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Therapeutic Goods Administration Update: Medical devices and products like personal medical alarms could be affected by mobile network operators switching off 3G. From 28 October 2024, Telstra and Optus are switching off their third-generation networks. All providers have released information to help people update their phones and plans. Seek help from your supplier or place of purchase if you think your device might use 3G. You may need to replace your device. Read more: https://lnkd.in/g3n5A7-8

The U.S. Food and Drug Administration is accepting drug companies’ proposals to participate in the fiscal year 2025 site visitation program: https://lnkd.in/ghFPE2uC In this program, FDA staff observe operations of commercial manufacturing, pilot plants, and testing operations to gain a better understanding of the pharmaceutical industry and its operations, as well as the challenges impacting a drug’s developmental program and commercial life cycle. FDA encourages companies engaging in the development and manufacturing of both active pharmaceutical ingredients (small and large molecules) and drug products to participate. The agency will select facilities based on priorities for FDA staff training, a facility’s current compliance status with FDA, and other considerations. This program does not supplement or replace a regulatory inspection. Starting October 1, companies interested in offering a site visit or learning more about this program should submit a proposal to CDEROPQSiteVisits@fda.hhs.gov.

📢 Exciting Update: Ethiopia Releases 3rd Version of Good Clinical Practice (GCP) Guidelines! The Ethiopian Food and Drug Authority (EFDA) has published the 3rd version of its Good Clinical Practice (GCP) Guidelines. This updated version offers comprehensive guidance on the ethical and scientific standards for conducting clinical trials in Ethiopia. It ensures that participants’ safety, rights, and well-being are always prioritized. #ClinicalResearch #GCP #Pharmaceuticals #Ethiopia #VizenLifeSciences #EFDA #GoodClinicalPractice

Vizen Life Sciences expresses our deepest condolences to the family members of Mr. Ratan Tata, as well as his countless admirers across the globe. His passing is an irreplaceable loss to India and the world. Mr. Tata's visionary leadership, unwavering dedication to ethical business practices, and immense contributions to societal well-being will forever remain an inspiration. As a beacon of philanthropy and industrial innovation, his legacy extends far beyond the boardroom—he leaves behind a better world for future generations. Our thoughts and prayers are with his loved ones during this difficult time. May his soul rest in peace. #RIPRatanTata #InMemoriam #TataLegacy #Philanthropy #VisionaryLeader

📣 Medicines and Healthcare products Regulatory Agency is asking patients to report, without delay, any safety problem with their continuous glucose monitor or insulin pump. Over 5.6 million people in the UK live with diabetes, many of whom rely on these devices to manage their condition, and their use can significantly improve the quality of life for patients. However, adverse incidents relating to these devices can occur. While most of these incidents do not result in harm to the patient, they can potentially lead to the incorrect amount of insulin being administered which can lead to abnormal blood sugar levels, with potentially serious health consequences. 💡 MHRA has introduced a new step-by-step guidance, giving individuals living with diabetes detailed information on how to report any safety concerns with their device and what information they need to include. This guidance provides examples of the types of issues which should be flagged and images to help guide users in their reporting. To learn more and to review the guidance, visit ➡️ https://bit.ly/3BzZKn3

Innovative PV Comic "Detective RRR Stars in Endgame of Side Effects" Makes Debut at 4th National Pharmacovigilance Week 2024: A groundbreaking comic book titled "Detective RRR Stars in Endgame of Side Effects" has made its highly anticipated debut during the 4th National Pharmacovigilance Week 2024. This innovative publication is designed to raise awareness about the critical role of pharmacovigilance—the process of monitoring and ensuring drug safety. The story follows the beloved detective character, RRR, as he unravels a mysterious series of adverse drug reactions. Through his thrilling investigation, readers are educated about the potential side effects of medications and the importance of reporting these incidents to health authorities. With its creative blend of storytelling and educational content, the comic presents pharmacovigilance in an engaging and accessible format for audiences of all ages. By featuring a popular and familiar character, the creators aim to ignite curiosity and inspire individuals to be more informed about drug safety and reporting adverse reactions. Read More: https://lnkd.in/d22v8xak #DetectiveRRR #Pharmacovigilance #ADR_Reporting #PatientSafety #Vizenlifesciences

🌍 International Plasma Awareness Week (IPAW) ! 🩸 At Vizen Life Sciences, we recognize the critical role that plasma donation plays in saving lives. Plasma is used in the treatment of rare and chronic diseases, including immune deficiencies, bleeding disorders, and many other serious conditions. This week, we join the global community in raising awareness about the importance of donating plasma. Your contribution can provide life-changing therapies and give hope to patients around the world. We encourage everyone to learn more about plasma donation and the difference it can make. Together, let's continue to make a positive impact on global health. 🌟 #PlasmaAwareness #DonatePlasma #IPAW2024 #HealthcareMatters #VizenLifeSciences

📣 Medicines and Healthcare products Regulatory Agency is hosting a joint webinar with the Health Research Authority (HRA) to introduce plans to share a draft guidance with stakeholders and to set out the anticipated timelines for implementing the new UK Clinical Trials regulations. 📅 15 October at 2pm – 4pm (register by 5pm on 10 October) 💻 Online, register ➡️ https://bit.ly/3zTyf7h If you sponsor clinical trials or are an interested stakeholder from academia or the pharmaceutical industry and want to find out more about our approach to implementing the regulations, we encourage you to join this webinar There will be a Q&A for questions on this guidance.

#HSA, Singapore: Guidance for Industry_Post-marketing Vigilance Requirements for Therapeutic Products and CTGTP (Oct. 2024) Summary of changes: - Updated submission processes for new safety information, updated reference #RMP and #RMP documents - Added new requirement on the provision of the 5-year submission schedule for #PBRER - Added required text for finalised artwork of all HSA-approved educational materials - Updated submission processes for post-registration #RMP obligations Read more @ https://lnkd.in/diSwB8Bn

Join the Scientific Symposium on Advanced Therapy Medicinal Products ( #ATMPs) on 10 October 2024, held at EMA’s headquarters of EMA in Amsterdam or online. The event will highlight how ATMPs are revolutionizing patient care, featuring discussions on regulatory advancements and groundbreaking treatments for unmet medical needs. It will also outline the evolution of #EMA’s Committee for Advanced Therapies, the CAT, and its adaptation to the challenges posed by novel classes of ATMPs. 🌟 Don't miss insights from top experts and thought leaders! Register Now! https://lnkd.in/duiKMaEs 📅 Date: 10 October 2024 📍 Location: Amsterdam / Remote