Truveta offers regulatory and audit capabilities to support customers in real-world evidence submissions to the FDA and other global regulatory authorities. RWE can clearly demonstrate real-life clinical performance, so 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
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The FDA has published a final guidance document titled "Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products" as part of its real-world evidence (RWE) Program. (https://lnkd.in/gNXUyVbn) The guidance focuses on non-interventional studies using real-world data, which are not clinical investigations under regulations and do not require an IND under 21 C.F.R. § 312. The guidance provides recommendations for sponsors to use RWE from such studies for regulatory decision-making, including ensuring that the FDA has necessary access to the RWD, ensuring that patient-level data is submitted for any clinical study included in a marketing application, and addressing postmarketing safety reporting obligations. The guidance also discusses study monitoring and oversight responsibilities, such as ensuring adequate study records and that the study is conducted in accordance with the final protocol and SAP. It also applies to any type of RWD, including data on products used in clinical practice under an emergency use authorization (EUA). The FDA has typically only discussed the use of RWE to support approval of a new indication for an already approved drug or to help support post-approval study requirements. However, the inclusion of products authorized under an EUA would appear to mean FDA is willing to accept RWE to support initial approval of products, because such products are not "approved." #fda #fdacompliance #RWE #RWD #realworldevidence #regulatoryaffairs #regulatorysubmissions
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I had the pleasure of attending a highly informative and valuable conference focusing on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post-pandemic world, organized jointly by FDA, MHRA and Health Canada. The sessions provided insightful updates on ICH E6(r3) and regulatory perspectives, offering practical trial design and conduct approaches. Discussions on regulatory inspections and bioequivalence studies were particularly enlightening, clarifying common challenges and updates on guidance activities. Moreover, the sessions dedicated to key pharmacovigilance compliance topics offered invaluable insights into ongoing collaborative efforts among international regulatory agencies. Throughout the event, valuable insights into novel operational approaches, data sources, and technologies used in clinical trials were gained. Overall, the conference was an enriching experience. #ClinicalTrials #Pharmacovigilance #Bioequivalence #ICH #RegulatoryUpdates #FDA #HealthCanada #MHRA
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The day has come! The Joint #US- FDA | Medicines and Healthcare products Regulatory Agency - #UK | Health Canada | Santé Canada Good Clinical Practice & Pharmacovigilance Symposium is about to start! Link to the event: https://lnkd.in/e7n8mR_4 Day 1: Tue, Feb 13 8:30 AM - 3:35 PM ET (14:30 pm CET-21:30 pm CET) Day 2: Wed, Feb 14 8:30 AM - 3:50 PM ET (14:30 pm CET-21:30 pm CET) Day 3: Thu, Feb 15 8:30 AM - 4:50 PM ET (14:30 pm CET-22:30 pm CET) The 3-day event at ''the Hotel at the University of Maryland'' will focus on Global #ClinicalTrials in #GoodClinicalPractice, #Bioequivalence, and #Pharmacovigilance in the #postpandemic world. Presentations and panel discussions will provide information on the recent updates made to #ICHE6(r3) and regulatory perspectives on implementation of proportionate and risk-based approaches to the #clinicaltrialdesign and conduct. Panelists will discuss continuing developments in novel operational approaches, #datasources, and technologies used in clinicals trials, as well as novel approaches to regulatory inspections. No time to fit this in your agenda? No problem. Evnia's team of experts will not only be attending but are also available to update you on the latest regulatory advances in #clinicalresearch and help you develop a compliant, pragmatic #clinicaldevelopment strategy! Reach out for more information. #pharma #medtech #biotech
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Associate Head of Practice (GCP US, GMP, CSV, GLP) | Quality Assurance Consulting | Lead Auditor Nonclinical/Clinical Laboratories
This joint workshop will focus on Global Clinical Trials in Good Clinical Practice, Bioequivalence, and Pharmacovigilance in the post pandemic world. Panelists will discuss continuing developments in novel operational approaches, data sources, and technologies used in clinicals trials, and novel approaches to regulatory inspections. Regulators will provide their perspectives on common issues and challenges, and the audience will have the opportunity to hear first-hand from regulators about regulatory updates and ongoing collaborative efforts among the international regulatory agencies. #fda #mhra #healthcanada #regulatorycompliance #gcp #pharmacovigilance #bioequivalence
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Phar
fda.gov
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Aspiring Pharmaceutical Technologist || B.Pharm || Six Sigma White Belt || CRM ||Good Clinical Practices(GCP) || Campus Ambassadors || Aspire Leader by Harvard Business School || AI || Digital marketing ||
