Join us online for the Medical Writing of PSUR/PRER Training Course, starting on 15 October. Learn more about best practices in source data collection, essential role of quality checks (QC) during the whole process of report preparation, and critical aspects of medical writing, including data editing and presentation. This live-virtual training course will be hosted by: ◾ Sven Schrip, Head of Global Pharmacovigilance Writing, Boehringer Ingelheim, Germany ◾ Jan Kolouch, CEO, Strategic PV Advisor, NextPV Services s.r.o., Czech Republic Don’t miss this unique opportunity to get a firm knowledge foundation on the medical writing of PSUR/PBRER with hands-on exercises. The early bird rate is ending next week. Register today: https://bit.ly/3yMKPEZ. #Pharmacovigilance #DrugSafety #PSUR #MedicalWriting #Learning
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Passionate Pharm D Graduate, Driven by Scientific Inquiry, Seeking Opportunities in Research and Innovation
"Delighted to showcase my successful completion of courses covering pharmacovigilance, clinical research, clinical data management, regulatory affairs, medical devices, and medical writing. These certifications signify my commitment to advancing my skills and expertise in the healthcare sector. Excited to apply this knowledge to drive positive outcomes and innovation in the field. #HealthcareEducation #ContinuousLearning #clinicaldatamanagement #clinicalresearch
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Looking to enhance your skills in Aggregate Reporting? ClinoSol Research brings you an exclusive weekend training program designed for professionals and students eager to master the essential aspects of aggregate reporting in clinical research and pharmacovigilance. 📅 Duration: One Month (Weekends Only) 🎯 Hosted by: Clinosol Research Who Should Attend: Pharmacovigilance Professionals: Those working in drug safety who want to enhance their skills in aggregate report writing and compliance with regulatory standards. Clinical Research Professionals: Individuals involved in clinical trials and data reporting, looking to understand the role of aggregate reporting in clinical research. Medical Writers: Professionals who want to specialize in the technical aspects of writing safety reports, periodic reviews, and risk management documents. Regulatory Affairs Specialists: Individuals working with regulatory bodies who need an in-depth understanding of aggregate reports for drug approval processes. Pharmacy Students/Graduates: Students or recent graduates in pharmacy, life sciences, or related fields, looking to build a career in clinical research or pharmacovigilance. Healthcare Professionals: Doctors, pharmacists, or nurses who wish to better understand pharmacovigilance and safety reporting in healthcare. 🚀 Scan the QR Code or Click on the below link to Register Now! https://lnkd.in/g2AQU-an Don't miss this opportunity to upgrade your career with hands-on training from industry experts! #AggregateReporting #ClinosolResearch #PharmacovigilanceTraining #ClinicalResearch #WeekendTraining #CareerUpgrade #PSUR #RiskManagement #TrainingProgram
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🔬 Scientific Writer 📝 Medical Writer - SLR Expert 📚 Medical Writing Trainer 📊 Enhancing Clinical Outcomes through Quality Research
what is Aggregate Reports.... many of #pharmacovigilance #professionals want to switch in medical writing, So #aggregate Reports writing is the part of medical writing and it come under safety report writing... Aggregate Reports writing require 2 to 3 year of experience in Pharmacovigilance.... for more updates follow Mohd. Aasim Saifi #pharmacovigilance #icsr #aggregate #postmarketsurveillance #clinicaltrials #safety #reportwriting #medicalwriting #medicalwriters
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Hey everyone! 🎉 I'm thrilled to share that I've just completed an advanced program in clinical research and management from CliniIndia! 🙌🔬 Throughout the course, I gained expertise in clinical data management, clinical trial management, pharmacovigilance, and medical writing. 📚 It was an incredible learning experience, and I'm excited to apply my newfound knowledge in the field. 🌟 #CertificationAchievement #ClinicalResearch #ClinicalManagement #Pharmacovigilance #MedicalWriting
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Senior Manager Pharmacovigilance QA at Sun Pharma| ISO 9001:2015 certified lead auditor| Expert in PV inspection handling| Extensive experience of auditing PV sites| Hands on experience in software validation
