Maria De Maglie

🔍 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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Speaking at Pharmig microbiology conference about my two favourite topics: Quality Risk Management and Sterility Assurance

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Opportunity

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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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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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Generic, biosimilar and value-added medicines are revolutionising Ireland's healthcare!   Speaking at a recent panel discussion during Medicines for Europe Annual Conference, MFI Vice-Chairperson Deirdre Kelly noted the advancements that have been made within the generic, biosimilar and value-added medicines medicines industry.   During the debate, Deirdre shared how the perception of off-patent medicines has evolved since their introduction to the Irish healthcare system. Legislative changes in 2013 heralded the introduction of generic substitution and referencing pricing. This was followed up by other policy initiatives such as the Best Value Biologic program and updates to the community pharmacy database to facilitate increased generic dispensing and biosimilar prescribing. These advancements have resulted in an acceleration of generic medicines in Ireland, with uptake just shy of 60%. Significantly ahead of where it was 10 years ago, but still below the European average.     The off-patent medicines sector is already a significant driver of effective and efficient medicines usage in Ireland - but there is more to be done!   Changes are needed at both the EU and National levels to encourage growth. The current EU pharma legislation, particularly the Bolar exemption, can play a significant role in optimising the industry. By removing any barriers to launch on day 1 of originator patent expiry, there is an opportunity for more effective use of off-patent medicines, thereby increasing effective and efficient medicine usage.    Like many other sectors, the off-patent sector is also experiencing a significantly increasing cost base with reducing prices and tight profit margins. Working with stakeholders, particularly around expanding the current pricing framework to consider concepts such as tiered pricing, incentivisation and automatic indexation as part of more long-term medicine pricing strategies, will help ensure a competitive environment into the future.    MFI will continue to engage with relevant stakeholders in the Department of Health, HSE and HPRA to highlight the value created for patients and the State by the off-patent industry.    Looking ahead, MFI's 5-year vision emphasises sustainable pricing strategies, incentivising biosimilar uptake and creating a regulatory and pricing framework for value-added medicines. Increasing accessibility, affordability and sustainability is at the heart of our policy and will continue to guide us as we continue to engage with all stakeholders on the future of this industry.    #MedicinesForAll 

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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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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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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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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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EMA: Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level – Human medicines requirements. Key changes: Czech Republic: Requirements were revised and updated, detailing qualifications and responsibilities for LPPV. Denmark: LPPV nomination was deemed non-mandatory as per the summary of requirements. Estonia: Requirements were updated to include the appointment of LPPV in relation to RMMs, specifying responsibilities regarding RMMs. Germany: Detailed specifications for StufBA requirements were provided, and additional references were included. Romania: Nomination requirements for LPPV were changed to non-mandatory. Slovakia: A notification submission route was added. Spain: Nomination requirements for LPPV were updated and described in more detail. France, Hungary, Portugal: veterinary parts were removed.

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In a powerful new article in The Irish Times, Andres Rodrigo highlights the importance of accelerating access to new medicines in Ireland. Explaining the importance of sustained funding and the benefit of targeted resource allocation, Andres outlines two key steps that can bridge the gap between innovation and patient care. Read the full article now here: https://bit.ly/4dKJxJy #PharmaLeadership #HealthcareInnovation #IrelandHealth #PatientCare

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"Article 1 Subject matter This Regulation lays down detailed procedural rules concerning cooperation, in the form of exchange of information, of the Member State Coordination Group on Health Technology Assessment (‘Coordination Group’), with the facilitation of the secretariat of the Coordination Group (‘the HTA secretariat’), with the European Medicines Agency on the joint clinical assessment and joint scientific consultation referred to in Articles 7 to 21 of Regulation (EU) 2021/2282 as regards: (a) planning and forecast of the joint clinical assessments and joint scientific consultations; (b) identification of patients, clinical experts and other relevant experts (‘individual experts’) to be involved in joint clinical assessments and joint scientific consultations; (c)horizontal scientific and technical matters related to joint clinical assessment and joint scientific consultation; (d)security of sharing and protection of confidential information exchanged between the European Medicines Agency and the HTA secretariat and then shared by the HTA secretariat with the Coordination Group or its subgroups and their members within the context of joint clinical assessment and joint scientific consultation"

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Great insights indeed Anders, and I hope such data will be helpful to bring attention to such opportunities. I also think we are just scratching the surface here - for example - the question about "effective lessons learned in place" has a generally favorable response but there is work yet to do - my empirical data suggests "spreadsheets are where lessons go to die..." Said differently, we are fairly good at capturing lessons - whenever I survey a room, +80% have participated in LL. However, when I ask if people have sought prior lessons to inform new work, only ~5-10% say they do. A lesson isn't truly learned until it drives a change in behavior. Another huge opportunity for continuous improvement and a growth mindset our industry.

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Medicines for Ireland believes that biosimilar medicines can play a vital role in overcoming the challenges that the medicines industry faces today. Establishing a sustainable pathway for biosimilar medicines can increase access to vital medicines that will benfit both state and patients. There are several opportunities to address the barriers and challenges facing biosimilar medicines, such as low uptake, lack of incentives, and regulatory uncertainty. Therefore, MFI proposes the following actions to establish a sustainable pathway for biosimilar medicines in Ireland. There is a requirement for a fair and transparent pricing mechanism for biosimilar medicines that reflects their value and quality and ensures a suitable position for new biosimilars to launch. MFI and our member companies operating in the biosimilar space will continue to build the required recognition of the BVB model's success by amplifying the increased uptake of biosimilar medicines in Ireland and urging the HSE to give due consideration to expanding this model to other therapeutic areas, encouraging prescribers to utilise biosimilar medicines. Finally, we will work with the HPRA and the HSE to implement faster and more efficient reviews of biosimilar medicines. This would significantly reduce the time to market and increase the availability of vital biosimilar medicines for Irish patients. Medicines for Ireland wants to highlight the value biosimilars can provide to the State, enabling the industry to provide high-quality care to patients. However, sustained action is required to address sustainability challenges. MFI and our members are ready and willing to engage with all stakeholders in order to continue providing for patients. Find out more about our vision for the Biosimilar, Off-patent and Value added medicines industry here ⬇️ https://lnkd.in/ekJfxT7Q Viatris Clonmel Healthcare Accord Healthcare Celltrion Inc Consilient Health Fannin Ltd Fresenius Kabi Teva Pharmaceuticals #Medicinesforall

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Colonis Commercial Director Michael Dobson and Product Manager Fiona Wiles are attending 30th Medicines for Europe conference later this week in Dublin, where they will be exploring further opportunities for innovation in value-added medicines (VAMs).   Medicines for Europe have a mission to establish, in collaboration with patients, healthcare professionals and payers, a sustainable market model that incentivises R&D and access to VAMs. Here at Colonis Pharma we understand the importance of VAMs which contribute to addressing unmet patient needs, moving from a one-size-fits-all to a more patient specific approach. This is why we are continually investing in the repurposing and reformulation of existing drugs.     Find out more about VAMs at: https://lnkd.in/ef2Mhdch   #Pharmaceuticals #ValueAddedMedicines #MedicinesForEurope

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