LORENZ Life Sciences Group’s Post

Ready for the final day of RAPS US Conference 2024? We sure are! 🚀 If you're looking for expert guidance on regulatory affairs in life sciences, stop by booth 539 to connect with our team. Antonio, Pieter, and Jens are eager to share insights and help tackle your regulatory challenges. See you there! 👋 #RAPSConvergence #LifeSciences #RegulatoryAffairs

Introducing Our New Series: Your Questions. Expert Answers. 💡 Curious about the clinical research world or our services? We’re launching a new #QandA section to address your most common questions! Kicking it off, Martin Schäfer, our Senior Regulatory Affairs Manager, begins by discussing post-market clinical follow-up (PMCF). In this first post, he explains: 🔹 The purpose of PMCF 🔹 Why pre-market tests don’t show all risks 🔹 PMCF alternatives 🔹 Global challenges in non-interventional studies Got more questions? We’ve got the answers! Drop your questions in the comments below, and we’ll cover them in future posts! 💬 #ClinicalResearch #PMCF #MedicalDevices #PostMarket #QuestionsAndAnswers #RegulatoryAffairs #YourQuestionsExpertAnswers #HealthTech

Day 2 of #BreakthroughRegulatory is in the books 📷 LifeSphere Regulatory took center stage as we heard from customers and ArisGlobal experts alike about the value, impact and latest developments of LifeSphere Regulatory products. What a way to close out a jam-packed two-day session here in Lisbon! #regulatoryoperations #regulatory #lifesciences #drugsafety

➡ The CIRS - Centre for Innovation in Regulatory Science recently published a study that “aimed to better understand the provision of #regulatory review documents and reports – what type of documents are requested, how often and how they are being used for risk-based decision making (e.g. #Reliance).” ❔ Interested in learning more? 🖱 Click here for the full report: https://lnkd.in/e-JVPbkp

To all those attending the Regulatory Affairs Professionals Society (RAPS) Global Regulatory Strategy Conference in Maryland 5th – 7th March, we hope you’re enjoying the discussions and the networking opportunities. We look forward to hearing some of the insights.  Contact Psephos to speak to our award winning regulatory team at info@psephos.com   #RAPS #medtech #regulatorystrategy #regulatoryaffairs

Register for the upcoming Regulatory Affairs Professionals Society (RAPS) Convergence 2024! Registration link: https://lnkd.in/gibC3w8P 📅 Date: September, 17-19, 2024 📍Location: Long Beach, California, USA Why attend? RAPS Convergence is the largest and most recognized annual gathering of global regulatory affairs professionals. Convergence brings together representatives of industry, regulatory bodies, research, academia, and clinical organizations that are directly involved in managing the regulatory process and aligning science, regulation, and business strategy.

Monitoring the regulatory landscape is critical to your program’s success. #ExpertiseInAction: Rho expert Casey Steadman, PhD, Regulatory Scientist, sheds light on recent regulatory guidance in a new blog post. To better understand the FDA’s updated guidance on confirmatory evidence, read the blog here https://lnkd.in/eM78hYbN #RegulatoryStrategy #FDAGuidance #RegulatoryGuidance

Discussion Forum For Pharma Quality Events, Regulatoy Actions... Just click the link. True that navigating for the right guidelines through Google search is bewildering with each search throwing out hundreds of links. Check out Guidelines page @https://lnkd.in/dJJ56EzT which list the most relevant regulatory guidelines classified topic wise

🤝 𝐌𝐞𝐞𝐭 𝐎𝐮𝐫 𝐄𝐱𝐩𝐞𝐫𝐭𝐬 𝐅𝐚𝐜𝐞 𝐭𝐨 𝐅𝐚𝐜𝐞 - 𝐔𝐩𝐜𝐨𝐦𝐢𝐧𝐠 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞 𝐀𝐭𝐭𝐞𝐧𝐝𝐚𝐧𝐜𝐞 Celegence is thrilled to announce our participation in the Q1 Productions 6𝐭𝐡 𝐀𝐧𝐧𝐮𝐚𝐥 𝐋𝐢𝐟𝐞 𝐒𝐜𝐢𝐞𝐧𝐜𝐞 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 & 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐲 𝐂𝐨𝐧𝐟𝐞𝐫𝐞𝐧𝐜𝐞, happening on April 10-11th in Baltimore, MD. This prestigious event gathers global intelligence, strategy, policy, and legal experts to exchange best practices and insights on the challenges faced by #regulatory teams in the #lifesciences industry. 📅 Join us as our Head of Regulatory Affairs, Marloes van Bruggen - van der Geer, takes part in a compelling panel discussion titled "𝐏𝐫𝐚𝐜𝐭𝐢𝐜𝐚𝐥 𝐒𝐭𝐫𝐚𝐭𝐞𝐠𝐢𝐞𝐬 𝐭𝐨 𝐁𝐮𝐢𝐥𝐝 𝐚 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐈𝐧𝐭𝐞𝐥𝐥𝐢𝐠𝐞𝐧𝐜𝐞 𝐆𝐫𝐨𝐮𝐩 𝐟𝐫𝐨𝐦 𝐒𝐜𝐫𝐚𝐭𝐜𝐡" on Wednesday, April 10 at 9:30 AM. Don't miss this opportunity to learn from industry leaders and gain valuable insights into #regulatoryintelligence strategies! ➡ For more details about the conference and our participation, check out our news article: https://lnkd.in/eytNVEkS #biotech #healthcare #pharma #pharmaceuticals #compliance #regintel #regulatorycompliance #drugdevelopment #regulatoryrequirements #drugsafety #regulatoryaffairs

The changes and new approaches in ICH Q5A revision 2 can pose complex and scientific challenges for manufacturers. In the short term, companies need to fully understand how such data impacts their current portfolio while planning for long-term changes in product testing and validation strategies. Find out more in the latest blog in our Regulatory Navigator series, from the CMC experts in Parexel’s Regulatory Strategy team.