Bruno da Costa Ferraz

🔍 𝗪𝗵𝗮𝘁 𝗗𝗼𝗲𝘀 𝗚𝗠𝗣 𝗠𝗲𝗮𝗻? Good Manufacturing Practice (GMP) is an essential requirement covering every aspect of manufacturing and testing to ensure quality and mitigate potential risks to patients. At Servier Ireland, we integrate GMP requirements into all aspects of our operations to ensure compliance because Patient First, Safety Always. 𝗗𝗼 𝘆𝗼𝘂 𝗸𝗻𝗼𝘄 𝘁𝗵𝗲 𝟱 𝗺𝗮𝗶𝗻 𝗰𝗼𝗺𝗽𝗼𝗻𝗲𝗻𝘁𝘀 𝗼𝗳 𝗚𝗠𝗣? 🔹 People: Understand roles and responsibilities and ensure appropriate training. 🔹 Products: Maintain clear specifications for materials and product at every production phase. 🔹Processes: Ensure process are clearly documented and adhered to. 🔹Procedures: Follow simple, and consistent clear guidelines. 🔹Premises: Maintain cleanliness and calibrate equipment.

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Reflecting on Medicines for Europe Annual Conference which took place last week. We were delighted to bring together industry leaders from across Europe with the aim of enhancing patients' access to essential medicines. It was great to also be joined by key stakeholders from Ireland to further discuss the generic, biosimilar and value added medicines industry. Opening the event, Medicines for Ireland Chairperson Paul Neill emphasised the value that that off-patent medicines industry delivers to patients and healthcare systems across the continent. It is noteworthy that Medicines for Europe members supply an impressive 70% of all medicines in Europe. This statistic represents millions of patients who have received treatment that enables them to lead more fulfilling lives. It also highlights the savings that the State can reinvest in health systems and underscores the untapped potential that further support for our industry could mean for member states across Europe. Over the past decade, Ireland has witnessed significant growth in the adoption of off-patent medicines. Yet, there is still untapped potential. We are thankful to the Irish and European stakeholders who attended and participated in the Conference, MFI will continue to constructively engage with the policymakers, the health service and the regulator to further increase the penetration of generic, biosimilar and value added medicines to realise positive outcomes for both patients and the State. The conference outlined the importance of collaboration across Europe in shaping the future of the industry for the benefit of patients and member states. You can read more about it here ⬇ https://lnkd.in/eXbdzfus #MedsforEU24 #AccessForAll #BreakingBarriers Pinewood Healthcare Consilient Health Teva Pharmaceuticals Accord Healthcare Clonmel Healthcare Fresenius Kabi Celltrion Inc Rowa/Rowex Pharmaceuticals Ltd Sandoz Fannin Ltd DCC Vital Viatris

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Changing environment might be a challenge for foreigner companies trying to operate in Albania with or without local representation. Here at Onyx Pharma we try to be supportive with information sharing proactively and reactively as needed. Follow our page for continues information on events and important market dynamics. #healthcareenvironment

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This REVEAL GENOMICS, S.L., #UmbertoVeronesiFoundation and IEO Istituto Europeo di Oncologia study assesses the use of HER2DX in real-world treatment decision making for patients with early stage (1-3) HER2+ breast cancer. Studies so far investigating HER2DX have been in the clinical trial setting. The following questions will be addressed: ·        How do oncologists use HER2DX results in their neoadjuvant treatment plans for this patient population? ·        What are the associated outcomes (clinical, pathological, response)? Also, here is a link to background information on the HER2DX test, along with clinical trials. https://lnkd.in/g6WrWRJs

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Medicines for Ireland launches new 2024 – 2029 Vision Strategy, Looking Forward: Building the framework for a sustainable generic, biosimilar and value – added medicines industry in Ireland. In developing its new Vision Strategy 2024 – 2029, MFI member companies focused on three core strategic pillars: Enhanced Patient Access Resilient Supply Chain Sustainable Practices Paul Neill, Chair of Medicines for Ireland, stresses the urgency of this strategy amidst rising healthcare challenges, highlighting the potential for significant savings and improved patient care with the increased adoption of generics, biosimilars and value added medicines. Read the full strategy here: https://lnkd.in/ehVuWFsF In addition, we are delighted to announce that Deirdre Kelly, Country Manager, Consilient Health Ireland and Malta, has been appointed as MFI Vice Chair. #ConsilientHealthIreland #MedicinesForIreland #HealthcareInnovation #PatientCare #SustainableHealthcare #Ireland Job bag code: IE-CH-1569 Date of Preparation: April 2024

