BOLDSCIENCE’s Post

Our Goodwin Life Sciences Regulatory & Compliance team is pleased to share its Q3 2024 quarterly issue tracker which highlights important regulatory developments for drug and device companies, including their Boards and investors, and is key reading for public life sciences companies preparing to issue their Quarterly filings and updates. Click below and use the drop-down menus to view our Q3 issue tracker. #Goodwinlaw #regulatorycompliance #drugs #medtech

Clinical Trial 2.0, Knowledge series # 5- 20Jun2024 (Published every Thursday) Striking the right balance between Risk-Based Quality Management (RBQM) and clinical data science unlocks the potential for Risk-Based Clinical Data Science to advance next-generation Clinical Trials. The RBQM-CDS infinity loop seamlessly integrates RBQM components with clinical data elements. To know more, reach out to our RBQM & Data expert Mukesh Babu K to learn more about this approach. #clinicaltrials #clinicaldatamanagement #data #healthcare #innovation #patient #safety #regulatory #fda #rbm #rbqm #medical #ClinicalResearch #Biotech #Pharma #CRO #Innovation #SpecialtyServices #Agility #RegulatoryExcellence #Healthcare #Partnerships

Releasing the Arex Advisor 2023 Annual Report! “Looking back at the year 2023, we are lucky to say that, from Arex's viewpoint, it has been a fantastic year, despite the challenges the world is currently facing. We keep growing – thus our clients become stronger by tapping into more expertise. The team is now close to 40 people, and we are proud to be trusted to work on some of the most exciting projects in the life sciences. The interest in Arex Advisor’s services prevails and our growth shows that there is a significant need for qualified expertise in our field. This past year we have welcomed several new colleagues, predominantly within regulatory affairs and quality assurance, and we also gained experience in early clinical development. In this way, we have strengthened and broadened our service offer to meet the increased need of the industry. We are honoured by the trust our clients put in us and will keep making our contribution to improved patient health and lives.” Linda Thunell CEO Arex Advisor The complete annual report is available via link in comment. #arexadvisor #annualreport #regulatoryaffairs #cmc #qualityassurance #marketaccess #pharmacovigilance #pharma #biotech #consultancy

𝐅𝐃𝐀’𝐬 𝐅𝐫𝐞𝐬𝐡 𝐓𝐚𝐤𝐞 𝐨𝐧 𝐀𝐍𝐃𝐀 𝐀𝐦𝐞𝐧𝐝𝐦𝐞𝐧𝐭𝐬: 𝐒𝐭𝐫𝐞𝐚𝐦𝐥𝐢𝐧𝐢𝐧𝐠 𝐑𝐞𝐯𝐢𝐞𝐰 𝐂𝐲𝐜𝐥𝐞𝐬 The FDA has issued a fresh update to its guidance on 𝘢𝘮𝘦𝘯𝘥𝘮𝘦𝘯𝘵𝘴 𝘵𝘰 𝘈𝘣𝘣𝘳𝘦𝘷𝘪𝘢𝘵𝘦𝘥 𝘕𝘦𝘸 𝘋𝘳𝘶𝘨 𝘈𝘱𝘱𝘭𝘪𝘤𝘢𝘵𝘪𝘰𝘯𝘴 (𝘈𝘕𝘋𝘈𝘴) 𝘢𝘯𝘥 𝘗𝘳𝘪𝘰𝘳 𝘈𝘱𝘱𝘳𝘰𝘷𝘢𝘭 𝘚𝘶𝘱𝘱𝘭𝘦𝘮𝘦𝘯𝘵𝘴 (𝘗𝘈𝘚𝘴), aligning with the reauthorization of GDUFA III. This guidance revises the 2018 version and addresses comments from a 2022 public docket. 𝑲𝒆𝒚 𝒖𝒑𝒅𝒂𝒕𝒆𝒔: 𝑪𝒍𝒆𝒂𝒓𝒆𝒓 𝑪𝒍𝒂𝒔𝒔𝒊𝒇𝒊𝒄𝒂𝒕𝒊𝒐𝒏 𝒇𝒐𝒓 𝑫𝒆𝒇𝒊𝒄𝒊𝒆𝒏𝒄𝒊𝒆𝒔: The FDA has tightened the criteria for what qualifies as a “major deficiency,” meaning less ambiguity for manufacturers facing the dreaded Complete Response Letter (CRL). Now, the FDA will aim to resolve deficiencies during the assessment cycle through information requests (IRs) or discipline review letters (DRLs) before escalating them to a CRL. The focus is to avoid flagging deficiencies as “major” unless absolutely necessary. 𝑷𝒖𝒃𝒍𝒊𝒄 𝑰𝒏𝒑𝒖𝒕 𝑴𝒂𝒕𝒕𝒆𝒓𝒔: Industry and Trade Associations' voices (Public comments submitted after the FDA’s 2022 request for feedback) have applauded the FDA’s push for clarity, noting that some deficiencies previously considered major could reasonably be classified as minor. 𝑼𝒑𝒅𝒂𝒕𝒆𝒅 𝑨𝒎𝒆𝒏𝒅𝒎𝒆𝒏𝒕 𝑬𝒙𝒂𝒎𝒑𝒍𝒆𝒔: This new guidance also updates examples of major amendments, minor amendments, and priority assessments. It breaks down potential major deficiencies tied to drug substance, product process, microbiology, and bioequivalence. #GDUFAIII #GenericDrugs #FDAguidance #ANDA #FDA #Generics #Amendments

