Sikupiso Mukutulu’s Post

🌟 Day 2: Ensuring Regulatory Excellence and Compliance in Pharmacovigilance: Medical Inquiry & Medication Error 🌟 After an outstanding Day One, We are excited to lead today’s session at the AFri Summit on "Ensuring Regulatory Excellence and Compliance in Pharmacovigilance – Medical Inquiry & Medication Error" by Dr. Nahed Yaish. Today’s discussion will focus on a realistic case study, providing practical insights on integrating ARMMs and USR into quality management. We’ll tackle real-world scenarios involving medical inquiries and medication errors, equipping you with actionable tools to strengthen patient safety and regulatory compliance. Don’t miss out on Day Two at the AFri Summit! #AFRISUMMIT2024 #SOPCONSULTANCYCENTER #pharmacovigilance #training #consultation

Good morning, everyone! What an amazing first day we had! The energy and interaction were truly inspiring, and I appreciate everyone who joined and contributed. Today, we're shifting gears to explore regulatory frameworks, compliance strategies, and industry best practices. I'm looking forward to another insightful session, and I'm excited to keep learning and growing together with all of you! #AFRISUMMIT2024 #SOPCONSULTANCYCENTER #pharmacovigilance #training #consultation

𝗡𝗮𝘃𝗶𝗴𝗮𝘁𝗶𝗻𝗴 𝗙𝗗𝗔'𝘀 𝗡𝗲𝘄 𝗜𝗖𝗦𝗥 𝗥𝗲𝗽𝗼𝗿𝘁𝗶𝗻𝗴 𝗥𝗲𝗾𝘂𝗶𝗿𝗲𝗺𝗲𝗻𝘁𝘀: 𝗨𝗹𝘁𝗿𝗮𝗴𝗲𝗻𝗶𝗰 𝗶𝘀 𝗛𝗲𝗿𝗲 𝘁𝗼 𝗛𝗲𝗹𝗽.   The FDA's final regulation on submitting Individual Case Safety Reports (ICSR) in XMLR3 format has set a compliance deadline for March 2026, affecting both pre-market and post-market cases. Shadab Mohammed explains us how as a leader in pharmacovigilance, Ultragenic has been at the forefront of this transition, participating in the FDA pilot program alongside our clients. 𝙇𝙤𝙤𝙠𝙞𝙣𝙜 𝙛𝙤𝙧 𝙖 𝙩𝙧𝙪𝙨𝙩𝙚𝙙 𝙥𝙖𝙧𝙩𝙣𝙚𝙧 𝙩𝙤 𝙚𝙣𝙨𝙪𝙧𝙚 𝙖 𝙨𝙢𝙤𝙤𝙩𝙝 𝙩𝙧𝙖𝙣𝙨𝙞𝙩𝙞𝙤𝙣? 𝘾𝙤𝙣𝙣𝙚𝙘𝙩 𝙬𝙞𝙩𝙝 𝙪𝙨, 𝙖𝙣𝙙 𝙡𝙚𝙩'𝙨 𝙖𝙘𝙝𝙞𝙚𝙫𝙚 𝙘𝙤𝙢𝙥𝙡𝙞𝙖𝙣𝙘𝙚 𝙩𝙤𝙜𝙚𝙩𝙝𝙚𝙧! 🤝   #Ultragenic #AdverseEvents #LifeSciences #Pharmacovigilance #PV #Healthcare #Technology #Automation #Consulting #Safety #Compliance #DrugSafety #PVTechServices #DataMigration #UltraInsights #FDACompliance #ICSR

Regulatory affairs as a field of practice provides the basis for the assurance of #Quality of medicines and medical products which increase consumers' interest by ensuring efficacy, quality, and safety. Recent statistics have shown there is a shortage of skilled and trained #RegulatoryAffairsProfessionals in the market and as a result, regulatory affairs professionals are in demand. To be a participator in enhancing quality health, register for the regulatory affairs training with us: https://lnkd.in/dvTEzVgJ Course Fee: 300USD (Installments are allowed) Registration Deadline: May 03, 2024 #PharmaceuticalWorkforceDevelopment #RegulatoryAffairs

