🚨1 week left to book!🚨 Learn how to prepare and manage #pharmaceutical (#CMC) information the #regulatorydossier’s Module 3. Our Getting the CMC Dossier Right #CRED course will teach you the common pitfalls to avoid as well as being given the opportunity to interact with speakers from regulatory agencies in a neutral environment. By attending this in-person #trainingcourse on 4-5 September 2024 in #London, UK, you will: 🔹 Gain a comprehensive overview of the requirements for Module 3 of the regulatory dossier 🔹 Participate in case studies and interactive lessons 🔹 Build a network that will support you for the rest of your career 🔹 Earn 14.5 #CPD hours Led by #expertspeakers, this course is suitable for less experienced #regulatoryaffairs professionals who require comprehensive information on CMC, as well as experienced professionals who are new to CMC. Book now 👉 https://lnkd.in/eVk5gJ87 This course is part of our programme of CRED courses which are for experienced professionals committed to developing their regulatory and management competencies. Discounted rates are available for those working for regulatory or government agencies, academic institutions, charities, patient groups, or in full-time education.
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#Didyouknow If you are involved in #clinicalresearch projects and the design and management of #eCFs, this document is of interest to you! The #eClinicalForum, an international, non-profit group representing primarily the #pharmaindustry and #biotech has released 7th public version of the Requirements for Electronic Data for Regulated Clinical Trials (eCF Requirements). The document outlines the requirements and guidance directions that pertain to #electronicdata and #electronicsystems that support clinical research and delivers 37 statements to enable conformity with #regulatoryrequirements of FDA, European Medicines Agency, #Japan's #PMDA, #China's #MNPA, Medicines and Healthcare products Regulatory Agency and #ICH. This version (V2023.3PR) is a significant update as it incorporates the latest requirements from the 2023 EMA Guideline on #computerisedsystems and electronic data in clinical trials (available here: https://lnkd.in/dYScwNpU) 𝐀 𝐟𝐫𝐞𝐞 𝐩𝐮𝐛𝐥𝐢𝐜 𝐰𝐞𝐛𝐢𝐧𝐚𝐫 𝐭𝐨 𝐝𝐢𝐬𝐜𝐮𝐬𝐬 𝐡𝐨𝐰 𝐭𝐡𝐞𝐬𝐞 𝐞𝐂𝐅 𝐑𝐞𝐪𝐮𝐢𝐫𝐞𝐦𝐞𝐧𝐭𝐬 𝐚𝐫𝐞 𝐛𝐞𝐢𝐧𝐠 𝐮𝐬𝐞𝐝 𝐭𝐡𝐞 𝐢𝐧𝐝𝐮𝐬𝐭𝐫𝐲, 𝐰𝐢𝐥𝐥 𝐛𝐞 𝐡𝐞𝐥𝐝 𝐨𝐧 𝐒𝐞𝐩𝐭 18, 2024. Register here: informationhttps://lnkd.in/g4iPa4ta #clinicalinvestigations #clinicaltrials #clinicalstudies #medtech #pharma
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🌍 Meet Alusine Ambrose, a healthcare professional from Sierra Leone, whose approach to his work was impacted by the CLC 1 Supply Chain for Health course. From managing pharmaceutical supplies during the Ebola crisis to becoming a research pharmacist, Alusine shares how the CLC course empowered him to tackle supply chain challenges with confidence. 💡 "Before this course, I was working blindly. Now, I understand the correct ways to do things. It's opened my horizon to a new atmosphere." Read more about Alusine's inspiring story and the important role of the CLC course training on his work: https://lnkd.in/eHerAgXQ PSSL #SupplyChain #BeeSkilled #Elearning #CapacityBuilding #HealthWorkforce #LeadershipDevelopment #HealthcareInnovation #PublicHealth #GlobalHealth #SkillDevelopment #HealthSystemsStrengthening
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In clinical research, Phase 4 is the post-marketing surveillance phase. It involves monitoring the drug or treatment after it's been approved and made available to the public to ensure its safety and effectiveness in real-world settings. #clinicalresearch #clinicaltrials #cpa #communitypharmacistaid #pharmacy #clinicalstudies #certification #student
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Pharma #Book 270 pages valuable guide for Pharma Professionals FREE Downladoable in #Pharma and #medical resources courses and events group https://lnkd.in/eUXFKGY2
