Truveta’s Post

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

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

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

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

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

FDA issued a draft guidance for industry, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities, replacing the guidance issued during the COVID-19 pandemic entitled, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency. FDA often utilized voluntary remote interactive evaluations during the COVID-19 pandemic. After their successful use, FDA is issuing the draft guidance to inform industry about the agency’s continued use of such remote evaluations as an approach for evaluating drug facilities, as appropriate. FDA conducts inspections of drug facilities for many purposes and programs, and we will consider each of those inspection program areas as possible candidates for a remote interactive evaluation. This policy applies to all drug inspection programs including, but not limited to: Preapproval inspections and prelicense inspections, Postapproval inspections, Surveillance inspections, Follow-up and compliance inspections, and Bioresearch monitoring inspections #regulatoryaffairs #regulatory #usfda #fda #regulatorycompalince #regulatoryapproval #drugs

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

FDA finalizes two real-world data guidances for industry Today, FDA issued two final guidances in support of its Real-World Evidence (RWE) Program. Real-World Data: Assessing Registries to Support Regulatory Decision-Making for Drug and Biological Products provides sponsors and other stakeholders with considerations when either designing a registry or proposing to use an existing registry to support a regulatory decision about a drug’s effectiveness or safety. Data Standards for Drug and Biological Product Submissions Containing Real-World Data provides recommendations to sponsors for complying with section 745A(a) of the FD&C Act (21 U.S.C. 379k-1(a)) when submitting study data derived from real-world data (RWD) sources in applicable drug submissions using standards specified in the Data Standards Catalog. The RWE Program focuses on clinical studies that use RWD sources, such as information from routine clinical practice, to generate RWE.  FDA issued both guidances’ draft versions in the fall of 2021 and considered public comments when finalizing the documents. Please read the guidances for more information. #rwe #rwd #dataanalytics #patientdata

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

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.