VICORE HEALTH LTD’s Post

🔔 New Implementing Act on Information Exchange with EMA - Now Published! 🔔 📢 The European Commission has released the second implementing act, establishing key rules for cooperation with the European Medicines Agency (EMA) under the Health Technology Assessment (HTA) Regulation. 📍 Key highlights: This important step forward in the implementation of the HTA Regulation establishes the framework for sharing essential information. It covers areas such as planning and forecasting Joint Clinical Assessments (JCA) and Joint Scientific Consultations (JSC), as well as identifying the patients, clinical experts, and other stakeholders to participate in joint procedures. In addition, it provides direction on ensuring that any confidential information shared between the EMA, the HTA Secretariat, and the Member State Coordination Group is handled securely and protected at all times. 📅 Stay tuned for more updates on the evolving HTA landscape and how it may impact your regulatory strategy! With our expertise and extensive experience, we are well-equipped to support our clients. #HealthTechnology #JCA #JSC #EMA #Pharmaceuticals #Innovation #HTA #RegulatoryAffairs #ImplementingAct

🚨 New Paper Alert! 🌍💊 How does EU pharmaceutical regulation influence health systems and patients’ access to medicines globally, especially in developing economies?   My latest paper in the European Journal of Risk Regulation applies the theory and mechanisms of Europeanisation—conditionality, socialisation, externalisation, and mimicry—to explore how EU norms and rules shape foreign pharma regulation and markets worldwide.   Using the ongoing revision of the EU’s pharmaceutical legislation as a case study, I analyze how three innovative proposals (if adopted) may have ripple effects globally: ✔️ Environmental risk assessments for antimicrobials ✔️ Reporting public funding for medicines R&D ✔️ Revised clinical test data and market protection (including transferrable exclusivity vouchers).   📖 Read more about how the EU’s regulatory power travels and shapes global pharmaceutical systems: https://shorturl.at/DbRWW   Building on the work of Frank Schimmelfennig, Ulrich Sedelmeier, Tanja A. Börzel, Anu Bradford, Thomas Risse, Joanne Scott and others, my paper introduces a global lens to EU pharmaceutical regulation and illustrates pathways of potential EU influence drawing on evidence by Maria Cavaller Bellaubi, Martin Harvey Allchurch, Marco Cavaleri, Carlos Durán, Martin Cañás, Nusrat Shafiq, Anita Kotwani, Ellen 't Hoen, brook baker, Kaitlin Mara, Inka Heikkinen, Frank Cobelens, Anne-Mieke Vandamme, Jolene Skordis, Elil Renganathan, Mario Raviglione, Till Barnighausen, Pramiti Parwani, Fatima Suleman, Anniek de Ruijter, Ivan Demchenko, Valentina Mazzanti, and others. #PharmaceuticalRegulation #GlobalHealth #EuropeanUnion #AccesstoMedicines Thanks to Crescendo Consulting for the graphic. Aäron Blomme, MBA, MMA

The Regulatory Affairs Networking Cocktail Theme: The World Health Organization Global Benchmarking Tool Assessment of National Medicines Regulatory Authorities (NMRAs) and its Role in Pharmaceutical Systems Strengthening. Access to safe, quality and efficacious medicines for all in the African continent is still a vision awaiting realization. The health security of Africa is still challenged by diseases which can be prevented or treated with timely access to appropriate and affordable medicines, vaccines and other health services, yet stringent regulatory policies present challenges to access to medicines. In response to regulatory challenges, a number of regional harmonization efforts have been introduced by African Union through the African Medicines Regulatory Harmonization (AMRH) initiative. We also acknowledge the use of the WHO global benchmarking tool (GBT), a primary means by which WHO assesses regulatory systems for the regulation of medical products. Drawing from this, we have curated the Regulatory Affairs Networking Cocktail, where stakeholders come together for the purpose of working together towards a common goal, how can more African NMRAs adopt and benefit from the use of the WHO GBT? Join us on August 9, 2024 at The Concord Hotels, Beach Villas, and Game Lodges for an engaging & enlightening Networking Cocktail. Register: https://lnkd.in/dGPbnD_j #PharmaceuticalSystemsStrengthening

The Regulatory Affairs Networking Cocktail Theme: The World Health Organization Global Benchmarking Tool Assessment of National Medicines Regulatory Authorities (NMRAs) and its Role in Pharmaceutical Systems Strengthening. Access to safe, quality and efficacious medicines for all in the African continent is still a vision awaiting realization. The health security of Africa is still challenged by diseases which can be prevented or treated with timely access to appropriate and affordable medicines, vaccines and other health services, yet stringent regulatory policies present challenges to access to medicines. In response to regulatory challenges, a number of regional harmonization efforts have been introduced by African Union through the African Medicines Regulatory Harmonization (AMRH) initiative. We also acknowledge the use of the WHO global benchmarking tool (GBT), a primary means by which WHO assesses regulatory systems for the regulation of medical products. Drawing from this, we have curated the Regulatory Affairs Networking Cocktail, where stakeholders come together for the purpose of working together towards a common goal, how can more African NMRAs adopt and benefit from the use of the WHO GBT? Join us on August 9, 2024 at The Concord Hotels, Beach Villas, and Game Lodges for an engaging & enlightening Networking Cocktail. Register: https://lnkd.in/dGPbnD_j #PharmaceuticalSystemsStrengthening