Navigating the New Regulatory Landscape in Pharmacovigilance with Argus Safety At Penteract Solutions, we are committed to staying at the forefront of regulatory changes and ensuring our clients are always compliant with the latest guidelines. As regulatory bodies worldwide continue to evolve their requirements, it's crucial for pharmacovigilance professionals to adapt and implement best practices effectively. Key Regulatory Update: The FDA's recent guidance on the integration of Real-World Data (RWD) from electronic health records (EHRs) emphasizes the need for robust data management and analytics capabilities. This guidance highlights the increasing importance of leveraging RWD to enhance drug safety monitoring and decision-making processes. To align with these regulatory changes, Argus Safety systems need to be enhanced. These enhancements may include: - Automated Data Import: Seamlessly import RWD from EHRs and other sources into Argus Safety. - Enhanced Signal Detection: Utilize advanced algorithms to detect safety signals earlier and more accurately. - Customizable Workflows:Tailor workflows to meet specific regulatory requirements and improve efficiency. At Penteract Solutions, we understand that adapting to new regulations can be challenging, but with the right tools and strategies, it becomes an opportunity for growth and improvement. Let's navigate these changes together and ensure the highest standards of drug safety. #Pharmacovigilance #ArgusSafety #RegulatoryUpdates #DrugSafety #PenteractSolutions #BestPractices #RWD #EHR #Compliance

Are You All Set to Merge Automation and Compliance For a Competitive Edge? Join us on a live webinar on August 29, 2024. Achieve a Strategic Advantage by Automating Compliance. Explore how the latest automation technologies can revolutionize your pharmacovigilance strategy, positioning you as an industry leader." With insights from Riddhi Doshi, PV - SME Head at Sarjen Systems Pvt Ltd, you will learn how automation can unlock new opportunities and streamline your pharmacovigilance efforts. 📆 Date: Thursday, August 29, 2024 🕔 Time: 5:00 PM IST | 1:30 PM CET Don’t just comply - lead the way. Register today and step into the future of pharmacovigilance! Link: https://lnkd.in/gAVf-rqF #Pharmacovigilance #Automation #DrugSafety #Healthcare #Compliance #Innovation #Webinar #PvEdge #CompetitiveEdge #HealthcareTechnology #DigitalTransformation #LifeSciences #RegulatoryAffairs #MedicalTechnology #PatientSafety #PharmaIndustry

📢 Join us for the 𝟮-𝗗𝗮𝘆 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗼𝗻𝗳𝗲𝗿𝗲𝗻𝗰𝗲 🌟 The Future of Drug Safety: Pharmacovigilance in an Evolving World. 🌟 𝙊𝙧𝙜𝙖𝙣𝙞𝙯𝙚𝙙 𝘽𝙮 𝙎𝘾𝙍𝙈𝙋 - 𝙋𝙝𝙖𝙧𝙢𝙖𝙘𝙮 𝙒𝙞𝙣𝙜. Kickstarting with our Esteemed Speaker. 🗓 DATE: 01 December, 2024 🎤 Session by 𝗡𝗼𝘂𝗿𝗮 𝗠𝗮𝗵𝗲𝗿 - Senior Health Economist VICE PRESIDENT, CEC | SCRMP INDUSTRY WING 🕖 TIME: 3 PM - 4 PM (IST) 𝗧𝗼𝗽𝗶𝗰: "Health Technology assessment HTA Concepts." Join us for this insightful session. 💻 𝑷𝒍𝒂𝒕𝒇𝒐𝒓𝒎: 𝑴𝒊𝒄𝒓𝒐𝒔𝒐𝒇𝒕 𝑻𝒆𝒂𝒎𝒔 👉 𝗥𝗲𝗴𝗶𝘀𝘁𝗲𝗿 𝗻𝗼𝘄 𝗯𝘆 𝘀𝗰𝗮𝗻𝗻𝗶𝗻𝗴 𝘁𝗵𝗲 𝗤𝗥 𝗰𝗼𝗱𝗲 𝗼𝗿 𝘃𝗶𝘀𝗶𝘁𝗶𝗻𝗴 𝘁𝗵𝗶𝘀 𝗹𝗶𝗻𝗸: https://lnkd.in/gQmiZDsf 𝐎𝐑𝐀𝐋 𝐏𝐑𝐄𝐒𝐄𝐍𝐓𝐀𝐓𝐈𝐎𝐍𝐒: 📄 𝐀𝐛𝐬𝐭𝐫𝐚𝐜𝐭 𝐛𝐚𝐬𝐞𝐝 𝐨𝐧 𝐭𝐡𝐞 𝐓𝐡𝐞𝐦𝐞 𝐨𝐟 𝐭𝐡𝐞 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞. 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐃𝐞𝐭𝐚𝐢𝐥𝐬: 𝐃𝐞𝐚𝐝𝐥𝐢𝐧𝐞: 𝟐𝟓𝐭𝐡 𝐍𝐨𝐯𝐞𝐦𝐛𝐞𝐫, 𝟮𝟬𝟮𝟰 𝐒𝐮𝐛𝐦𝐢𝐬𝐬𝐢𝐨𝐧 𝐄𝐦𝐚𝐢𝐥: studentforum.scrmp@gmail.com Stay tuned for updates on the full conference agenda and other exciting sessions. #scrmp #Pharmacovigilance #DrugSafety #PharmacyConference #IQVIA #pharmacy #research #pharmd

