IFPMAInternational Alliance of Patients' Organizations (IAPO) ICN-International Council of Nurses International Hospital Federation International Pharmaceutical Federation (FIP)World Medical Association