Allison Whitley’s Post

Exciting update for the healthcare and Pharmacovigilance community! 🩺📊 MEDDRA Version 26.1 is here, ushering in new coding possibilities and improved data analysis capabilities. 🚀 Stay current with the latest standards and enhance patient safety. #pharmacovigilance #drugsafety #pv #mhra #meddra #uk #vigilance #pharmacovigilanceSoftware #PharmacovigilanceSoftware #PharmacovigilanceSoftware #DrugSafetySolutions #PharmaSafetyTools #AdverseEventReporting #MedicationMonitoring #DrugSafetySoftware #PVSystem #PharmacovigilanceTech #PharmaDataSafety #DrugSafetyCompliance #SafetySignalDetection #PharmaceuticalSoftware #PVAnalytics #DrugSafetyReporting #PharmaRiskManagement #PatientSafetySoftware #PharmacovigilanceAutomation #SafetyDataManagement #PharmaRegulatoryCompliance #DrugSafetyAlerts #PVTechnology #MedWatchSoftware #PharmaAdverseEvents #DrugSafetyMonitoring #PVAnalyticsTools #Pharmacoepidemiology #PharmaComplianceSolutions #AdverseEventManagement #SafetySignalAnalysis #PharmaQAQC #DrugSafetyMonitoringSystem

New HMA-EMA Catalogues of Real-World Data Sources and Studies launched. The introduction of the HMA-EMA RWD Catalogues on 15 February 2024 represents a significant advancement in the field of healthcare research, specifically in pharmacoepidemiology and pharmacovigilance. This initiative is a part the growing recognition of the value of real-world evidence (RWE) in complementing trial data and is aimed at harnessing real-world data (RWD) for improving the development, approval, and monitoring of medications. The use of RWD from sources outside of traditional clinical trials (health records, insurance claims etc.), should give invaluable insights into drug efficacy, safety, and patient health outcomes in real-world scenarios. You can find more information from the EMA here https://lnkd.in/gyCbk27U Help our team to grow and deliver for other businesses by sharing this post and following our page – thank you. Aegisana is at the forefront of the evolution of life sciences services with efficient and effective Pharmacovigilance and Auditing solutions. www.aegisana.com #clinicaltrials #gcp #pharmacovigilance  

Exciting Update: I've just received my Professional Certificate in Pharmacoepidemiology & Pharmacovigilance from the London School of Hygiene & Tropical Medicine and thrilled to share some details of this remarkable program! 🌐 This course was a profound journey, equipping me with a comprehensive understanding of critical aspects that shape the safety and effectiveness of medications. Throughout the course, I: Delved into the complex landscape of drug use in humans, exploring the intricate risks and benefits. I critically evaluated the causes, manifestations, and consequences of adverse drug effects (ADEs), understanding how they are detected and monitored in the context of historical and legal frameworks governing drug safety. Developed a deep familiarity with fundamental statistical, and epidemiological concepts and methods. Gained a profound understanding of essential pharmacoepidemiological concepts and methods. Mastered the art of critically analyzing the results of pharmacoepidemiological studies. The course content was a rich tapestry of knowledge. We delved into the historical and legal foundations that underpin the critical field of pharmacovigilance and pharmacoepidemiology. The program also involved a rigorous project that required us to analyze five articles and write a comprehensive report. This project was combined with a challenging exam that tested our understanding of pharmacoepidemiology and pharmacovigilance. It was an incredible international learning experience. Our class included students from different countries, bringing diverse perspectives and insights to the discussions. With this knowledge in hand, I'm eager to contribute to the field of medication safety and public health, making an impact in healthcare decisions and regulatory processes. #Pharmacoepidemiology #DrugSafety #PublicHealth #LondonSchoolofHygieneAndTropicalMedicine

