Semen Sen Kurt’s Post

Breaking Down the EMA’s Latest Directive on ICSRs - What You Need to Know! The European Medicines Agency (EMA) has implemented significant changes to the reporting process for Individual Case Safety Reports (ICSRs), aimed at harmonizing and streamlining the collection and evaluation of safety data. Since March 2024, the revised guidelines will standardize the start of ‘Day 0’ across electronic and hardcopy submissions, defining it as the date when enough information is available to validate an ICSR. This crucial update removes the ambiguities that previously led to inconsistencies in data handling and reporting timelines. Key Points: • Uniform Start Date: Whether it’s a digital or paper trail, Day 0 is when a report can first be considered complete enough for further processing. • Swift Action Required: Marketing Authorization Holders (MAHs) must now ensure that potential adverse reactions are reported within seven days of this identification point to remain compliant. Impact on Pharmacovigilance Practices: This update underscores the importance of having robust systems and trained personnel in place to swiftly gather and report accurate data. MAHs need to reassess their current processes and technology to adapt to these changes efficiently. Why It Matters: These guidelines aim to enhance patient safety by ensuring quicker and more reliable adverse event reporting, providing regulatory bodies and healthcare providers with timely information to make better-informed decisions. #Pharmacovigilance #DrugSafety #HealthcareRegulation #EMA #RegulatoryAffairs #PatientSafety

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

🌍💊 #MedSafetyWeek 2024 (4-10 November) is here! 💊🌍   At spmd - safety strategies for health, we’re proud to support the #UppsalaMonitoringCentre and other global regulatory bodies to promote Pharmacovigilance (PV) and the crucial act of reporting adverse drug reactions (ADRs).   Why is reporting ADRs so important?   🔹 It provides real-time data that helps identify new risks. 🔹 It ensures the safety of medicines by preventing serious health risks. 🔹 It empowers patients and healthcare professionals to contribute to a safer healthcare system.   "𝘠𝘰𝘶𝘳 𝘪𝘯𝘱𝘶𝘵 𝘮𝘢𝘵𝘵𝘦𝘳𝘴—𝘣𝘺 𝘳𝘦𝘱𝘰𝘳𝘵𝘪𝘯𝘨 𝘴𝘪𝘥𝘦 𝘦𝘧𝘧𝘦𝘤𝘵𝘴, 𝘺𝘰𝘶 𝘩𝘦𝘭𝘱 𝘳𝘦𝘨𝘶𝘭𝘢𝘵𝘰𝘳𝘴 𝘮𝘢𝘬𝘦 𝘪𝘯𝘧𝘰𝘳𝘮𝘦𝘥 𝘥𝘦𝘤𝘪𝘴𝘪𝘰𝘯𝘴 𝘵𝘩𝘢𝘵 𝘴𝘢𝘧𝘦𝘨𝘶𝘢𝘳𝘥 𝘱𝘶𝘣𝘭𝘪𝘤 𝘩𝘦𝘢𝘭𝘵𝘩."   📝 For the USA, the 𝗨.𝗦. 𝗙𝗼𝗼𝗱 𝗮𝗻𝗱 𝗗𝗿𝘂𝗴 𝗔𝗱𝗺𝗶𝗻𝗶𝘀𝘁𝗿𝗮𝘁𝗶𝗼𝗻 (𝗙𝗗𝗔) provided comprehensive information on how you can report side effects directly to health authorities: https://lnkd.in/etHpzD34   As a specialized PV service provider, we assist Sponsors and Marketing Authorization Holders in monitoring and managing the safety profiles of their products from discovery to post-marketing worldwide. This helps ensure that medicinal products continue to be safe for patients across the globe.   Learn more about how we support #PatientSafety and ensure robust pharmacovigilance systems at www.spmd-safety.com. Together, we can enhance the safety of drugs and medicines worldwide!   #MedSafetyWeek2024 #Pharmacovigilance #PatientSafety #SPMD #UppsalaMonitoringCentre #DrugSafety

🎥 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

As we approach the 4th National Pharmacovigilance Week, taking place from 17-23 September 2024, we turn our attention to the pivotal role of Adverse Drug Reaction (ADR) reporting in ensuring patient safety. This year’s theme, Building an ADR Reporting Culture for Patient Safety, underscores the importance of collective responsibility and vigilance in healthcare. By cultivating a strong culture of ADR reporting, we can significantly enhance patient care and safeguard the health of millions. We invite everyone to join this critical effort in strengthening pharmacovigilance practices and improving healthcare outcomes. National Pharmacovigilance Week: 17-23 September 2024 Theme: Building an ADR Reporting Culture for Patient Safety Focus: Strengthening ADR reporting for patient safety Call to Action: Participate to advance pharmacovigilance and help save lives Let’s work together for a safer tomorrow! SOCIAL MEDIA CAMPAIGN SMC: - 01 (Meme) #NPW2024 #Pharmacovigilance #PatientSafety #ADRReporting #PvPI #HealthcareExcellence

