Certara’s Post

No, no, not that wee emergency! The FDA's waivers, exceptions, and exemptions program (WEE). Carl Accettura can detail that second one much better than I. And he's got a bunch more acronyms you should get used to. #DSCSA #pharmaceuticalindustry #biotech #serialization #products

💡✨Ready to unleash your regulatory powers like never before? Join us for an electrifying webinar featuring the one and only Raz Eliav, the ultimate CMC Development and Regulatory Affairs expert. 💥 Prepare to have your mind blown as we reveal the hidden secrets to optimizing your regulatory submissions and turbocharging your workflow using the mighty eQMS system. 🚀 🔑 Brace yourself for an arsenal of benefits: ✅ Unlock mind-boggling tips and tricks to capture project knowledge with finesse, even when dealing with more subcontractors than a supervillain's evil lair. ✅Say goodbye to submission struggles and hello to precision and efficiency. ✅Crush the challenges of managing product and process knowledge across organizations and obliterate those pesky information silos. ✅Unleash the full potential of the Quality Management System (QMS) and become a regulatory project management legend. 📆 Date: 21st September 2023 ⏰ Time: 16:00-17:30 CET Berlin. 🔗 Register here: https://rfr.bz/l6l08vr Special thanks to our event sponsor, Qualio, the brilliant minds behind the state-of-the-art cloud eQMS. Without their superpowers, this webinar wouldn't be possible. 🙌🌟 #QualityAssurance #CMCDevelopment #eQMS #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

💡✨Ready to unleash your regulatory powers like never before? Join us for an electrifying webinar featuring the one and only Raz Eliav, the ultimate CMC Development and Regulatory Affairs expert. 💥 Prepare to have your mind blown as we reveal the hidden secrets to optimizing your regulatory submissions and turbocharging your workflow using the mighty eQMS system. 🚀 🔑 Brace yourself for an arsenal of benefits: ✅ Unlock mind-boggling tips and tricks to capture project knowledge with finesse, even when dealing with more subcontractors than a supervillain's evil lair. ✅Say goodbye to submission struggles and hello to precision and efficiency. ✅Crush the challenges of managing product and process knowledge across organizations and obliterate those pesky information silos. ✅Unleash the full potential of the Quality Management System (QMS) and become a regulatory project management legend. 📆 Date: 21st September 2023 ⏰ Time: 16:00-17:30 CET Berlin. 🔗 Register here: https://rfr.bz/l6kgx6u Special thanks to our event sponsor, Qualio, the brilliant minds behind the state-of-the-art cloud eQMS. Without their superpowers, this webinar wouldn't be possible. 🙌🌟 #QualityAssurance #CMCDevelopment #eQMS #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

💡✨Ready to unleash your regulatory powers like never before? Join us for an electrifying webinar featuring the one and only Raz Eliav, the ultimate CMC Development and Regulatory Affairs expert. 💥 Prepare to have your mind blown as we reveal the hidden secrets to optimizing your regulatory submissions and turbocharging your workflow using the mighty eQMS system. 🚀 🔑 Brace yourself for an arsenal of benefits: ✅ Unlock mind-boggling tips and tricks to capture project knowledge with finesse, even when dealing with more subcontractors than a supervillain's evil lair. ✅Say goodbye to submission struggles and hello to precision and efficiency. ✅Crush the challenges of managing product and process knowledge across organizations and obliterate those pesky information silos. ✅Unleash the full potential of the Quality Management System (QMS) and become a regulatory project management legend. 📆 Date: 21st September 2023 ⏰ Time: 16:00-17:30 CET Berlin. 🔗 Register here: https://rfr.bz/l6l08vr Special thanks to our event sponsor, Qualio, the brilliant minds behind the state-of-the-art cloud eQMS. Without their superpowers, this webinar wouldn't be possible. 🙌🌟 #QualityAssurance #CMCDevelopment #eQMS #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