30 common interview questions for a Clinical Research Associate (CRA) role: 1. Can you explain your experience and background in clinical research? 2. What motivated you to pursue a career as a CRA? 3. Describe the key responsibilities of a CRA in a clinical trial. 4. How do you ensure patient safety and regulatory compliance during a clinical trial? 5. What steps do you take to ensure data integrity and accuracy? 6. Can you give an example of a challenging situation you've faced during a clinical trial and how you resolved it? 7. How do you manage and prioritize multiple tasks in a fast-paced environment? 8. What strategies do you use for effective communication with study sites and sponsors? 9. How do you handle disagreements or conflicts with investigators or study personnel? 10. Explain the process of site initiation and monitoring in a clinical trial. 11. What documentation and reports do you typically create and maintain during a trial? 12. How do you stay up-to-date with the latest regulations and guidelines in clinical research? 13. Describe your experience with electronic data capture (EDC) systems. 14. How do you ensure patient recruitment and retention in a clinical trial? 15. Can you discuss a time when you identified a protocol deviation and the steps you took to address it? 16. What strategies do you employ to ensure that a clinical trial stays on schedule? 17. How do you approach risk assessment and mitigation in clinical trials? 18. Discuss a situation where you had to adapt to changes in a study protocol. 19. What qualities make a successful CRA, and how do you embody these qualities? 20. Explain the purpose and importance of informed consent in clinical trials. 21. How do you maintain confidentiality and protect patient data in your role? 22. Can you give an example of a challenging monitoring visit and how you handled it? 23. How do you handle tight timelines and urgent requests from sponsors? 24. Discuss a time when you had to handle an unexpected adverse event during a trial. 25. Describe your experience working with international study sites and managing cultural differences. 26. How do you ensure that investigational products are handled, stored, and administered correctly? 27. What do you do when a site consistently fails to meet enrollment targets? 28. How do you handle situations where there are discrepancies between site records and source documents? 29. Describe a successful collaboration you've had with a site or investigator. 30. What do you think sets you apart from other candidates applying for this CRA position? Remember, the key to a successful interview is not just knowing the answers to these questions, but also being able to provide specific examples from your experience to showcase your skills and abilities as a Clinical Research Associate.

🔍 Uncovering Hidden Site Challenges at the SIV! 🔍   As CRAs, we ensure the smooth execution of clinical trials and guarantee the integrity of data collected at investigational sites.   During SIVs, we strive to help the sites establish a solid foundation for the trial. However, sometimes, sites may not fully recognize or disclose certain obstacles they might face. Unearthing these hidden challenges is crucial to proactively addressing potential issues, supporting the site, and maintaining the trial's success.   Here are some tips and strategies to help our CRAs uncover those elusive obstacles:   ✅Establish Open Communication: Foster a supportive and trusting relationship with the site staff from the outset. Encourage open communication channels so they feel comfortable discussing any challenges they might be experiencing. Dive deeply into each topic on the SIV slides and discuss them individually to identify any potential roadblocks to site recruitment/enrollment.   ✅Ask Probing Questions: Go beyond the standard checklist during the SIV. Ask thoughtful and detailed questions about their processes, resources, staffing capabilities, and prior experiences to identify potential red flags.   ✅ Listen Actively: Listen closely to verbal and non-verbal signals during conversations. Sometimes, sites may indirectly hint at underlying challenges without explicitly stating them.   ✅Review Previous Data: Analyze the site's historical data and performance from similar previous trials to spot recurring issues hindering their efficiency.   ✅ Engage with Multiple Staff Members: Speak with various team members involved in the trial's conduct. Different perspectives might reveal unique challenges faced by other roles within the site.   ✅Observe Site Operations: During your visit, observe the site's operations. Witnessing their processes firsthand can provide insights into potential inefficiencies or resource constraints.   ✅Compare Site Metrics: Benchmark the site's metrics against similar sites in the past to identify any potential issues or areas of improvement.   ✅ Network with Other CRAs: Connect with fellow CRAs to share experiences and learn from each other's insights. They may provide valuable advice on detecting hidden challenges.   ✅Support and Offer Solutions: When you do uncover hidden obstacles, be proactive in offering support and collaborative solutions. A problem-solving approach can strengthen the site's confidence in overcoming challenges.   As CRAs, we play a pivotal role in ensuring the success of the sites and clinical trials. By employing these strategies, we can better equip ourselves to detect and tackle hidden site challenges, support our sites, and drive toward more efficient and successful trial execution.   #ClinicalResearch #CRALife #SiteInitiation #ClinicalTrials #clinicalmonitoring #HowtoSnagThatFirstCRAjob