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#ClinicalTrials | Italian Medicines Agency provides clarifications in relation to the introduction of decentralised elements in clinical trials. The scope of this guideline, which confirms full applicability in Italy of relevant EU recommendation/guidelines, concerns organisational aspects. It provides some clarification, applicable at domestic level only, with regard to the introduction of decentralised elements in clinical trials that are (already) provided for by EU regulations/guidelines or that are not expressly prohibited. Read the full Insight → https://lnkd.in/dzR9aTHq ✏ Maria Grazia Medici ✏ Gianluigi Marino #AIFA

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EORTC - European Organisation for Research and Treatment of Cancer - Challenges and opportunities of conducting investigator-initiated clinical trials in Portugal Ana Joaquim https://lnkd.in/e-hu9-W3 #CancerResearch #ClinicalTrials #OncoDaily #Oncology #Cancer #Health #Medicine

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At the annual European Society for Medical Oncology (ESMO) congress in Barcelona, Spain, Illumina brought together oncologists, patient advisory groups, clinicians, and researchers to discuss the growing evidence on the benefits of comprehensive genomic profiling (CGP) using liquid biopsy, and how it can help to inform therapy decisions and improve patient care. This revolutionary technique uses a blood test to detect circulating tumor #DNA, which is then sequenced to assess multiple biomarkers in numerous tumor types using a single next-generation sequencing assay. This process is less invasive for patients, requiring a one-time test rather than multiple biopsies, which can add to the patient’s discomfort and prolong the wait for a diagnosis. #illuminaproud #genomics #makeadifference

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🌍 Exciting News for Bladder Cancer Care in Europe! 🚀 Earlier this week an announcement of a strategic partnership between A.Menarini Diagnostics S.r.l. and Nucleix Ltd. was made to bring the Bladder EpiCheck® test, a non-invasive solution for detecting and monitoring bladder cancer, to Europe! Chris Hibberd outlined "We are excited to expand the Bladder EpiCheck® market in Europe with A. Menarini Diagnostics, a trusted partner in delivering innovative diagnostic solutions," Bladder cancer is the sixth most common cancer in Europe, with approximately 760,000 people currently living with the disease. Surveillance is crucial for NMIBC patients due to the high recurrence rates and potential progression to more severe conditions. This partnership is set to revolutionise bladder cancer care in Europe, providing a less invasive and more efficient option for patients and healthcare systems alike. Together, they are committed to advancing early detection and transforming cancer care for the better. #MenariniDiagnostics #Nucleix #Diagnostics 

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Interesting article about Medical technology in Ireland: Trends and innovations #medicaldevice #ireland #medicalsales #medicalthechnology #healthcare #pharmaceutical #pharmaceuticalindustry #phramasales https://lnkd.in/e8iCziBe

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IPHA is calling for the next Government to commit to a continuous and faster flow of new life-enhancing medicines and vaccines for patients in Ireland.    Medicines development is constantly changing and transforming how patients can be treated. Patients in Ireland need and deserve to be able to access these new treatments faster. We believe that all patients on the island of Ireland should have access to new medicines that are approved for the EU and UK. And when it comes to receiving these life-enhancing medicines, it should not matter if you are a public or private patient.    That is why we are calling for a new voice for doctors in prioritising new medicines for patients in our #NewMedicinesPledge.  Find out more here https://bit.ly/3AyYq3y Stephen Donnelly Simon Harris Micheál Martin Paschal Donohoe Jack Chambers Sinn Féin

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🎉Today is the day! 🇪🇺The new EU Regulation on Health Technology Assessment (HTA) is now in effect, ensuring faster access to innovative medicines and medical devices for patients across Europe. 🌍 Learn more at the European Commission website https://lnkd.in/e3XbtUCm

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Ireland is often referred to as a gateway to Europe - the closest European country to the US - and one of the most open and globally connected countries. Yet, more companies choose other similar-sized markets, like Denmark and Finland, to conduct clinical research. A recent report from IPHA (Irish Pharmaceutical Healthcare Association shows that Ireland continues to lag peer European countries in attracting clinical trials. Click here to read the report https://lnkd.in/dafuiA45

