Monir El Azzouzi’s Post

📢 I’m speaking at @CHPA’s Regulatory, Scientific & Quality Conference (RSQ) tomorrow! Learn more about my session, the full conference program, and registration here >>> chpa.org/rsq #CHPARSQ24 

To comply with EU CTR, who is responsible for retaining the TMF? How long do I need to retain it for? Does EU CTR reference the ALCOA+ principles? We cover these questions and more in our latest blog post exploring the retention requirements outlined in the EU clinical trial regulation (EU Reg 536/2014). Read here: https://lnkd.in/eaYgnTWf

Exciting news! I'm thrilled to invite you to our upcoming webinar on PFAS regulations and compliance strategies. As one of the speakers, I'll be joining my esteemed colleagues Chuck LePard and William Martin for EPR Consulting Ltd to provide you with the most up-to-date information on this critical topic. In this informative session, we'll explore: 🌎 The current landscape of PFAS restrictions in the US, EU, and UK 📊 Evolving regulatory trends and their potential impact across industries 🔬 Strategies for efficient PFAS data collection, focusing on the most relevant 3,000 compounds out of 15,000 Don't miss this opportunity to stay ahead of the curve on PFAS compliance. Join us to gain valuable insights and practical solutions for navigating these complex regulations. Looking forward to seeing you there! #PFASRegulations #ComplianceStrategies #EnvironmentalSafety

Delighted to share that UNECE: Working Party on Regulatory Cooperation and Standardization Policies (WP.6)'s "Recommendation L" - and its revision where our founding director Markus Krebsz has contributed over the last months - has now been made available for a 30-day public review. Recommendation L lays out the United Nations international model for product/service conformity based on transnational regulatory cooperation. It provides a structured template covering incl. 1) Scope, 2a) Product/service requirements & 2b) Int. Standards, 3) Compliance clause and 4) Market surveillance clause and thereby helps with the alignment of international regulatory practices. Although a separate product, the analysis and development of a UN CRA (Common Regulatory Arrangement), led by Prof. Krebsz, has been considered as a use case to see if/how Recommendation L may apply. After completion of the public review, the project team will look at comments received and then finalised the text for this important international regulatory model. More information about the UNECE WP.6 START project tasked with the revision of Recommendation L may be found here: https://lnkd.in/eXtjrUKn Prof. Divya Dwivedi

Beyond Standardization! SABS Non-Regulatory Role In the manufacturing and production industry, the Bureau of Standards plays a critical role in formulating and inspecting the standard quality and quantity of products presented to regional consumers. The South African Bureau of Standards (SABS) is more than just a standardization body; it empowers businesses to achieve the set product standards. In this article, Catherine Odhiambo unravels SABS's role in shaping South Africa's manufacturing and production landscape, taking us on a journey beyond the organization's regulatory role. Ready to learn more about the impactful role of SABS? Dive into this insightful article: https://lnkd.in/dEnK-7fg

Join us at #SALGBA2024 for an insightful discussion on what public sector benefits leaders need to know about GLP strategies! 

If you haven’t been reading the articles here on LinkedIn by CPCA’s President & CEO, @J. Gary LeRoux, then join us at the conference as he dives into the many regulatory challenges facing the CASE industry. CPCA has called for a ‘whole of industry’ approach to bringing balance and science back when it comes to regulatory change. Hear how CPCA member companies are working to ensure better regulatory outcomes for the entire industry. Join us at the conference, and register today. https://lnkd.in/epWuHHME

How do you approach challenges in your work? 🧐 We talk about them…. 🌟 A huge thank you to everyone who organized, attended, and contributed to last week's Northern Regional Forum! 🙏 It was an honour to be involved, and I truly enjoyed hosting the open Q&A on CSV—honestly, it was better than running through my slides! 😄 The engagement and insightful questions from the audience made it a standout session. Special thanks to the Medicines and Healthcare products Regulatory Agency for your openness and participation and to my fellow Research Quality Association (RQA) members for your invaluable contributions. Here are some thought-provoking topics that sparked great discussions: 🧐 Validated vs. Qualified Systems: What’s the real difference, and why does it matter? ⚖️ Gaps in Compliance: Should we pause usage until gaps are fixed, or manage compliance in parallel? 🔍 Testing Off-the-Shelf Systems: Are our testing protocols sufficient, or do we need to dig deeper? 💡 Clinical Lab Data Systems Validation: How rigorous should we be with these critical systems? 📦 The ‘Validated Package’ from Vendors: Does buying validation really work? ♻️ Revalidation vs. Change Control: Where’s the line, and how do we keep up? 🚀 Driving CSV When It’s Not Revenue-Generating: How can we shift the mindset? ⏪ Retrospective Validation of Existing Systems: Is it ever too late to validate? 🌐 Open Source Software in Clinical Studies: How do we ensure compliance with non-traditional tools? 🔗 Critical vs. Low-Level Features: Where do we draw the line on validation? These questions are just scratching the surface, and I’d love to hear your thoughts. How do you approach these challenges in your work?

Discover how the recent GDUFA III changes are revolutionizing the ANDA submission process in Diluks De Silva's insightful article! 📝🔍 Stay ahead of the curve with these key revisions for smoother regulatory pathways. https://lnkd.in/efUUVGyb #GDUFAIII #ANDASubmissions #FDAChanges