Excited to receive my certificate from, ''A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Workshop'' The workshop is organized by SBIA, a collaboration between regulatory bodies including the US FDA, MHRA-UK, and Health Canada. It focuses on global clinical trials, good clinical practice, bioequivalence, and pharmacovigilance in the post-pandemic world. Key updates to ICH E6(R3) are discussed, along with the use of technology in clinical trials, updates for trials incorporating decentralized clinical trial (DCT) features, and changes in clinical trial activities, inspections, and remote regulatory assessments/inspections. Panel discussions cover operational approaches, data sources, technologies, and novel regulatory inspection approaches. #usfda #mhra #goodclinicalpractice #pharmacovigilance #pharma #pharmacist #healthcare #ich #clinicaltrials #clinicalresearch #continuousimprovement
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For #medicaldevice manufacturers in the #US. 🇺🇸 The US Food and Drug Administration FDA has updated its guidance on utilizing real-world data #RWD to generate real-world evidence #RWE for #regulatory purposes. The draft guidance expands on the 2017 guidance, offering new examples of RWD collection, criteria for determining data fitness, and scenarios for regulating specific diagnostic tests. This update, prompted by the 2022 Food and Drug Omnibus Reform Act and the Medical Device User Fee Amendment, addresses the use of RWE not only in Humanitarian Device Exemption, Premarket Approval Application, and De Novo submissions but also in Clinical Laboratory Improvement Amendments (CLIA) determinations. The guidance also addresses the use of clinical data from devices authorized under Emergency Use Authorization and outlines information applicable to CLIA determinations. The FDA acknowledges that both the agency and industry may require up to 60 days to implement the recommendations once the final guidance is released. Until finalized, the 2017 guidance remains in effect, and the draft aims to provide enhanced recommendations to industry and FDA staff, ensuring clarity on RWD's fitness for premarket regulatory purposes. Contact us for qualified support in ensuring compliance to the #FDA regulatory requirements and if you need support around your clinical study design, benchmarking it or do the statistic for its evaluation?☞ meetus@taoexcellence.ch #RealWorldEvidence #RWE #PublicConsultation #RegulatoryDecisionMaking #HealthcareInnovation #publichealth #FDA #regulatoryaffairs #regulatorycompliance #clinicaldata #clinicalevidence #technology #dataanalytics #medicaldevice
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✨Ensure Regulatory Success with Our NEW Guide to ISS & ISE✨ Due to the unique nature of each submission, understanding the best way to plan your Integrated Summaries of Safety & Effectiveness (ISS & ISE) can be difficult. Challenges arise when combining multiple studies to review the safety and efficacy of an IND/NDA. Standardization across data is mandatory as regulatory bodies seek CDISC standards within your submission. Our new in-depth blog provides a deep dive into: 📄 What ISS & ISE are and why they matter 📚 Why Common Technical Documents (CTD) are important 📝 How to create powerful, compliant summaries ✅ The best approach for reviewing integrated summaries 🔍 Common challenges and best practices for success Click the link below to learn more and ensure a successful regulatory submission when drawing conclusions from multiple studies.⬇️ https://hubs.li/Q02s3_9H0 #Quanticate #ISSISE #ClinicalStudies #BioTech #BiometricCRO #RegulatorySubmissions #ClinicalTrials
A Guide to Integrated Summaries of Safety & Effectiveness (ISS & ISE)
quanticate.com
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Data submissions are highly regulated, and every #drug and drug development are different. To present #data in the Common Technical Document, #statisticians must consider appropriate data integration and pooling. Florence Le Maulf discusses presenting #clinical data for #regulatory submission from a stats perspective. Click to learn more 👉 https://bit.ly/455UeSO #CDISC #regulatoryaffairs #FDA #statistics
Presenting Clinical Data for Regulatory Submission: A Stats Perspective
cytel.com
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A Review of How Real-World Evidence Enhances Regulatory Submissions Read the article from Jaclyn Bosco and Marni Hall here - https://lnkd.in/gtvfXm9A #RealWorldEvidence #RWE #RegulatoryDecisions #ClinicalTrials #DrugDevelopment #FDAGuidance #EMA #PharmaceuticalOutsourcing
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Regulatory Affairs | SME | CMC | Compliance Advocate | In & Out-Licensing | CMO | Biosimilars | Medical Devices | Pharmaceuticals | OTC Drugs | Cosmetics | Supplements | Adjunct Faculty | Public Speaker |16+K Followers
Software as a Medical Device (SAMD): Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. The words require or requirements used in this document do not reflect FDA regulatory requirements and are intended only to be considerations for Industry and FDA staff. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
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Chief Executive Officer at USA and International Research Inc.
3wTruveta's commitment to enhancing real-world evidence through rigorous standards and regulatory support is crucial for advancing healthcare innovation. Excited to learn more about your capabilities in this space!