Stéphanie Val, PhD, RAC’s Post

#FDARegulatoryNewsandTrends: #FDA guidance to extend policy for certain device modifications without regulatory submission; #CDER publishes environmental impact review #ICMRA #ExportCertificates #ClinicalTrials #Thermometers #CBER

Better than us telling you that ValGenesis iRisk is the #QbD tool for CMC development, is seeing it written and published by the hands of the #CMC expert Irwin Hirsh. Take a look 👉https://lnkd.in/d2GjQ4Pc

Join our webinar tomorrow to learn the latest ICH Q2 revision 2 updates. Our specialist speakers, Robert Taylor and Stephen Ward-Smith will navigate you through: - How ICH Q2 impacts laser diffraction - The key updates in revision 2 - Best practices for method validation This updated guideline is critical for validating laser diffraction methods when submitting to regulatory authorities. Your last chance to register 👉 https://bit.ly/3NkAJit 📅 December 12 | 16:30 - 17:30 CET #qualitycontrol #pharmaceuticalanalysis #analyticalmethods

Attended the @IMAPAC Biomanufacturing 5.0 conference and learned about two CMC development tools worth using: the Clinton Go-to-market Toolbox and the soon-to-be-launched CEPI CMC Framework. #biomanufacturing #CMCdevelopment #conferencehighlights

Already Day 3 of #medtechcon, looking forward to the sessions and networking! Find me to talk about CDRH's voluntary MDDT Program and what that means for your product or regulatory review submission! #MDDT #Medicaldevicedevelopmenttools #FDA #CDRH

Our webinar on how taking a phase-specific approach can help you overcome your ATMP project’s CMC challenges has come to an end. If you missed it you can catch up with the discussion via the on-demand recording at any time that suits you. Uncover our expert insights into how this approach can help you overcome these challenges while also: ◼ Saving time  ◼ Reducing costs  ◼ Staying ahead of the ever-evolving regulatory landscape. Watch now: https://lnkd.in/d3T8STpn ?utm_source=LinkedIn&utm_medium=social&utm_campaign=bio_general #ATMPs #CMC #DrugManufacturing #PharmaWebinar 

Metrion Biosciences performed a GLP compliant study in accordance with the ICH E14/S7B Q&A best practice guidelines to generate in-house IC50 values for the FDA's positive control compounds; ondansetron, moxifloxacin and dofetilide. Gary Clark and John Ridley have enjoyed discussions at the #JSPS meeting this week. If you missed them, you can download the poster that presents this case study and find out more about GLP hERG screening at: https://buff.ly/3OLRZOC #Ionchannels #GLP #hERG #CardiacSafety #DrugDiscovery #DrugSafety #LifeSciences #JSPS24 #Screening"

Diving into Analytical #QbD is all about strengthening your Analytical Target Profile and making drug development more efficient 🚀 Check out our Industry Insight for a handy roadmap to help you along the way 👉 https://lnkd.in/dBB3tvyz

👇 Check out our latest blog post on Analytical QbD below! 👇

📌 US FDA has published the new Version (5.7) of the STUDY DATA TECHNICAL CONFORMANCE GUIDE 👉 The following changes has been made in the guide. ➡ Section 4.1.1.3 (SDTM Domain Specifications) – Updates for LB and LC Domain ➡ Section 4.1.3.2 (General Considerations) – Addressed ELTM and DOSDUR ➡ Section 4.1.3.3 (SEND Domain Specifications) – Updates for LB Domain ➡ Section 4.1.4.3 (Naming Conventions in SDTM and SEND) – Addressed naming for drugs and metabolites ➡ Section 8.2.2.3 (Technical Rejection Criteria and Use of a Simplified ts.xpt for Nonclinical Studies) – Language updated ➡ Appendix B – Added new TSPARMCD ➡ Appendix C – Added reference to Section 4.1.3.2 for the DOSDUR TSPARMCD ➡ Appendix D – Updated lists #usfda #studydata #regulatoryaffairs #submission #send #datasets #ectd RegOrbit