Alison McIntosh’s Post

Are you attending #EMWA57 #EMWAconference, Valencia May 2024? We are running the free #COREReference session on Symposium Day - Thursday 09 May - from 09.00-10.30. If you registered for the Symposium, this precluded you from signing up for the simultaneous #COREReference session. However, if you wish to drop by you are most welcome, and we ask that you email to emwaconference@emwa.org with a note of your intention to help us more accurately estimate the number of potential participants. Agenda:  * Value of #COREReference for #Disclosure-Ready #clinicalstudyreports & Continuing #Professionaldevelopment (CPD) resources * Real life #Policy0070 submissions, including planned versus actual timeline * #Policy0070 Re-launch: Anonymisation Report (AnR) Template and insights on completion * #Medicaldevices CPD, including MD and drugs spaces intersection * #COREReference 2023 Utility Survey Results – An Overview * Breaking news (including the launch of the revised CTIS transparency rules and new CTIS website in June 2024 and the new draft guidance on PPD and CCI within the MAA dossier). We hope to see you on the day. Dr Sam Hamilton, Chair CORE Reference Project

Do you know⭐ What is a Protocol ? A Protocol is a study plan on which a clinical trial is based. It is designed to describe what type of people may participate in the trial, schedule of tests to be conducted in the trial, procedures to be undergone e.g. medications, dosages or length of the study. The protocol is the operating manual for the clinical trial which ensures that researchers performs the trial in the same way with the same characteristics. According to the ICH Good Clinical Practice guidelines, a protocol should include the following points :: •Title Page ( General Information) •Background Information •Objectives/ Purpose •Study Design •Selection and Exclusion of Subjects •Treatment of Subjects •Assessment of Efficiency •Assessment of Safety •Adverse Events #clinical #clinicaltrials #CDM #clinicalresearch #clinicaldatamanagement #EDC

📢 Last chance to register! Don't miss tomorrow's webinar ‘Mastering the clinical evaluation of medical devices’. 🏥 Secure your place now to get valuable information on how to navigate the clinical evaluation process. 💡 In addition to Sandra Balseiro and Celeste Oliveira's presentation on ‘Understanding regulatory requirements for clinical evaluation’, CRO, NOVA Clinical Research Unit (NOVA CRU) will also be sharing insights. Plus, João Correia Leite, from Insparya Portugal, will talk about his first-hand experience. 📅 Date: Tomorrow - 14/05, online 🕜 Time: 14h30 (GMT+1)  🔗 Register Here: https://lnkd.in/dwCRzbKS #IPN #MDRu #clinicalevaluation #medicaldevices #CRO #regulatorysupport #regulatoryaffairs #webinar #freewebinar #MDR #investigation hashtag #clinicalinvestigation #requirements #compliance

🧐 Are you seeing more patients who are either using or considering GLP-1/GIP agonists? Or maybe you’ve been asked how to support their body’s natural production of incretins? Join Jocelyn Strand, ND, our Senior Director of Clinical Education, at GastroANP's annual conference to learn: ✅ The role these medications currently play ✅ New areas of activity being discovered ✅ How incretins are produced naturally and released in the gut This is a must-attend for any practitioner looking to optimize patient outcomes in this fast-evolving space. We'll see you there! https://lnkd.in/gj44Ug2D #NaturopathicMedicine #GLP1 #GutHealth #GastroANP

As per our dedication in MARC to develop our knowledge,dealing with new guidelines and regulations in clinical research I’m happy to share that I have finished principles of Clinical Research from The National Institutes of Health 🎊🎉🎉 it was very fruitful materials،contained valuable information about History of Clinical Trials,GCP,Study design,Study protocol.✌🏻✌🏻 #GCP #Clinical #Bioequivelance #ClinicalTrials #CRO

In Part 1 of this series, we spoke about the overall changes expected in ICH-GCP R3, and what has changed, particularly the impact on trial participants and the adaptations to this guideline in relation to new trial methods. In Part 2, we will explore the changes to the annex and how this impacts clinical trials. Read more https://hubs.li/Q02TcQGP0 #GCPCentral #ThereIsABetterWay #ICHGCPR3 #ClinicalTrials

VCTC’s Virtual Trial Site does everything that a traditional clinical trial site does. In terms of IP, traditional sites release IP from their onsite pharmacy, we distribute drugs via our central pharmacy and ship directly to patients' homes via our specialist courier service. Flexibility is key for our participants, and IP shipping is one of many services we offer that enables them to take part in our trials from the comfort of their own home, confident that they will be well looked after. Check out this case study to find out how we ensured IP shipments reached our patients on time, every time as part of this complex CTIMP trial. 👉 https://lnkd.in/ggMDAKc4 #VCTC #TheVirtualClinicalTrialCentre #ClinicalTrials #TheVCTC #DecentrialisedTrials #PatientCentricity #EmpoweringPatients #FutureofHealth

🚀 Quality Tolerance Limits (#QTLs) are essential for managing risk and ensuring quality in clinical trials. Whether it's patient safety 🩺, data integrity 📊, or trial validity, QTLs help keep your study on track by focusing on what matters most. Establishing QTLs at the protocol design stage, based on medical expertise💉and historical data📚, ensures a strong foundation. Our approach prioritizes 3 to 5 key parameters, tailored to your study’s unique risks. Curious about the 7 key QTLs every clinical trial needs? 🤔 https://lnkd.in/e4nWfhqT #ClinicalTrials #RiskManagement #QualityManagement #QTLs #Pharma #Cyntegrity #ClinicalResearch #GCP #PharmaTech

Did You Know? The PEBC OSCE tests your pharmacy knowledge, communication, and patient care skills through real-life scenarios. It’s one of the most practical and challenging parts of the exam! Stay tuned for more insights! #PEBC #OSCEExam #Canada #PharmacyCareer #Pharmacists #internationalPharmacygraduates

FDA published a draft guidance, "Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies": https://lnkd.in/gNczUwNA This draft guidance describes: ➡Format and content of Diversity Action Plans ➡The medical products and clinical studies for which a Diversity Action Plan is required ➡Timing and process for submitting Diversity Action Plans to the FDA ➡Waiver requests #guidancedocument #Clinicalstudies #ClinRT