Uppsala Monitoring Centre’s Post

🎥 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 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 .

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

VigiMobile is an add on ADR and AEFI reporting platform which we are generally excited to roll out in Botswana. The platform is based on WHO’s standard reporting forms for medicines and vaccines. It will enable Healthcare professionals to report ADRs and AEFIs from wherever they are as opposed to paper-based reporting where we have been receiving reports relatively late. Further, VigiMobile will enable structured reporting which will solve the challenge of converting unstructured information into a format compatible with VigiFlow, speeding up the analysis process. Overall VigiMobile will enable fast and easy reporting of safety reports which will allow BoMRA to conduct data analysis real-time to identify potential safety signals real-time!

🎥 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

🎥 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

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

🚨 Countdown: 3️⃣ Months Until EVDAS Becomes Mandatory for All Marketing Authorization Holders (MAHs) Starting 2025, ALL MAHs will be required to monitor active substances through the EudraVigilance Data Analysis System (EVDAS) for better signal detection and pharmacovigilance compliance. EVDAS, developed by the European Medicines Agency (EMA), is a game-changer for safety monitoring, and although may seem complex, with the right support can become an ally in ensuring patient safety and product improvement. 🔗 Learn more about EVDAS: https://hubs.ly/Q02RtrW60 #Pharmacovigilance #EVDAS #PQEGroup #SignalManagement #Compliance #RegulatorySupport #PatientSafety #EUDRAvigilance

Taiwan – important regulatory changes. The ADR reporting system for the Taiwan Food and Drug Administration (TFDA) has been updated, and there are potentially significant implications with operational compliance for anyone submitting ICSRs, which we have summarised below: ·  The TFDA ADR Notification System has resumed operation from 15/08/2024 ·  Access and file upload is restricted to verified Taiwanese citizens ONLY ·  Reports must be re-entered into the ADR system when full access is granted ·  Acknowledgements must be sent to the TFDA for reconciliation before 30/10/2024 ·  The ADR system will now only allow the upload of individual XML files and not zip files You can find a link to the official TFDA website here - https://lnkd.in/dMeFbcbJ Delta PV has already implemented all the necessary operational changes for our clients without delay or issue. If you are unsure how this may affect the compliance of your products, just reach out to us at info@deltapv.com, we’ll be happy to discuss. For information about our pharmacovigilance solutions here: https://lnkd.in/gjAusNrF And information about LITSIS system here: https://lnkd.in/gDJRDzj6 Please share this post to spread the news and help Delta PV keep growing. Delta PV creates lean, efficient, and effective pharmacovigilance and safety solutions across Europe, CIS, EAEU, Africa, MENA, and APAC. See how we can support you at www.deltapv.com #Pharmacovigilance #ClinicalSafety #PVTechnology 

Taiwan has introduced important regulatory changes to the ADR reporting system, which may affect compliance for those submitting ICSRs. Key updates: TFDA ADR system resumed on 15/08/2024 Access restricted to verified Taiwanese citizens Acknowledgements due by 30/10/2024 Only individual XML file uploads allowed Delta PV has already made the necessary adjustments. If you're unsure how this impacts your compliance, feel free to reach out! #Pharmacovigilance #ClinicalSafety #PVTechnology