If you are the #WorldDrugSafety Congress 2024, don't miss out this insightful presentation from Sriram Varma on the approaches to achieve digitalization & automation of global pharmacovigilance operations to optimize quality and compliance. He'll be speaking at Hall C at 3:30 PM EST today. Key Takeaways: * Simplifying operational efficiency through a connected and AI-enabled PVOps digital platform * Establishing oversight of PV processes, vendors and partners through digitally orchestrated safety operations. #WDSC2024 #Pharmacovigilance #Innovation #DigitalTransformation #DrugSafety #TechsolLifeSciences #DrugSafety #Digitalization #Automation

📢 The Importance of Collecting and Reporting Adverse Events in Pharmacovigilance 📢 In pharmacovigilance, every reported adverse event is a step toward safer healthcare. By accurately documenting and analyzing these events, we can identify potential risks, protect patients, and improve treatments. This vigilance is critical not only for patient safety but also for maintaining trust in medical advancements. Adverse event reporting isn't just data collection—it's about safeguarding lives and ensuring that every patient receives effective, safe treatments.  Every adverse event reported improves understanding of a drug's safety/risk profile and helps prevent further incidents. Reporting helps protect patients, informs clinical practice, and guides regulatory decisions. Let’s work together to build a safer future in medicine through active pharmacovigilance. 🌍💊 #Pharmacovigilance #PatientSafety #Healthcare #RegulatoryAffairs #DrugSafety #ClinicalResearch #Careerdevelopment #PharmacovigilanceCareers #PharmaCareers #RegulatoryReporting #MHRA #GoodPharmacovigilancePractices

Navigating the world of pharmacovigilance can be complex, especially when it comes to understanding the regulatory requirements for adverse event reporting. Let’s break down the essentials of CFR Title 21 Part 600 and why it’s crucial for life science professionals. This regulation outlines the standards for reporting adverse events related to biologic products, such as vaccines and blood components, ensuring that safety issues are promptly identified and addressed. Why Is Adverse Event Reporting Important? • Protects Patient Safety: By monitoring and reporting adverse events, healthcare professionals and manufacturers play a critical role in safeguarding public health. • Regulatory Compliance: Adhering to these guidelines is not just a best practice—it’s a legal requirement. Failure to report can result in significant penalties and jeopardize product approval status. Key Reporting Requirements: • Timeliness: Adverse events must be reported within specific timeframes, ranging from 15 days for serious and unexpected events to periodic reports for ongoing safety updates. • Content: Reports must include detailed patient information, event description, and any known contributing factors to provide a comprehensive view for regulatory review. Who Should Be Concerned? • Healthcare Providers: Understanding these requirements ensures that adverse events are promptly and accurately reported, contributing to the overall safety of biologic therapies. • Life Science Professionals: Whether in clinical, regulatory, or safety roles, being well-versed in Part 600 is essential for compliance and maintaining product integrity. #LifeSciences #Pharma #Biotech —————— 🔔 Follow me here on LinkedIn for clear, concise insights into the life sciences. I post three times weekly! 📩 Subscribe to my monthly newsletter for deeper dives into topics important to the medical information space.