MedDRA Version 27.0 - What’s New in MedDRA Version 27.0 This What’s New document contains information on the origins and types of changes made to the Medical Dictionary for Regulatory Activities (MeDRA) between Versions 26.1 and 27.0. 𝐒𝐞𝐜𝐭𝐢𝐨𝐧 2, Version 27.0 Change Requests, provides a summary of information on the number of change requests processed for the version. 𝐒𝐞𝐜𝐭𝐢𝐨𝐧 3, New Developments in 𝐕𝐞𝐫𝐬𝐢𝐨𝐧 27.0, highlights changes in 𝐕𝐞𝐫𝐬𝐢𝐨𝐧 27.0 related to change request submissions, new initiatives, information on 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐢𝐬𝐞𝐝 𝐌𝐞𝐝𝐃𝐑𝐀 𝐐𝐮𝐞𝐫𝐢𝐞𝐬 (SMQs), and any recent updates to software tools provided by the 𝐌𝐒𝐒𝐎. 𝐒𝐞𝐜𝐭𝐢𝐨𝐧 4, 𝐒𝐮𝐦𝐦𝐚𝐫𝐲 𝐨𝐟 𝐂𝐡𝐚𝐧𝐠𝐞𝐬, 𝐜𝐨𝐧𝐭𝐚𝐢𝐧𝐬 𝐝𝐞𝐭𝐚𝐢𝐥𝐬 𝐨𝐧: - The impact of this version on the terminology (in tables) - Impact on the records in MedDRA files - MedDRA term and SMQ counts - LLTs in MedDRA that had a currency status change Referance: https://lnkd.in/d3wCKVZs #pharmacovigilance #drugsafety #pv #mhra #meddra #uk #vigilance #pharmacovigilanceSoftware #PharmacovigilanceSoftware #PharmacovigilanceSoftware #DrugSafetySolutions #PharmaSafetyTools #AdverseEventReporting #MedicationMonitoring #DrugSafetySoftware #PVSystem #PharmacovigilanceTech #PharmaDataSafety #DrugSafetyCompliance #SafetySignalDetection #PharmaceuticalSoftware #PVAnalytics #DrugSafetyReporting #PharmaRiskManagement #PatientSafetySoftware #PharmacovigilanceAutomation #SafetyDataManagement #PharmaRegulatoryCompliance #DrugSafetyAlerts #PVTechnology #MedWatchSoftware #PharmaAdverseEvents #DrugSafetyMonitoring #PVAnalyticsTools #Pharmacoepidemiology #PharmaComplianceSolutions #AdverseEventManagement #SafetySignalAnalysis #PharmaQAQC #DrugSafetyMonitoringSystem #medra #medra27 #medranewversion #regulatoryupdates #regulatoryupdate #cro

MedDRA Version 27.0 - What’s New in MedDRA Version 27.0

PASLI disease is a rare genetic disorder of the immune system. PASLI stands for “p110 delta activating mutation causing senescent T cells, lymphadenopathy, and immunodeficiency.” The immunodeficiency manifests as recurrent infections usually starting in childhood. These include bacterial infections of the respiratory system and chronic viremia due to Epstein–Barr virus (EBV) and/or cytomegalovirus (CMV). Individuals with PASLI disease also have an increased risk of EBV-associated lymphoma. Investigators Carrie Lucas, Michael Lenardo, and Gulbu Uzel at the National Institute of Allergy and Infectious Diseases at the U.S. National Institutes of Health and Sergey Nejentsev at the University of Cambridge, UK simultaneously described a mutation causing this condition, which they called activated PI3K delta syndrome (APDS). Discover more about OPIS experience on opisresearch.com! #OPISstudy #immunology