WCG’s Post

Are you a #clinicalresearch professional looking to enhance your quality/regulatory expertise? Join MAGI@home for the Quality / Regulatory track! Understand and ensure adherence to the regulations on research participant protections with the Quality/Regulatory Track from MAGI@home. Join experts for insightful sessions, including: 🌎Ensuring quality in Real-world Evidence (RWE) 📝Back to the basics: Insights into regulatory guidelines and regulations 👀A two-part session on Preparing for FDA Audits: Are you ready when the FDA comes calling? 🔍Navigating the next steps of ICH E6(R3) 🤝Site feasibility: the critical role of stakeholder engagement Register for MAGI@home 2024 now at https://lnkd.in/eZ6Yqnam #WCG #MAGI #Quality #Regulatory #ClinicalTrial #ClinicalResearch #FDAaudit #SiteFeasibility

We all know what a cluster MDR has proven itself to be, but sometimes it's worth hearing about it from someone on the front lines. Someone besides me, that is. 😆 SGS North America will host a webinar on MDR on January 18th at 2pm Eastern to review how we ended up in this mess, and what manufacturers need to do to move forward. They'll share highlights of the EU Commission's survey of #notifiedbodies that they published in July 2023, review the key requirements of Regulation (EU) 2023/607 (Entry Into Force), walk you through the MDCG Q&A Document, and discuss that ever-popular diatribe MDCG 2022-11 Rev.1, the “Call to manufacturers to transition to the Regulations and submit their applications for certification without further delay” SGS has been in the thick of it for a while now, so they have first-hand knowledge of the reality of MDR - and the realities of the extension and its effect on the number of certification applications (hint: very little 😕). Click here to register and hear their take on MDR: https://lnkd.in/gjVqWUDY #medicaldevices #eumdr #regulatoryaffairs #compliance #europe #medtech #biotech

This has been a busy week for Emergo by UL. We’ve been catching-up on some regulatory updates and sharing those, as well as continuing to monitor regulatory developments. This is a current update. The regulator in Australia, TGA, updates the recall guidance, Uniform Recall Procedure for Therapeutic Goods (URPTG). Recall (ha!) that the categorization of the risk of recalls in Australia is analogous to the US FDA: Class I very serious, Class III not quite as risky. This revision is Version 2.4, and changes have been implemented post discussions and proposed reforms in 2021-2023. Review our Regulatory Update (thanks to our Manager of our Global Vigilance program, Elizabeth Pugh, and one of our vigilance experts, Amelia Boldrick): https://lnkd.in/g5cPHPZU . Image of page 23 of the URPTG. #medicaldevice #regulatory #regulatoryaffairs #tga #urptg #medtech #regulatorycompliance #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory

Navigating the EU and UK cosmetic markets? 🇪🇺🇬🇧 Discover the 5 essential steps for product placement, PIF creation, and regulatory compliance. Our experts simplify the journey, offering guidance, PIF creation, Safety Data Sheets, and clinical testing support. For peace of mind and successful market entry, connect with our compliance team today. Let ADSL's expertise guide you. Learn more now! https://lnkd.in/euC_7_Hh #CosmeticRegulations #EUUKCosmetics #ComplianceExperts

IQVIA's 26th Controlled Substance and State Regulatory Conference Registration for our annual conference has opened! Please join us in Louisville, KY for industry's premiere event delivering insights for regulatory excellence. Here's a link to register: https://lnkd.in/gqGf7-f6 Conference dates are September 18-20 at the Galt House Hotel. Here's a quick look at the current agenda which incluldes general sessions, breakout groups, and interactive roundtables. Topics are subject to change. * Update by DEA Headquarters on regulations and compliance efforts (confirmed) * Tomorrow’s Regulations Today – What’s Ahead for SOM * Navigating the New Quota Requirements * Insights and Takeaways from the Current Enforcement Environment * State Regulatory Updates - Registration, Reporting and Other Controlled Substance Considerations * Drug Supply Chain Security Act: Ready or not! New to Controlled Substance Compliance? Join our DEA 101 breakout session to build foundational knowledge and gain insights addressing regulatory pitfalls and industry challenges.

IQVIA's 26th Controlled Substance and State Regulatory Conference Registration for our annual conference has opened! Please join us in Louisville, KY for industry's premiere event delivering insights for regulatory excellence. Here's a link to register: https://lnkd.in/gqGf7-f6 Conference dates are September 18-20 at the Galt House Hotel. Here's a quick look at the current agenda which incluldes general sessions, breakout groups, and interactive roundtables. Topics are subject to change. * Update by DEA Headquarters on regulations and compliance efforts * Tomorrow’s Regulations Today – What’s Ahead for SOM * Insights and Takeaways from the Current Enforcement Environment * State Regulatory Updates - Registration, Reporting and Other Controlled Substance Considerations * Drug Supply Chain Security Act: Ready or not! New to Controlled Substance Compliance? Join our DEA 101 breakout session to build foundational knowledge and gain insights addressing regulatory pitfalls and industry challenges.

If you need to stay on track with #regulatory authority compliance requirements – from EDQM doses and formulations, to WHO MPID mapping – IQVIA’s solutions offer a rapid response for complete compliance. Ready to discover how we can help your #PV organization to stay focused on the tasks that matter? Let’s talk! https://bit.ly/3Vf5E4u

In #BurkinaFaso, the USAID-funded PQM+ program works to build the capacity of the national quality control laboratory to conduct quality control testing of medical products. The results help to inform regulatory actions on substandard and falsified medicines. Learn more here: https://ow.ly/4yGe50PPKpP #HealthSystems

🌐 FDA withdrew its membership in the Global Harmonization Working Party (GHWP) after concluding the group “does not offer the opportunity for FDA and other regulatory bodies to have our voices heard and considered.” ✍️ The US agency criticized the Global Harmonization Working Party for diluting the perspective of regulators and modifying documents from other organizations in its November 17 decision to withdraw from the group. 🤝 FDA says it will devote all of its harmonization efforts to IMDRF, which it will be chairing in 2024: https://bit.ly/3QTumDS #medtech #medicaldevices #fda #ghwp #globalharmony #regulatory #regulatoryaffairs

#RegUpdatesWithRegDesk To enhance the oversight of medical device operations, standardize practices, and ensure the safety of devices for public use, the State Food and Drug Administration has updated the "𝐐𝐮𝐚𝐥𝐢𝐭𝐲 𝐌𝐚𝐧𝐚𝐠𝐞𝐦𝐞𝐧𝐭 𝐒𝐭𝐚𝐧𝐝𝐚𝐫𝐝𝐬 𝐟𝐨𝐫 𝐌𝐞𝐝𝐢𝐜𝐚𝐥 𝐃𝐞𝐯𝐢𝐜𝐞 𝐎𝐩𝐞𝐫𝐚𝐭𝐢𝐨𝐧𝐬."  These revisions, effective from July 1, 2024, replace the previous announcement (2014 No. 58) on the implementation of quality management standards. The aim is to align with laws and regulations, promoting industry standards and the overall safety and effectiveness of medical devices. Link: 👉 https://lnkd.in/gv7u3MzX Follow: 👉 RegDesk and get daily regulatory alerts sent straight to your inbox. Get Started: 👉 https://lnkd.in/d8yWnPkj #MedicalDeviceSafety #QualityManagement #IndustryCompliance #NMPA #China