As we approach the 4th National Pharmacovigilance Week, taking place from 17-23 September 2024, we turn our attention to the pivotal role of Adverse Drug Reaction (ADR) reporting in ensuring patient safety. This year’s theme, Building an ADR Reporting Culture for Patient Safety, underscores the importance of collective responsibility and vigilance in healthcare. By cultivating a strong culture of ADR reporting, we can significantly enhance patient care and safeguard the health of millions. We invite everyone to join this critical effort in strengthening pharmacovigilance practices and improving healthcare outcomes. National Pharmacovigilance Week: 17-23 September 2024 Theme: Building an ADR Reporting Culture for Patient Safety Focus: Strengthening ADR reporting for patient safety Call to Action: Participate to advance pharmacovigilance and help save lives Let’s work together for a safer tomorrow! SOCIAL MEDIA CAMPAIGN SMC: - 08 (Meme) #NPW2024 #Pharmacovigilance #PatientSafety #ADRReporting #PvPI #HealthcareExcellence

🎥 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

As we approach the 4th National Pharmacovigilance Week, taking place from 17-23 September 2024, we turn our attention to the pivotal role of Adverse Drug Reaction (ADR) reporting in ensuring patient safety. This year’s theme, Building an ADR Reporting Culture for Patient Safety, underscores the importance of collective responsibility and vigilance in healthcare. By cultivating a strong culture of ADR reporting, we can significantly enhance patient care and safeguard the health of millions. We invite everyone to join this critical effort in strengthening pharmacovigilance practices and improving healthcare outcomes. National Pharmacovigilance Week: 17-23 September 2024 Theme: Building an ADR Reporting Culture for Patient Safety Focus: Strengthening ADR reporting for patient safety Call to Action: Participate to advance pharmacovigilance and help save lives Let’s work together for a safer tomorrow! SOCIAL MEDIA CAMPAIGN SMC: - 05 (Meme) #NPW2024 #Pharmacovigilance #PatientSafety #ADRReporting #PvPI #HealthcareExcellence

As we approach the 4th National Pharmacovigilance Week, taking place from 17-23 September 2024, we turn our attention to the pivotal role of Adverse Drug Reaction (ADR) reporting in ensuring patient safety. This year’s theme, Building an ADR Reporting Culture for Patient Safety, underscores the importance of collective responsibility and vigilance in healthcare. By cultivating a strong culture of ADR reporting, we can significantly enhance patient care and safeguard the health of millions. We invite everyone to join this critical effort in strengthening pharmacovigilance practices and improving healthcare outcomes. National Pharmacovigilance Week: 17-23 September 2024 Theme: Building an ADR Reporting Culture for Patient Safety Focus: Strengthening ADR reporting for patient safety Call to Action: Participate to advance pharmacovigilance and help save lives Let’s work together for a safer tomorrow! SOCIAL MEDIA CAMPAIGN SMC: - 16 (Meme) #NPW2024 #Pharmacovigilance #PatientSafety #ADRReporting #PvPI #HealthcareExcellence

As we approach the 4th National Pharmacovigilance Week, taking place from 17-23 September 2024, we turn our attention to the pivotal role of Adverse Drug Reaction (ADR) reporting in ensuring patient safety. This year’s theme, Building an ADR Reporting Culture for Patient Safety, underscores the importance of collective responsibility and vigilance in healthcare. By cultivating a strong culture of ADR reporting, we can significantly enhance patient care and safeguard the health of millions. We invite everyone to join this critical effort in strengthening pharmacovigilance practices and improving healthcare outcomes. National Pharmacovigilance Week: 17-23 September 2024 Theme: Building an ADR Reporting Culture for Patient Safety Focus: Strengthening ADR reporting for patient safety Call to Action: Participate to advance pharmacovigilance and help save lives Let’s work together for a safer tomorrow! SOCIAL MEDIA CAMPAIGN SMC: - 15 (Meme) #NPW2024 #Pharmacovigilance #PatientSafety #ADRReporting #PvPI #HealthcareExcellence