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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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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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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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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- 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/dKsT5_sr #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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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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Myth: "Pharmacovigilance merely gathers reports of side effects; it doesn't contribute to drug development." Reality: Pharmacovigilance is far more than a data-collection process! While it does involve monitoring and analyzing adverse events, it's also an integral part of the drug development process. By identifying safety concerns early, pharmacovigilance guides decisions throughout a product's life cycle. This proactive approach not only safeguards patient well-being but also enables pharmaceutical companies to create safer and more effective drugs. Let's dispel this myth and acknowledge the invaluable role pharmacovigilance plays in both patient safety and innovative drug development. 🚀💊 Contact us: baupharma.com/contact-us/ #PharmacovigilanceFacts #DrugSafety #InnovationMatters
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MedDRA MSSO plays a crucial role in ensuring accurate adverse event reporting in the pharmaceutical industry. I would like to express my sincere thanks to Dr.Anamika ma'am for this webinar which gives the insight of the MedDRA Coding and knowledge about the drug safety and pharmacovigilance. I would like to express my sincere thanks to Mujeebuddin Shaik sir, Uma Priya ma'am for providing me this opportunity to attend the webinar. #MedDRA #drugsafety #pharmacovigilance #clinicalpharmacist
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#Pharmacovigilance is a crucial part of #clinicalresearch as it ensures the safety and effectiveness of investigational drugs. Innovative technologies such as #AI has a lot of potential to greatly enhance pharmacovigilance practices by transforming drug safety monitoring. Swipe left to learn more. Check out how we can help your trials: https://bit.ly/3V0H5bg #ClinicalTrials #LifeSciences #ArtificialIntelligence #DrugSafety
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