Is the FDA the Gold Standard? A Global Perspective on Drug Approval The FDA has long been considered the gold standard for drug approval. However, the WHO SRA Collaborative Registration Procedure (CRP) offers a compelling alternative, particularly for global health equity. Here's why the CRP deserves more attention: * Global Focus: Prioritizes diverse populations, especially in low- and middle-income countries. * Collaborative Approach: Leverages expertise from multiple stringent regulatory authorities. * Equity-Centered: Improves access to essential medicines in resource-limited settings. * Broader Data Consideration: Adapts to varied healthcare contexts. * Efficiency: Reduces time and cost for approvals, especially in resource-constrained regions. * Sovereignty with Support: Empowers national regulatory authorities while leveraging global expertise. * Public Health Priorities: Focuses on neglected diseases and pandemic preparedness. * Transparency and Collaboration: Fosters open sharing of evaluations among stakeholders. * Adaptability: Can quickly respond to global health emergencies. * Proven Results: Has accelerated access to essential medicines in over 23 countries. Let's discuss: * Do you believe the CRP is a more effective model for global drug approval? * What are the potential challenges and limitations of the CRP? * How can we further strengthen international collaboration in drug regulation? #globalhealth #drugregulation #WHO #FDA #publichealth #healthcare #pharma #biotech

📣 Join the webinar on the acceptability of NDAs/MAAs with only Chinese patients by Western regulatory agencies 📅 June 27, 3 PM CET Register here: https://lnkd.in/dQm8msmr More and more data from Chinese patients are used in NDA/MAA submissions, and sometimes, only clinical data from China is provided. Discover the challenges, opportunities, and how PLG will be able to support your clinical trials in China. Check out the 7th installment of the ProductLife Group-Zwiers Regulatory Consultancy BV Product Development webinar series hosted by Dr. Sougat Sarkar, General Manager Clinical Development. #regulatoryagencies #nda #maa #clinicaltrials #clinicaldata #pharma #lifescience #healthcare #webinar

I'm thrilled to share that I will be presenting at DRUG INFORMATION ASSOCIATION (DIA) Europe 2025! This event brings together global leaders to discuss the latest advancements and challenges in drug development and regulatory science. I will be discussing technological challenges in clinical trials that have been seen by the FDA during inspections. I'm looking forward to contributing to the conversation, exchanging ideas, and collaborating with fellow professionals dedicated to improving health outcomes worldwide. #DIAEurope2025 #HealthcareInnovation #RegulatoryAffairs #ClinicalResearch #PatientSafety #Pharmcaeuticals #GlobalHealth #GCP #GLP #GVP

The draft decision of the Council of the EurAsian Economic Commission "On Amending subparagraph "a" of paragraph 1 of Decision No. 96 of the Council of the EurAsian Economic Commission dated June 10, 2022" has been published on the legal portal of the EEC Board for public discussion. It addresses the likelihood of deficiency in #medicines, decreases in #drug safety, and interruptions in the flow of medicines within the #EAEU in the context of established international relations. The purpose of the draft decision is to extend from January 1, 2025 to December 31, 2027 the period during which the authorized bodies of Member States of the Union may establish a temporary procedure for the circulation of medicines. To protect the life and health of the citizens of the member states by ensuring the #registration of medicines in accordance with established international relations on the external perimeter of the EAEU territory. According to the proposed regulation, the authorized bodies of member states will have the right to create a temporary procedure for the circulation of medicines until December 31, 2027. This will ensure that the registration of medicines is carried out within the conditions of established international relations on the external borders of the EAEU territory, so that the population's health and life can be protected. Until January 3, 2025, the draft decision will be open to public discussion. #pharmaceutical; #healthcare; #marketaccess

Monique Mantovani shared invaluable insights during the panel session "Key Note: Unveiling the Keys to Local Production in LatAm" at Biosimilars LatAm - Colombia 2024. She emphasized the importance of dialogue with local regulatory agencies like #ANVISA, highlighting how such discussions can streamline the #biosimilar registration process and pave the way for local production. 🌟💬 Let's continue fostering these partnerships to streamline biosimilar registrations and enhance healthcare accessibility. LIBBS FARMACÊUTICA LTDA #BiosimilarsLatAm #Colombia2024 #HealthcareRegulation #CollaborativeEfforts #RegulatoryDialogue #LocalProduction

Access to safe, effective, quality diagnostics, therapeutics and vaccines is a critical benchmark to measure the quality healthcare of any given populace. Regulatory systems play a key role in assuring the quality, safety, and efficacy of medical products and timely access to patients when needed. Within the African context; lack of access to quality, safe, efficacious and affordable medical products have posed a significant challenge to public health for countries, in part, this is attributed to weak or absent policies and regulatory systems. The WHO GBT assessment tool has plays a critical role in ensuring NMRAs identify their areas of strength as well as areas for improvement and build effective and resilient systems by implementing functional Institutional Development Plans (IDPs). During the Regulatory Affairs Networking Cocktail we will be delving into a this much needed discussion on The World Health Organization (WHO) GBT Assessment for NMRAs and its Role in Pharmaceutical Systems Strengthening in Africa. So far African countries have benefited from this intervention but what more does this mean for the health status in Africa. Register: https://lnkd.in/dA2niCC8 Date: August 9, 2024 Venue: The Concord Hotels, Beach Villas, and Game Lodges , Nairobi, Kenya. #PharmaceuticalSystemsStrengthening #TheWHOGBTAssessment