Clinical trials are becoming more complex, with sites spread further across multiple regions, placing a higher burden on Sponsors for pharmacovigilance regulatory compliance. If you are an early-stage drug development Sponsor or work with one, please attend today's webinar or request a copy of the recording to explore what constitutes a compliant pharmacovigilance program, learn of considerations as the new therapy progresses through key milestones, and understand the proper requirements to make informed decisions. It starts at 11AM EST! Last minute registration is still available here: https://hubs.li/Q02G9frG0 #OneMMS #DrugDevelopment #PV #Pharmacovigilance #DrugSafety #Pharmaceuticals
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In a recent webinar on PV audit and inspection, I got the opportunity to present the topic 'PV Audit and Inspection: A Pharmacovigilance Physician Perspective.' In today's pharmaceutical landscape, ensuring the highest standards of Pharmacovigilance plays a vital role in safeguarding patient safety. My talk aimed to shed light on the physician's viewpoint in this process, and sharing my day to day effort towards process and quality improvement. Thank you to all who attended, and let's continue our commitment to enhancing drug safety together. I would like to thank Dr. Chinmaya Mahapatra Oriane Bismuth for making me a part of this scientific webinar. #Pharmacovigilance #DrugSafety #PVInspection #Healthcare #LinkedIn
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Check out our Pharmacovigilance offerings and let me know if you would like to discuss further #pharmacovigilance #clinicaltrials #postmarket
Our pharmacovigilance team supports the safety of our clients’ therapies throughout the clinical development and regulatory approval process— and their life on the market. Learn more 👇 https://bit.ly/3wQByKA #pharmacovigilance #ClinicalDevelopment #RegulatoryApproval
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Regulatory Intelligence 101: Navigating the Labyrinth of Drug Regulations in the USA For anyone involved in the pharmaceutical industry in the United States, Regulatory Intelligence serves as the compass through the intricate landscape of drug regulations. From FDA guidelines to compliance standards, staying informed is the key to navigating the regulatory labyrinth successfully. Join us at booth 101 to gain insights into latest regulatory updates – a fundamental aspect of drug development and commercialization. Discover how a comprehensive understanding of regulatory requirements can not only ensure compliance but also streamline the pathway to bringing safe and effective medications to the public. GRIP is one-of-a-kind subscription service consisting of a comprehensive collection, 160 countries and counting, of global requirements, that have been collected and analyzed by our pharmacovigilance experts. When GRIP is used within Insife’s PROHALO system, the intelligence gathered is linked automatically to other modules and the new rules, once verified and accepted by each GRIP member organization, can automate the submission process. #thedrugsafetyexperts #DIA #conference #PV #riskstrategy #pharmacovigilance #pharma #clinicalsafety #regulatoryintelligence
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From Pharmacy to Pharmacovigilance The world of pharmaceuticals has undergone a dramatic evolution over the past century. This transformation is marked by significant advancements in drug discovery, development, and distribution. However, alongside these advancements comes an increased responsibility to ensure drug safety. This is where the field of pharmacovigilance (PV) comes into play. Transitioning from traditional pharmacy roles to pharmacovigilance is becoming increasingly common, as professionals seek to engage more deeply with the safety and efficacy of medications. This blog explores this journey from pharmacy to pharmacovigilance, highlighting the importance, challenges, and future prospects of this vital domain. Read the complete post at https://lnkd.in/gRQFE67v #pharmacovigilance #argussafety #drugsafety #signaldetection
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General Manager - Life Sciences @ Terrapinn Americas | Drug Safety & Pharmacovigilance | Orphan Drugs | AMR | Disease Prevention | Future Labs Live
Starting from January 16, FDA began accepting electronic submissions of both expedited and non-expedited #postmarketing individual case #safety reports (ICSRs) for human drugs and biological products. Check out below report for more details. World Drug Safety Congress Americas #adverseevents #pharmacovigilance #icsr
FDA Adverse Events Reporting System
fda.gov
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Account Development Specialist II - Connecting with Biopharmaceutical Sponsors to support Clinical Advancement and Regulatory Approval
From clinical development to regulatory approval and beyond, my pharmacovigilance colleagues at Veristat are dedicated to safeguarding the safety of our clients' therapies. Discover how Veristat can support your product's journey to and into the market > https://lnkd.in/gSrumpq9 Wanna know more? Reach out! #pharmacovigilance #ClinicalTrials #Veristat
Veristat | Pharmacovigilance and Medical Information Services
veristat.com
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We are glad to announce our key speaker Satish Sethi, Head Global PV Operations & SERM Surveillance Operations, Glenmark Pharmaceuticals for 33rd Pharmacovigilance 2023 https://lnkd.in/gw-6NhDh For our upcoming conferences visit : https://lnkd.in/gDZD48mZ Fen Castro #VIphv #pharmacovigilance #drugsafety #drugdevelopment #ClinicalSafety #patientsafety #RiskManagement #clinicaltrials #mumbai #clinicalresearch #Qualitycontrol #clinicaltrials #clinicalresearch #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #pharmanews #regulatory #medicinesaffairs #pharmaceuticalindustry #pharmaceuticals #biosimilars #biotech #healthcareleaders #drugs #medicines #patient #vigilance #clinicaldevelopment #pv #healthtech
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Accomplished approvals & commercialization of 26 Drugs & 6 Medical Devices across US, UK & EU | Elevated Clinical trial outcomes | Faster Regulatory clearance | Enhanced Safety & Risk-Benefit Balance |Timely Market Entry
- Missed reporting of an Fatal/Serious ICSR case🙄 - Cases reported late to regulatory authority🤔 - Case never appeared in the workflow😒 - Case was routed to next stage by mistake - Case was missed during reconciliation Senior management continues to inquire if anything could be done regarding these challenges? No matter whatever action plans are in place, the same findings keep popping up in most of the GVP audits: Different volumes and workflow has different processes and strategies: Look what have we done? 👇👇 https://lnkd.in/d4Drn4rt #drugsafety #jobs #career #pharmacovigilance #bpharm #mpharm #MBBS #MD #BDS #BAMS #clinicaltrials #drugdevelopment #SDEA #PVAs #pharmaceuticalindustry #clinicalresearch #clinicaldevelopment #regulatoryaffairs #pharmaceuticalcompanies #pharmaindustry #biotech #medicalaffairs #pharma #biopharmaceuticals #vaccines #drugdiscovery #medicaldevice #pharmaceuticalsciences #lifesciences #signaldetection #aggregatereports #riskmanagementplan #RMP #medicine #medical #healthcare #fda #medicaldevices #training #safety #onlinetraining #ICSR #PBRER #DSUR #PSUR #PADER #REMS #opportunities #interview
Drug safety & Pharmacovigilance
https://globalplacosolutions.com
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We are glad to introduce our renowned speaker Bill Haddock, VP, Pharmacovigilance & R&D Quality, Ovid Therapeutics for #Pharmacovigilance USA 2024 https://lnkd.in/gRqDQpZn For our upcoming conferences visit : https://lnkd.in/gDZD48mZ Fen Castro Piyush Patel #VIphv #drugsafety #drugdevelopment #ClinicalSafety #patientsafety #RiskManagement #safetysurveillance #medicinesaffairs #pvusa #clinicaltrials #usa #clinicalresearch #vigilance #clinicaldevelopment #Qualitycontrol #pharma #healthcare #lifesciences #RegulatoryAffairs #RegulatoryWriting #MedicalWriting #scientificwriting #regulatory #pharmaceuticals #biosimilars #biotech #patient
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