The Central Drugs Standard Control Organization (CDSCO) has recently published Version 2.0 of its guidelines for the industry on pharmacovigilance requirements for human vaccines. This updated version reflects the latest advancements and regulatory expectations, emphasizing the need for robust safety monitoring throughout the vaccine lifecycle. The guidelines provide a comprehensive framework for the collection, assessment, and reporting of adverse events, ensuring that vaccine safety remains a top priority. This update is a significant step toward enhancing public health and maintaining the highest standards of vaccine safety in India. #CDSCO #Safety #Guidlines #Humanvaccine #MAH .
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Since becoming a member of the WHO PIDM in 1992, South Africa's #pharmacovigilance system has made leaps and bounds. Today, they have a decentralised system which has grown to accommodate disease-specific programmes and immunisation programmes that are also required to report to SAHPRA, the medicines regulatory authority. Read how the implementation of #VigiFlow, a fully ICH-compliant national safety surveillance system, keeps the wheels of pharmacovigilance turning in #UppsalaReports 👉 ow.ly/baWN50TmPB0
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🎥 Under-reporting of adverse drug reactions is a worldwide issue. In 2019, the Botswana Medicines Regulatory Authority set out to improve ADR reporting rates and transform its systems for monitoring the safety of medicines and vaccines. UMC and the World Health Organization and are key partners in their journey, supporting through specialised training and the development and implementation of #pharmacovigilance tools. Watch our latest film in 'The WHO PIDM in Focus' series to learn how #VigiFlow, #VigiMobile, and training and capacity-building are strengthening pharmacovigilance in Botswana🇧🇼 and delivering global impact👇 Explore the rest of the film series here 👉 ow.ly/j81o50QPVtJ
The WHO PIDM in Focus – Botswana
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🎥 In 2019, the Botswana Medicines Regulatory Authority set out to improve adverse drug reaction reporting rates and transform its systems for monitoring the safety of medicines and vaccines. The World Health Organization and UMC are vital partners in their journey, supporting them through specialised training and the development and implementation of #pharmacovigilance tools into their standardised operational procedures. Learn how #VigiFlow, #VigiMobile, and training and capacity-building are strengthening pharmacovigilance in Botswana🇧🇼 and delivering global impact in the film below👇 Discover how members of the WHO PIDM have applied the tools and services in the VIGIVERSE 🪐 in #UppsalaReports 👉 ow.ly/FxQB50TKLj8
The WHO PIDM in Focus – Botswana
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Notice: Call for Feedback on Revised Pharmacovigilance Guidance for Human Vaccines. The Central Drugs Standard Control Organization (CDSCO) has released a draft revision of the “Guidance for industry on Pharmacovigilance requirements for Human Vaccines” (Version 2.0). This update, developed in collaboration with the AEFI Secretariat and IPC-PVPI, aligns with the New Drugs and Clinical Trials Rules, 2019. The CDSCO has developed comprehensive guidance for stakeholders, including Marketing Authorization Holders (MAHs), to coordinate activities across various departments within the Ministry of Health & Family Welfare. This collaboration aims to enhance the pharmacovigilance of vaccines and ensure patient safety. CDSCO invites stakeholders to submit their suggestions, comments, or objections regarding this draft. Submissions should include valid justifications and be sent via email to psur.drugs@cdsco.nic.in within 15 days from the notice date. Feedback received within this period will be considered for the final version of the document. To know more: https://lnkd.in/g5eSKcNg #cliniexperts #Pharmacovigilance #HumanVaccines #DrugSafety #Healthcare #PatientSafety #RegulatoryGuidance #NewDrugsRules #PublicHealth #FeedbackRequest #Regulatoryupdates #updates #DGHS #GOI #CDSCO #MOHWF
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🎥 Without patients, the #pharmacovigilance equation would not be complete. Shanthi Pal, Team Lead of Pharmacovigilance at World Health Organization, describes how #PatientSafety is at the heart of the WHO Programme for International Drug Monitoring (PIDM). Patient narratives help paint the complete picture of adverse events from medicines and vaccines, providing insight into previously unknown side effects, new knowledge to mitigate risks, and impacts on quality of life. Discover how we have built a global PV community and helped to strengthen vaccine surveillance systems together with WHO and programme members in our film series 'The WHO PIDM in Focus' 👉 ow.ly/j81o50QPVtJ
