Pharmuni’s Post

As the pharmaceutical landscape evolves, ensuring the safety and efficacy of generic drugs remains paramount. Leveraging post-marketing surveillance (PMS) data effectively is key to achieving this goal. From the handful experience of handling various ASRs, I have realized that optimizing the PMS data to author the report is pretty much first necessary step for an organized report. So, here I've jotted down some strategies to optimize PMS data for crafting comprehensive Aggregate Safety Reports, which can be helpful for the ASR authors and as well as the other PV colleagues- 1️⃣ Data Quality Assurance: Start by ensuring the quality and reliability of PMS data through rigorous validation processes. Clean, accurate data forms the foundation for meaningful analysis. 2️⃣ Standardized Data Collection: Implement standardized data collection methodologies across different sources to facilitate seamless integration and analysis. Consistency in data format and terminology is crucial for robust reporting. 3️⃣ Risk Identification: Utilize advanced analytics techniques to identify and prioritize potential safety concerns associated with generic molecules. Early detection allows for proactive risk management strategies. 4️⃣ Signal Detection and Evaluation: Leverage statistical algorithms and data mining tools to detect emerging safety signals within PMS data. Thorough evaluation of these signals helps in distinguishing genuine risks from background noise. 5️⃣ Regulatory Compliance: Stay abreast of evolving regulatory requirements and guidelines for Aggregate Safety Reporting. Ensuring compliance with regulatory standards is essential for maintaining product quality and patient safety. 6️⃣ Cross-functional Collaboration: Foster collaboration between pharmacovigilance, medical affairs, regulatory affairs, and other relevant stakeholders to gain holistic insights into safety data and enhance decision-making processes. By implementing these strategies, the ASR authors can generate robust Aggregate Safety Reports, ultimately contributing to the continuous improvement of patient care and public health. #Pharmacovigilance #DrugSafety #GenericMolecules #PMSData #Healthcare #PatientSafety #pharmacist #healthcare

This week we are holding the Short Course: Introduction to Statistics in Pharmacovigilance (Jan 24) in a virtual format. Lesley Wise is the instructor for this (mainly) formula-free half-day course will provide a basic introduction to statistics and probability which will be applied in the context of drug safety. Grab your colleagues and join us for this fantastic course - https://lnkd.in/ec6U3eGv #pharma #statistics #pharmacovigilance

Truliant Consulting is launching a survey to study how pharmaceutical companies are proceduralizing and oversighting compliance.  The survey is designed to solicit feedback from PV Compliance leads regarding pharmaceutical companies' approach to Compliance regarding people, tools, quality management system and process.   Link to the survey: https://lnkd.in/eVA9ty9E   Completion of this survey should take less than 15 minutes and can be done until COB Friday, the 17th of May.   All data collected as part of this survey will be analysed in a completely anonymous manner.   Results will be summarised in a future edition of PIPELINE.

I'm happy to share that as a student, I attained a webinar on clinical data management! It was an enriching experience decoding the complexities of this field alongside industry experts. From data collection to regulatory compliance, they covered it all, gaining invaluable insights for our future careers. Grateful for the opportunity to connect with peers and professionals in the pharmaceutical community. #ClinicalDataManagement #IPA#Webinar🌟

🌟 Unlock the Power of Integrated Evidence Plans (IEPs)! 🌟 👉Are you curious about leveraging integrated evidence plans (IEPs) effectively? 🌟Want to know how statisticians meet diverse stakeholder needs and ensure the right data is available at the right time? In this second part of our series on IEPs, Jenny Devenport returns to discuss practical applications and timing. Last time, we covered the foundations and significance of IEPs. 📈Today, we dive into specifics: Key Points: 🎯Practical applications and timing of IEPs 🎯Meeting diverse evidence needs 🎯Customizing data for different stakeholders 🎯Minimizing duplication for efficiency 🎯Strategies for regulatory and medical affairs 🎯Enhancing market access 🎯Bridging knowledge gaps 🎯Data-driven decision-making 🎯Supporting product success throughout its lifecycle 🤝Join us as we bridge knowledge gaps, make informed decisions, and drive product success. Statisticians play a crucial role in ensuring pharmaceutical products succeed throughout their lifecycles. 📢Listen now and elevate your understanding of IEPs - https://bit.ly/3LunMBn #IntegratedEvidencePlans #PharmaceuticalStrategies #MedicalAffairs #RegulatoryAffairs #MarketAccess #StatisticiansRole #ProductLifecycle #DataDrivenDecisions

💊 𝗘𝗺𝗽𝗼𝘄𝗲𝗿𝗶𝗻𝗴 𝗗𝗿𝘂𝗴 𝗦𝗮𝗳𝗲𝘁𝘆 𝗧𝗵𝗿𝗼𝘂𝗴𝗵 𝗜𝗻𝗻𝗼𝘃𝗮𝘁𝗶𝘃𝗲 𝗟𝗶𝘁𝗲𝗿𝗮𝘁𝘂𝗿𝗲 𝗠𝗼𝗻𝗶𝘁𝗼𝗿𝗶𝗻𝗴 𝗧𝗲𝗰𝗵𝗻𝗼𝗹𝗼𝗴𝘆 We are calling all #pharmacovigilance professionals! Have you ever felt the strain of manually sorting through mountains 📚 of data to spot adverse events? We hear you, so our latest blog post is a must-read. Dive into the dynamic world of technology-driven drug safety management, where solutions like DrugCards are rewriting the rules of literature monitoring across Europe and CIS countries 🌍. Discover how #DrugCards' state-of-the-art automated approach is streamlining processes and revolutionizing the entire pharmacovigilance landscape 🦾. From improving #medication safety to reducing costs and resource burdens, this innovation is a game-changer you can't overlook. 🔥 Ready to embrace innovation in pharmacovigilance? Join us on this exciting journey! Read the full article here 👉: https://lnkd.in/dRNuRWmz