Federation of Awarding Bodies (FAB)’s Post

I’m excited to attend this event organized by the Federation of Awarding Bodies (FAB) "Excited" may seem a bit strong, and while regulatory compliance may not seem like a thrilling subject, it plays a crucial role in ensuring qualifications adhere to high standards of fairness, reliability, and credibility. By upholding compliance with the conditions set by qualification regulators, we protect learners and employers alike, guaranteeing that qualifications accurately reflect essential skills and knowledge. Moreover, qualification regulators foster transparency in assessment processes and step in when standards are not met. The ultimate aim of regulatory compliance is to ensure qualifications remain valuable, trusted, and consistent across both education and employment sectors. So, while it may not be the most glamorous topic, regulatory compliance truly is the foundation upon which everything we do is built. I also know that any event arranged by FAB will be very well organised, informative, and there will be a great selection for lunch 😉

The University of Birmingham, which is a major clinical research hub, recently acquired a Quality Management System (QMS). It will ensure that the institution adheres to a set of strict quality standards. This will ensure that staff is safe during studies and that findings are credible. What are your thoughts on this story? Please share them in our comment section below. Find more here: https://heyor.ca/y1VbUp #UniversityOfBirmingham #QualityManagementSystem #QMS

👩🏫 Did you know, the Institute of Regulation now proudly offers four different professional development courses in regulation? 👨🏫 1. Introduction to regulation - a two hour online introduction to regulation, with PA Consulting 2. Understanding regulation - a compact one day course, covering the essentials of regulation, with Professor Martin Lodge. 3. Fundamentals of regulation - a popular two day course, exploring regulatory theory and current practices, with Professor Martin Lodge. 4. Masterclasses in regulation - offered as a series of evening seminars and newly as a two day course for regulatory executives and non-executives, with Professor Jeroen van der Heijden 👉 Check out the course prospectus for full course details and book your place https://lnkd.in/eZWpA4XW 👈

🔔 Poll Results & Key Insights: E8(R1) & E6(R3) Updates Last week, we asked you a challenging question in our poll: What are the items new in E8(R1) AND expected to be added to E6(R3)? 🖋 Here’s how you responded: - Fit for Purpose: 14% - Risk-Based Quality Management (RBQM): 48% - Quality Culture: 3% - Options 1 and 3 (Fit for Purpose + Quality Culture): 34%  🔍 The correct answer? Options 1 and 3 – "Fit for Purpose" and "Quality Culture". These two elements are new in E8(R1) and are expected to be incorporated into E6(R3). Let’s break it down:  1️⃣ Fit for Purpose: Not a brand-new concept, but crucial nonetheless. This principle emphasizes that products, services, or data should meet stakeholder expectations—whether it’s study sponsors, regulators, medical personnel, or patients. In the clinical research context, “Fit for Purpose” is a cornerstone of both E8(R1) and E6(R3), ensuring that the quality of information generated supports sound decision-making while protecting participants. 2️⃣  Quality Culture: This concept revolves around fostering an environment where quality is a fundamental priority. E8(R1) encourages creating a culture that values critical thinking and open dialogue, moving beyond just tools and checklists. E6(R3) builds on this by integrating quality into every aspect of trial design and development, ensuring a proportionate, risk-based approach.  ⁉ Why not RBQM? Stay tuned for next week’s poll where we’ll dive into why "RBQM" didn’t make the cut as the correct answer this time. Keep engaging with us for more insights and updates! #ClinicalTrials #QualityCulture #GCP #ClinicalResearch #RBQM #Quality #e6r3 #e8r1 #QualityAssurance

Ready to elevate your skills in Risk-Based Quality Management? The RBQM Mastery Bundle combines two key courses—White Belt and Green Belt—to guide you from beginner to proficient in just 8 hours. 🚀 🎥 Watch the video below to see what the Green Belt e-course has in store! What's Included: ✅ White Belt e-Course: 90 minutes to establish a strong foundation in RBQM, ideal for any clinical professional focused on risk. ✅ Green Belt e-Course: Develop your clinical risk management skills with a comprehensive 6-hour program, featuring practical exercises for real-world application. Why Enroll in the RBQM Mastery Bundle? >>Learn at Your Own Pace: Study whenever it suits you, starting immediately. >>Bonus Tools: Get the Risk Management Plan Tool and exclusive KRI Set right after you sign up. >>Certification: Earn your Green Belt certification and join the MyRBQM® Academy Alumni network. Take this opportunity to gain the knowledge and skills needed to manage risks effectively and enhance clinical trial outcomes. Start your journey toward becoming an RBQM expert today! 👉 Enroll Now to get started: https://lnkd.in/dXNXaGZE #ClinicalTrials #ClinicalResearch #GCP #ICH #MDR #Biotech #Pharma #MedTech #ClinicalMonitoring #ClinicalOperations #RBQM #RBM