Patient safety in the WHO PIDM
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Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine/vaccine related problem. All medicines and vaccines undergo rigorous testing for safety and efficacy through clinical trials before they are authorized for use. Recently, it's the process and science of monitoring the safety of medicines and taking action to reduce the risks and increase the benefits of medicines. It is a key public health function. #pharmacy #pharmacists #hospitalpharmacy #EPVC #EDA #drugs #health #quality #safety #adverseevents #druginteractions
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Adverse drug reactions (ADRs) are a major cause of morbidity and mortality worldwide. However, underreporting ADRs poses a significant challenge to pharmacovigilance efforts. It's crucial for healthcare professionals to report ADRs, as an effective reporting system of ADRs can greatly improve patient care and safety. Spontaneous ADR reporting is a key method for monitoring drug safety and is essential for post-marketing surveillance. Let's commit to better reporting practices and work together to ensure safer treatments for everyone. Our medical team at Pharmacovigilance Centre of University of Kelaniya will analyze the collated reports and provide report to NMRA, local and global WHO collaborative centres. You shall report the adverse events through the following channels, 1. Website- https://lnkd.in/e3rui7ih 2. WhatsApp- +94 77 755 5564 3. Landline- +94 11 429 4459 4. Email - grpsg211@kln.ac.lk Thank You and please contact us back for any feedback. #Pharmacovigilance #medicine #sideeffects #SriLanka #MedicineSafety
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World Health Organization's Programme for International Drug Monitoring (PIDM) aims to build a robust global community by establishing standards and best practices for #pharmacovigilance implementation. The community fosters collaboration and knowledge-sharing among various stakeholders, including regulatory agencies, pharmaceutical companies, healthcare professionals, and patients. With this initiative, the countries can strengthen their pharmacovigilance infrastructure, improve #drugsafety monitoring, and ultimately enhance public health outcomes worldwide. World Drug Safety Congress Americas #pharma #postmarketsurveillance #patientsafety
The safety of patients worldwide requires a global network dedicated to monitoring the potential risks of medicines and vaccines. Since 1968, the World Health Organization Programme for International Monitoring (PIDM) has brought members together to collaborate nationally and internationally to reinforce regulatory systems and place patients at the heart of #pharmacovigilance and global #healthcare. Our role in education and training, developing PV tools, and as the custodian of VigiBase – the WHO global database of suspected adverse event reports – is integral to the WHO PIDM. See how we've built an international pharmacovigilance community together with members of the WHO PIDM and WHO in a new film 🎥
The WHO PIDM - Building a global community
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🎥 To develop mature #pharmacovigilance systems, members of the World Health Organization Programme for International Drug Monitoring (PIDM) need the skills and training to equip the PV experts of the future. Pinelopi Lundquist, Head of WHO Liaison at UMC, explains how our diverse education and training programmes help members enhance their signal detection capabilities and technical know-how to strengthen the monitoring of medicines and vaccines worldwide. Learn how we have built a global community with WHO and programme members that places patients at the heart of pharmacovigilance and #VaccineSafety surveillance systems in 'The WHO PIDM in Focus' film series 👉 ow.ly/j81o50QPVtJ
Education and training in the WHO PIDM
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The World Health Organization (#WHO) approved the designation of 33 national and regional regulatory authorities as WHO Listed Authorities (#WLAs) that can be relied on for fulfilling the highest level of #regulatory standards and practices for quality, safety, and efficacy of medicines and vaccines. Read more here: https://lnkd.in/eSYaPkEZ
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