#Pharmacovigilance #PharmacovigilanceQA #Drugsafety We have discussed some important sources of spontaneous cases in previous posts. Lets talk about literature monitoring today. There are 2 parts to literature monitoring: 1. Global and 2. Local We will discuss Global literature monitoring today: MAH or the vendor used by MAH for this activity should scrutinize global reference data bases for e.g. Embase, Medsafe etc. at least weekly for any safety information emanating about MAH molecules. Relevant medical information should be recorded in the company data base and the first publication author (or the corresponding author, if designated) should be considered as the primary source of information. Regulators expect that: 1. For EEA ( European Economic Area) literature monitoring should start from day of application/ dossier filling and not from grant of authorization or day of marketing. 2. For literature cases MAH should procure full text articles (FTAs) for all abstract be it valid or invalid abstracts. Cases should not be invalidated based on abstract information. 3. Initial receipt date or Day 0 is counted as the date when complete case information (04 minimum criteria to make a valid case) is available with MAH. If MAH is using a vendor then Day 0 is counted from the date vendor becomes aware of this information. 4. Literature search strategy should include checking of both brand names as well as generic (molecule name) for a particular territory. 5. Published seminar proceedings should also be scrutinized for safety information. 6. MAH should check draft manuscripts or ahead of print publications also. 7. If a vendor is being used then MAH should develop mechanism to keep continuous oversight over vendors activities. 8. Follow up of missing safety information (if required) with authors should be done by MAH. Thank you for reading, will discuss local literature monitoring in next post.
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Hello Connections!🎉 🚀"Excited to announce the completion of my Post Graduate Diploma in Clinical Research from Pacifix Research institute under the guidance of Sanjit A D. Equipped with comprehensive knowledge highly skilled and motivated holder in Clinical Research with expertise in Clinical Data Management, Pharmacovigilance, Medical Coding, Medical Writing, and Regulatory Affairs. Ready to contribute to innovative healthcare solutions, advancements and to make a positive impact in the field of healthcare.🎗️ #ClinicalResearch #pharmacovigilance #DataManagement #MedicalCoding #RegulatoryAffairs #HealthcareInnovation"🎯
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B Pharmacy graduate srinivas college of pharmacy Manglore Rajiv Gandhi University of health and science Bangalore
I have completed 6 month course ( pharmacovigilnce, clinical research, medical writing, Quality Assurance, Regulatory affairs)
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Excited to share a significant milestone in my professional journey! 🎉 I have successfully completed certification courses at Clini India, gaining in-depth knowledge and skills in: - Clinical Research Management - Clinical Data Management - Pharmacovigilance - Medical Writing These certifications have equipped me with the expertise to contribute effectively to clinical research and healthcare innovation. I'm eager to apply this knowledge and make a positive impact in the industry. #ClinicalResearch #Pharmacovigilance #MedicalWriting #ClinicalDataManagement #HealthcareInnovation #ProfessionalDeveloment.
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Hello connections, I'm delighted to share that I have successfully completed the "Advance programme in clinical research and management" through E- learning platform. This has provided me a great value in terms of satisfactory knowledge and proficiency in clinical research, clinical data management, pharmacovigilance and medical writing Also I would like to express my gratitude to the #cliniindia organization for providing such a wonderful course. I'm now embarking on a new chapter, open to exciting challenges and eager to contribute to the advancement of healthcare. #clinicalresearch #clinicaldatamanagement #pharmacovigilance #medicalwriting
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Curious about clinical research❓Limited spots remaining❗ Ananya from Labb Research Institute breaks down the essential topics you need to know : clinical trials, pharmacovigilance, data management, medical writing, and regulatory affairs. Gain valuable insights and unlock your potential in this dynamic field. ✨ Watch now and take the first step towards your clinical research goals! that'll launch your healthcare career. ⏳ Seats are filling fast - register NOW! ➡ [www.llri.in] #clinicalresearch #clinicaltrials #pharmacovigilance #clinicaldatamanagement #medicalwriting #regulatoryaffairs #healthcarecareer #learnsomethingnew #labbresearchinstitute #KnowledgeJourney #clinicalresearch #EnrollNow #clinicalresearchers #healthcareinnovation #enrollnow #careergoals✔ #careergoals #couragetogrow #knowledgejourney
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