📚 𝐑𝐞𝐯𝐢𝐬𝐞𝐝 𝐑𝐓𝐎 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐢𝐧 𝐕𝐄𝐓 𝐀𝐮𝐬𝐭𝐫𝐚𝐥𝐢𝐚 🔄 From initial consultations in Dec 2020 to the full implementation expected in Jan 2025, discover how the standards for RTOs are evolving to enhance quality, flexibility, and innovation in training. 𝐊𝐞𝐲 𝐦𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞𝐬 𝐢𝐧𝐜𝐥𝐮𝐝𝐞: 1. Initial Consultations (Dec 2020 - Sept 2021): Stakeholder engagement to identify issues and evaluate existing standards. 2. Early Draft Development (Oct 2021 - Oct 2022): Research and collaboration to shape new standards. 3. Public Consultation (Nov 2022): Gathering feedback for further refinement. 4. Revised Draft Release (Oct 2023): Piloting revised standards with VET regulators. 5. Early Changes Implemented (March 2024): Addressing workforce pressures and providing immediate benefits. 6. Full Revised Standards (Jan 2025): Comprehensive implementation for RTOs. 𝐓𝐡𝐞 𝐫𝐞𝐯𝐢𝐬𝐞𝐝 𝐬𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐚𝐢𝐦 𝐭𝐨: a. Enhance quality outcomes for learners. b. Provide clearer, less prescriptive standards. c. Allow for more flexible and innovative training approaches. d. Move towards a self-assurance model for the sector. 🔗 For more details, visit DEWR, VET Resources, and ASQA: DEWR Quality Reforms [https://lnkd.in/gpC4gBsa] VET Resources [https://lnkd.in/guUAuK56] ASQA Revised Quality Standards [https://lnkd.in/ga5K9XPv] Stay ahead and ensure your RTO is prepared for these transformative changes. #VET #RTO #TrainingStandards #EducationReform #QualityEducation

🌟 Avoid These ACCME Accreditation Mistakes! 🌟 Access the full article here: https://bit.ly/4fyKepy Misunderstanding ACCME standards 🛑 Poor planning or vague learning outcomes 📋 Skipping evaluations or feedback 📊 Inconsistent documentation 🗂️ Ignoring COI policies ⚖️ Underestimating the timeline ⏳ 💡 Plan, document, and comply for success! #CME #Medicaleducation #ACCME #eMedEvents #providers #accreditation

CSQM 1 deadline 📅 has come and gone... yet many practitioners are still struggling with what it means and how to implement for their firm 😕. Take a breath; I am here to help and save you time. 🥳 If you are still trying to figure it all out, are unsure what to do, or feel overwhelmed 😖, take comfort... you are not alone. Even though we have passed the effective date, many firms have yet to implement the requirements of CSQM 1. You still have to get it done 🎯... so why not meet the standards in a way that is practical, efficient and of value to your firm. I am still holding CSQM 1 workshops to help practitioners. Imagine the weight 🏋️♀️ off your shoulders when at the end of the day and you are done. 💻The next workshop date is July 10. Here are comments from last week's workshop: Avni Desai, CPA, CA said "I want to express my heartfelt gratitude for dedicating your entire day yesterday to assist us with the new CSQM 1 requirements. Your hard work and commitment turned what felt like a mountain into a molehill. Your expertise and dedication made a significant difference, and we couldn't have done it without you. You are truly awesome! Thank you so much for your outstanding support!" Lori Mercer said: "I wanted to thank you for the course you put on Jregarding the implementation of the CSQM. I started it on my own in October 2022 and got about 3/4's of the way through and did not finish. It was so overwhelming. I am amazed at what you had us accomplish in a day. Thank you so much. It was well worth the investment." Shannon McNair said: "THANK YOU for the wonderful day on Tuesday. All the partners found the session valuable and we plan on implementing a few best practices you mentioned throughout the day. I feel such relief at getting this done. Worth every penny." Those comments bring me joy. I am so happy to have helped. CSQM 1 is much more than just creating a "manual". Join me as I share a practical and efficient approach to implementing the requirements of the standard. Check out details of the July 10 workshop here 👇👇👇 https://lnkd.in/gw4-t8za

🕔 LAST CALL 🕔 Join our free one-hour mindsON RBQM Workshop tomorrow when our industry experts, Keith Dorricott and Johann Proeve, swim in the Alphabet Soup of RBQM! mindsON RBQM | Episode 25 - Wed, 29 May - 5 pm CEST - 11 am EDT CSM, CM, QbD, RBM... The differences, similarities, and overlaps between these terms have been the subject of much debate and confusion, and the terms you use might not mean the same to others! Are misunderstandings and undesirable consequences in your clinical trial predetermined? Let's check the ICH E6 (R3) draft. Is the industry settling on definitions for these terms, or will the confusion persist? Sign up here and join the discussion: https://lnkd.in/e35wZ7d3 #QbD #RBQM #ClinicalTrials #RiskManagement #GCP #ClinicalResearch #webinar #Riskbasedqualitymanagement

CASP's CEU Center has dozens of webinars on demand! Check out "Assent-Based Intervention: Crafting the Map on the Journey." https://lnkd.in/gPUxq_qQ Refining teaching procedures to better identify, analyze, and respond to assent and assent withdrawal requires new operational definitions, measurement systems, and staff training challenges. The webinar discusses experiences crafting policies, standards, procedures, and trainings, including a step-wise implementation protocol. Participants collaborated to identify and measure key performance indicators of successful assent-based intervention. This is FREE for CASP members and $20 for non-members, with 2.0 BACB Ethics CEUs available.