PHUSE's Real World Evidence Working Group have posted not 1, but 2 blogs this week! The first takes a closer look at the experiences shared within the dedicated Working Group in exploring the types of data quality hurdles encountered when using RWD. And the second delves into the key responsibilities sponsors should uphold when leveraging RWE in accordance with FDA regulations. Blog 1 – Understanding the Data Quality Issues in Real-World Data Through Real-World Examples https://lnkd.in/erAxy49e Blog 2 – Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products https://lnkd.in/gKh7grDe #PHUSE

At BioPharma Services Inc. we are committed to maintaining the highest standards of compliance and quality in our clinical trials. The recent draft guidance from the FDA on "Processes and Practices Applicable to Bioresearch Monitoring Inspections" highlights the critical role of Phase 1 CROs in ensuring data integrity and participant safety. 🔍 What does this mean for us? ✔️Enhanced Preparedness: We are ready for both announced and unannounced inspections, with robust records management and staff readiness. ✔️Best Practices Implementation: From pre-announcement communications to post-inspection follow-ups, we are dedicated to continuous improvement. ✔️Global Compliance: We adhere to international regulatory standards, ensuring consistency and reliability across all our operations. 🤝 What does this mean for our clients? ✔️Quality Assurance: Confidence that our data is accurate and reliable, having undergone rigorous FDA scrutiny. ✔️Ethical Standards: Assurance that we prioritize the rights, safety, and welfare of all trial participants. ✔️Transparency and Communication: Clear insights into inspection findings and our commitment to corrective actions. We believe that these practices not only reinforce our commitment to excellence but also provide our clients with the trust and confidence needed in their clinical trials. Speak with a drug development expert for your next project today: 🔗: https://hubs.li/Q02BTTXh0 Read the full guidance here: https://hubs.li/Q02BV7Br0 . . . #clinicalresearch #clinicalstudies #clinicaltrials #phase1 #cro #clinicaltrials #LifeSciences

Ultragenic participated in the Oracle Safety Innovation Summit in Reston, North America, on 8-9 February 2024.   Subject Matter Experts from Oracle discussed the latest innovations in safety, trends in regulations, and features and future of Safety One Argus platform. Our team was there to establish valuable connections and to delve into the newest developments in Argus safety.   #Oracle #OracleLifeSciences #Ultragenic #Innovation #Healthcare #LifeSciences #Pharmacovigilance #PV #Healthcare #Pharma #DrugSafety #PVTechServices #SaaSSafety #DigitalTransformation #TechnologyPartners #Innovation #UltragenicGlobal #ExpertInsights

✳ DIA 2025 - Call for Abstracts Has Been Extended!✳ Here is your chance to be part of the conversation in Washington, DC. (June 15-19, 2025) Our Track Chairs have highlighted priority topics within their educational tracks to provide direction on the content they would like to receive via the Call for Abstracts. You can submit abstracts addressing priority topics and/or topics relevant to the DIA 2025 track descriptions. For more information, or to submit, please visit: https://ow.ly/S3yL50TmjVw Questions? Contact DIA at AnnualMeetingProgram@DIAglobal.org #DIA2025 #callforabstracts #clinicalsafety #pharmacovigilance #clinicaltrials#clinicaloperations #Data #AI#medicalaffairs #PersonalizedMedicine #CombinationProducts#diagnostics #Regulatory #RegulatoryCMC #statistics#datascience #professionaldevelopment

NEWS: Truveta now offers regulatory and audit capabilities to support our customers in real-world evidence submissions to the FDA and other global regulatory authorities. Because of how clearly RWE demonstrates real-life clinical performance, we've invested in establishing: ✅rigorous standards of data quality and provenance, 📃workflow support for regulatory submissions, and 🔎audit-ready processes and controls to support life science orgs in meeting the most stringent regulatory requirements. Learn more: https://tr.vet/3Rx4qiG #RWE #RealWorldEvidence #RegulatoryGrade #RegulatorySubmission #FDA #FoodAndDrugAdministration #DataQuality #RealWorldData #RWD #HEOR #ClinicalTrials #LifeSciences #RegGrade

🌟 Unlock the Power of Integrated Evidence Plans (IEPs)! 🌟 👉Are you curious about leveraging integrated evidence plans (IEPs) effectively? 🌟Want to know how statisticians meet diverse stakeholder needs and ensure the right data is available at the right time? In this second part of our series on IEPs, Jenny Devenport returns to discuss practical applications and timing. Last time, we covered the foundations and significance of IEPs. 📈Today, we dive into specifics: Key Points: 🎯Practical applications and timing of IEPs 🎯Meeting diverse evidence needs 🎯Customizing data for different stakeholders 🎯Minimizing duplication for efficiency 🎯Strategies for regulatory and medical affairs 🎯Enhancing market access 🎯Bridging knowledge gaps 🎯Data-driven decision-making 🎯Supporting product success throughout its lifecycle 🤝Join us as we bridge knowledge gaps, make informed decisions, and drive product success. Statisticians play a crucial role in ensuring pharmaceutical products succeed throughout their lifecycles. 📢Listen now and elevate your understanding of IEPs - https://bit.ly/3LunMBn #IntegratedEvidencePlans #PharmaceuticalStrategies #MedicalAffairs #RegulatoryAffairs #MarketAccess #StatisticiansRole #ProductLifecycle #DataDrivenDecisions