We are super grateful for the +4500 people that are part of our "Accelerating eCTD Submissions" community. And here are 8 reasons why we would love you to join: ✅ Experts insights: Dive deep into key topics for regulatory excellence (Dr. Benita von Glahn), CSV vs. CSA (David Gwyn), and navigating new FDA forms (Premier Consulting). ✅ Global perspective: Gain valuable knowledge on eCTD's global aspects and future directions (Akira Yamaguchi) and stay updated on US FDA's IDMP implementation. ✅ Real-world solutions: Discover practical tips on global dossier management (Steve Gens & Preeya Beczek) and perfecting PDF formats for US FDA (Paul Ireland). ✅ Technology focus: Explore the economics of regulatory innovation (John Cogan) and stay ahead of the curve in the ever-evolving landscape. Stay tuned, as our team is working on more articles & thought leadership sessions for 2024! 𝐎𝐡, 𝐚𝐧𝐝 𝐲𝐨𝐮𝐫 𝐜𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐢𝐨𝐧 𝐢𝐬 𝐰𝐞𝐥𝐜𝐨𝐦𝐞, 𝐭𝐨𝐨! 𝐀𝐫𝐞 𝐲𝐨𝐮, 𝐨𝐫 𝐝𝐨 𝐲𝐨𝐮 𝐤𝐧𝐨𝐰 𝐚 𝐬𝐮𝐛𝐣𝐞𝐜𝐭 𝐦𝐚𝐭𝐭𝐞𝐫 𝐞𝐱𝐩𝐞𝐫𝐭 𝐭𝐡𝐚𝐭 𝐜𝐚𝐧 𝐜𝐨𝐧𝐭𝐫𝐢𝐛𝐮𝐭𝐞? 𝐅𝐞𝐞𝐥 𝐟𝐫𝐞𝐞 𝐭𝐨 𝐭𝐚𝐠 𝐭𝐡𝐞𝐦 𝐮𝐧𝐝𝐞𝐫 𝐭𝐡𝐢𝐬 𝐩𝐨𝐬𝐭. 📌 https://lnkd.in/eMRjA6Tr #ectd #fda #regulatorysubmissions #pharmaceutical #regulatoryoperations

💡✨Ready to unleash your regulatory powers like never before? Join us for an electrifying webinar featuring the one and only Raz Eliav, the ultimate CMC Development and Regulatory Affairs expert. 💥 Prepare to have your mind blown as we reveal the hidden secrets to optimizing your regulatory submissions and turbocharging your workflow using the mighty eQMS system. 🚀 🔑 Brace yourself for an arsenal of benefits: ✅ Unlock mind-boggling tips and tricks to capture project knowledge with finesse, even when dealing with more subcontractors than a supervillain's evil lair. ✅Say goodbye to submission struggles and hello to precision and efficiency. ✅Crush the challenges of managing product and process knowledge across organizations and obliterate those pesky information silos. ✅Unleash the full potential of the Quality Management System (QMS) and become a regulatory project management legend. 📆 Date: 21st September 2023 ⏰ Time: 16:00-17:30 CET Berlin. 🔗 Register here: https://rfr.bz/l6kgx6u Special thanks to our event sponsor, Qualio, the brilliant minds behind the state-of-the-art cloud eQMS. Without their superpowers, this webinar wouldn't be possible. 🙌🌟 #QualityAssurance #CMCDevelopment #eQMS #GMP #Pharma #Pharmaceutical #Pharmaceuticals #Quality #Pharmaceuticalmanufacturing

📚✨ What's in the Name… (Documentation Edition) 📝🔍 Swipe through to decode the alphabet soup of official paperwork— From IEC to MSDS, we're here to decode the jargon and shed light on the essential documents that keep the pharma industry running smoothly. So, are you ready to level up your documentation game? . . . . . . #documentation #edition #documentations #msds #adc #noc #iec #pharmaceuticalindustry #pharmaindustry #pharmaindustrynews #medicine #pharmacy #pharma #thelotusbiotech #tlb

The FDA's open data files hold the key to unlocking the secrets of successful cold chain validation for your BLA submission. Discover how to navigate this data and gain valuable insights into FDA expectations, real-world temperature excursion considerations, and building a robust validation plan that ensures regulatory compliance. https://hubs.la/Q02zMnmc0 #coldchain #pharma #FDA #validation #ModalitySolutions

📢 Exciting News for the Life Science Community! We would like to share the upcoming release of the significantly expanded ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data - Good eClinical Practice! We are also proud to share that our colleague, Thana Subramanian, was a contributing author to the DCT annex. Why You Need This Guide? 🔹 Stay Compliant: Get up-to-date information on regulatory requirements. 🔹 Improve Efficiency: Discover best practices for streamlined validation processes. 🔹 Leverage Technology: Gain insights on new technologies to enhance trial integrity and data reliability. 🔹 Protect Participants: Employ a robust validation framework to safeguard trial participants. Don’t miss out on this invaluable resource for all GCP computerized systems' stakeholders. Stay tuned for more details and be among the first to benefit from this update! More info 👉 https://lnkd.in/giKbkA9y #LifeSciences #ClinicalTrials #GAMP #GCPCompliance #eClinical #RegulatoryCompliance #Validation #Pharmaceuticals #Biotechnology #HealthcareInnovation #ISPE #DataIntegrity #PLG #Integrity

BioPhorum Regulatory CMC welcomes Regeneron. We are delighted you are joining this group. Following a discovery program of work with heads of regulatory CMC, we identified some key topics of collaboration, that are helping us shape the final program. You can view the Phorum here https://okt.to/VCNJGj Join the Regulatory CMC group here https://okt.to/lg9P48 The regulatory environment is challenging and complex, despite global efforts to harmonize and simplify. The quality of the product does not depend on where the patient is, but this is not reflected in the regulatory ecosystem today. This can have a significant impact on regulatory approvals, time to market, and ultimately, patient access to innovative new treatments and therapies. #biophorum #regulatory #NewMember #biopharmacueticals