The definition of Unmet Medical Need (UMN) is a provision in the EU Pharmaceutical Legislation. Are you prepared for the implications? DIA Europe 2024 tackled this question in a session now available on-demand for FREE! This session dives into the UMN concept, exploring current perspectives, proposed new definitions from the revised legislation, and future challenges and opportunities. Gain valuable insights to stay ahead of the curve in your regulatory strategy. Watch it today: https://bit.ly/4fblkgY. Looking for more? Mark your calendars for DIA Europe 2025! Stay tuned for updates and check out our website for more information: https://bit.ly/3LmbH19. #DIAEurope #RegulatoryStrategy #UMN #UnmetMedicalNeed #PharmaRegulation
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Corporate Partner | Legal 500 Next Generation Partner | Venture Capital, M&A, ECM & JVs | Life Sciences, TMT & Deep Tech
New updates to the EU Pharmaceutical Reform! The European Parliament has adopted revised versions of the original two European Commission proposals 📄. Here, my colleagues Sally Shorthose and Sophie Vo explore the proposed changes to marketing authorisation (MA) procedures in the EU, including reduced application timelines, the broader scope of centralised MAs and the ability to opt into the decentralised and mutual recognition procedures. Click here to read more on the proposed changes and what happens in the next legislation process: https://2bird.ly/47qSs0s #EUpharmaceuticalreform #EUpharma #pharma #lifesciences #legislation #law #reform
New updates to the EU Pharmaceutical Reform! The European Parliament has adopted revised versions of the original two European Commission proposals 📄. Our experts Sally Shorthose and Sophie Vo have explored the proposed changes to marketing authorisation (MA) procedures in the EU, including reduced application timelines, the broader scope of centralised MAs and the ability to opt into the decentralised and mutual recognition procedures. Click here to read more on the proposed changes and what happens in the next legislation process: https://2bird.ly/47qSs0s #EUpharmaceuticalreform #EUpharma #lifesciences #legislation
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New updates to the EU Pharmaceutical Reform! The European Parliament has adopted revised versions of the original two European Commission proposals 📄. Our experts Sally Shorthose and Sophie Vo have explored the proposed changes to marketing authorisation (MA) procedures in the EU, including reduced application timelines, the broader scope of centralised MAs and the ability to opt into the decentralised and mutual recognition procedures. Click here to read more on the proposed changes and what happens in the next legislation process: https://2bird.ly/47qSs0s #EUpharmaceuticalreform #EUpharma #lifesciences #legislation
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As part of our series of articles on the EU Pharmaceutical reform, Sally Shorthose and I cover the key changes being proposed for marketing authorisation procedures, as adopted by the European Parliament earlier this year. To see other articles in the series (which cover antimicrobial resistance, parallel imports, regulatory data and market protection, orphan medicines, etc), click here: https://lnkd.in/eWtUBgSp #EUpharmaceuticalreform #EUpharma #lifesciences
New updates to the EU Pharmaceutical Reform! The European Parliament has adopted revised versions of the original two European Commission proposals 📄. Our experts Sally Shorthose and Sophie Vo have explored the proposed changes to marketing authorisation (MA) procedures in the EU, including reduced application timelines, the broader scope of centralised MAs and the ability to opt into the decentralised and mutual recognition procedures. Click here to read more on the proposed changes and what happens in the next legislation process: https://2bird.ly/47qSs0s #EUpharmaceuticalreform #EUpharma #lifesciences #legislation
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Earlier this year in April, the European Parliament took a significant step by adopting its position on two European Commission proposals aimed at revising the EU's pharmaceutical legislation. Marc Martens and Benedicte Mourisse take a look at this important development and summarise the key points in relation to the new directive and regulation, notable changes in legislation, timeline and Parliament’s position in regards to supporting enhanced patient access, innovation and research: https://lnkd.in/e3SMpmb3 #HealthcareInnovation #PharmaIndustry #EUParliament #AntimicrobialResistance
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The European Commission’s proposed revision to the EU pharmaceutical legislation has taken another step forward after the European Parliament adopted its position on the draft text, which includes a seven and a half year baseline regulatory data protection period. https://lnkd.in/ePqciFCV #eu #euparliament #pharma #pharmalegistation
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📢 Stay informed with the latest developments in the pharmaceutical industry. 🔦 European Parliament members have approved a revised version of the "pharmaceutical package" initially released by the European Commission in April 2023. 📖 The new legislation, one of the major changes compared to the commission’s proposal, is a less severe reduction in the baseline period of regulatory data protection. According to parliament members, the baseline period of regulatory data protection should be cut to seven and a half years from eight at present. 🌏 https://lnkd.in/dznKAakj #PharmaNews #MarketAccess #EUHTA
EU Parliament Adopts Updated Pharma Package Despite Some Political Disagreement
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Regulatory intelligence and competitive strategy - what you need to know!