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🚨 EU-CTR Transition Deadline Alert: 31st January, 2025 🚨 By 31st January 2025, all clinical trials initiated under the EU Clinical Trials Directive (2001/20/EC) must transition to the EU Clinical Trial Regulation (EU-CTR 536/2014). This marks the end of the transition period and the full implementation of EU-CTR, ensuring harmonised and streamlined clinical trial processes across Europe. What does this mean for Regulatory Affairs teams? Do you have the right staff in place to guarantee compliance? To meet this critical deadline, here are the key actions to focus on: 1️⃣ Audit and Identify Trials Review your portfolio to identify all ongoing trials initiated under the Directive. Determine their readiness for transition to the EU-CTR framework. 2️⃣ Prepare for CTIS Migration Transition all applicable trial documentation and approvals into the Clinical Trials Information System (CTIS). Ensure your team is well-trained on CTIS functionalities for seamless submissions and updates. 3️⃣ Update Regulatory Documents Align trial documentation, including protocols and informed consent forms, with the EU-CTR requirements. Address any gaps in safety reporting, transparency, and monitoring protocols. 4️⃣ Engage with Stakeholders Collaborate with sponsors, CROs, and ethics committees to ensure mutual understanding of the transition requirements. 5️⃣ Ensure Compliance with Transparency Requirements EU-CTR emphasizes public transparency of clinical trial data. Prepare for the publication of trial summaries and results in CTIS. This transition represents a significant shift toward greater efficiency, consistency, and public accountability in EU clinical trials. While the deadline is firm, proactive preparation will not only ensure compliance but also position your organization for success under this new framework. 🔎 Are your trials ready for the EU-CTR transition? 💡 Let’s connect to discuss how a contractor could make sure you are ready for 31st January 2025! #ClinicalTrials #RegulatoryAffairs #EUCTR #Compliance #ClinicalResearch #teampsp

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Regulatory Update 📢 The Italian Medicines Agency has activated the new consultation service of the “AIFA Medicines” medicinal products database. The service allows a faster and more accurate search of documents and information on medicines authorised in Italy. In addition to viewing and downloading the package leaflet and the Summary of Product Characteristics of medicines, citizens, healthcare professionals and companies may find information on the reimbursability of the medicine by the National Health Service (SSN), the supply regime and any shortages. 🔗 Read more here: https://zurl.co/v6Ur #regulatoryupdate #lifescience #AIFA #medicines #medicinesdatabase

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Regulatory Update 📢 The Italian Medicines Agency has activated the new consultation service of the “AIFA Medicines” medicinal products database. The service allows a faster and more accurate search of documents and information on medicines authorised in Italy. In addition to viewing and downloading the package leaflet and the Summary of Product Characteristics of medicines, citizens, healthcare professionals and companies may find information on the reimbursability of the medicine by the National Health Service (SSN), the supply regime and any shortages. 🔗 Read more here: https://lnkd.in/eu2b4Jr4 #regulatoryupdate #lifescience #AIFA #medicines #medicinesdatabase

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In this week's pharmaceutical industry news, significant investments, strategic partnerships, and innovative studies come to the fore. We have compiled the most prominent developments for you. 👇 Enjoy your reading! ✅#EliLilly is planning to invest a total of $1.8 billion in two manufacturing sites in Ireland, boosting its medicine production worldwide. https://lnkd.in/dNq2TKky ✅#Sanofi’s novel manufacturing unit in France shortens production timelines and enables rapid changes in production capacities for medicines such as biologics and vaccines. https://lnkd.in/dkd-fF_r ✅#NovoNordisk and NanoVation Therapeutics have entered into a multi-year partnership worth $600m to advance genetic medicines for cardiometabolic and rare diseases. https://lnkd.in/djhqPsJB ✅#Organon makes $1.2bn play for Roivant’s immuno-dermatology subsidiary. https://lnkd.in/dJFzVBVq ✅#Gilead has announced a strategic partnership with Genesis Therapeutics, aimed at using AI to discover and develop new small molecule therapies. https://lnkd.in/eEbkxQUF #pharmanews #strategyconsulting #pharmaceuticals #fitminds

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#PharmacovigilanceBulletin by the Slovenian Medicine Agency Our Medicine Agency (JAZMP) started issuing a free electronic newsletter for healthcare professionals, which summarizes new medicine safety announcements and important changes to medicine information. The Bulletin will be issued quarterly. Looking forward to new issues.😀 #pharmacovigilance #PV #medicine

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