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Pharma #Book 270 pages valuable guide for Pharma Professionals FREE Downladoable in #Pharma and #medical resources courses and events #group ⬇️⬇️⬇️ https://lnkd.in/eUXFKGY2
Pharma #Book 270 pages valuable guide for Pharma Professionals FREE Downladoable in #Pharma and #medical resources courses and events #group ⬇️⬇️⬇️ https://lnkd.in/dwJFHdAx
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The U.S. Inflation Reduction Act (IRA) and E.U.'s Joint Clinical Assessment (JCA) together constitute the most consequential legislative shift for the pharma industry in decades, requiring the industry to answer more challenging questions within shorter timeframes. Are companies underprepared? How might they adapt? In this new, joint article by Wickenstones Ltd and WittKieffer, the authors explore the challenges of the IRA and JCA and share insights for how pharma companies can expand their readiness in terms of: Culture, Competency and Capacity, Structure and Governance, and Market Access. The new legislation "pushes the pharmaceutical industry towards a more functionally integrated operating model. Fully integrated teams, which bring clinical development and regulatory affairs into closer alignment with market access from the beginning of asset development, lead to efficiencies and enhanced outcomes." In essence, the IRA and JCA bring "opportunities for the industry to evolve, adapt, and future-proof its operating model." Reach out to the authors! Luigi Frezza, Eddie Gibson, Dingeman Wolfert, Owen Daykin-Pont #pharma #pharmaceuticalregulation #lifesciences #pharmaoperations
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Pharma #Book 270 pages valuable guide for Pharma Professionals FREE Downladoable in #Pharma and #medical resources courses and events #group ⬇️⬇️⬇️ https://lnkd.in/dwJFHdAx
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Missed our last LIVE ACMA webinar? Watch the full session, "Maximizing Impact: The Value of Board Certification for Medical Affairs and MSL Professionals." with Emmanuel Caillaud, Julio J Fernandez, PharmD, RPh, MBA, BCMAS and Kiana Dixson, PharmD, BCMAS. Discover how board certification can enhance your professional credibility and career opportunities. Learn about key competencies, practical strategies for certification, and why it's crucial for every pharmaceutical company to consider board certification for mitigating risk: https://lnkd.in/eruBGX2S #MedicalAffairs #MSL #BoardCertification #CareerAdvancement #PharmaceuticalIndustry #ProfessionalDevelopment #Webinar #PharmaCareers
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📢 The The Association of the British Pharmaceutical Industry (ABPI) has issued a challenge to all political parties: unlock the potential of the UK life sciences industry to drive health and economic growth! 🌟 With £9 billion invested in UK R&D in 2022, the pharmaceutical industry is the largest investor, delivering £16.4 billion in economic value and supporting 126,000 high-skilled jobs across the country. ABPI's ‘Manifesto for Investment, Health, and Growth’ outlines a plan to boost patient access to new medicines, create more high-quality jobs, and enhance the UK's economic growth. The next government could: - Drive a 40% decrease in the total UK burden of disease - Generate £16.3 billion and 85,000 new jobs annually from increased pharmaceutical exports - Attract an additional £1.2 billion and 7,000 high-quality jobs annually from greater life sciences foreign direct investment - Create 17,000 jobs each year from more UK life sciences IPOs The benefits would be seen nationwide, as demonstrated by ABPI’s Pharma Impact Map. Read more on the ABPI website and join us in supporting this vital sector. Read more https://ow.ly/qwVq50SooLr #LifeSciences #UKHealth #EconomicGrowth #ABPI #HealthcareInnovation
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