Dive into the world of regulatory strategy with our experts, Romain Kherrat, Sofia Ataide, and Yanbing Bertho. Join us on May 14 at 4 pm CEST for a new webinar, 'Shaping Regulatory Strategy: Unleashing Competitive Insights with Contextual Regulatory Intelligence.' Discover the latest global drug approval trends, explore recent pharmaceutical regulation developments, and get an insider's view into the life of a regulatory strategist. Unlock valuable competitive insights using our cutting-edge regulatory intelligence powered by GenAI. Register now: https://lnkd.in/dDRUARAZ #regulatoryaffairs #regulatory #GenAI
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53% of pharma CEOs report regulatory changes as a top disruptive trend! This webinar is a fantastic opportunity to stay ahead in the ever-evolving regulatory landscape and gain valuable insights to enhance your strategies.
Dive into the world of regulatory strategy with our experts, Romain Kherrat, Sofia Ataide, and Yanbing Bertho. Join us on May 14 at 4 pm CEST for a new webinar, 'Shaping Regulatory Strategy: Unleashing Competitive Insights with Contextual Regulatory Intelligence.' Discover the latest global drug approval trends, explore recent pharmaceutical regulation developments, and get an insider's view into the life of a regulatory strategist. Unlock valuable competitive insights using our cutting-edge regulatory intelligence powered by GenAI. Register now: https://lnkd.in/dDRUARAZ #regulatoryaffairs #regulatory #GenAI
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Dive into the world of regulatory strategy with our experts, Romain Kherrat, Sofia Ataide, and Yanbing Bertho. Join us on May 14 at 4 pm CEST for a new webinar, 'Shaping Regulatory Strategy: Unleashing Competitive Insights with Contextual Regulatory Intelligence.' Discover the latest global drug approval trends, explore recent pharmaceutical regulation developments, and get an insider's view into the life of a regulatory strategist. Unlock valuable competitive insights using our cutting-edge regulatory intelligence powered by GenAI. Register now: https://lnkd.in/dDRUARAZ #regulatoryaffairs #regulatory #GenAI
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Corporate Consultant/Advisor | Corporate Laws Expert | Corporate Trainer | HR Consultant | Compliance’s Expert | AML Advisor | Legal Counsellor | Tax Advisor | Auditor | Author | Lecturer | Motivational Speaker | Poet
UPDATE BY #BOI (Prime Minister's Office) To facilitate the businesses in Pharmaceutical Sector, issuance and renewal of Drug License has been made time bound to make the process robust. For details: https://lnkd.in/dNxNKqwX #PRMI #RegulatoryReforsms #regulatorycompliance #investinpakistan #pharmaceuticalindustry #promotingdomesticindustry #localmanufacturers #genericdrugs #PakistanPharmaGrowth #HealthcareInnovation #DomesticIndustryRising #RisingDomesticPharma #InnovationInMedicine #HealthcareEvolution
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MPharm | Scientific Programs Manager at DIA | Students and Young Professionals Advocate
2moThis was SUCH an interesting session to watch! Regulators, European Commission, Patients and industry all discussing this at the same table 💥