Garuda Therapeutics’ Post

We look forward to the Centre for Applied Pharmacokinetic Research (CAPKR) as an active participant in the newly established Quantitative Medicine Centre of Excellence (QM CoE) at the FDA, aligning with its goals 🎯to facilitate and coordinate the continuous evolution of quantitative medicine for drug development and regulatory decision-making. We agree #drugdevelopment is a multifaceted, complex, high-risk endeavour process involving a range of scientific, financial💰 and regulatory challenges. To this end, the recently published The AAPS Journal report: https://lnkd.in/gDTit5d2 which Prof.Amin Rostami-Hodjegan is an author of, highlights how Model Master File (MMF) can improve the efficiency with which evidence from modeling and simulation (M&S) can facilitate drug product development 💊 and support regulatory acceptability. The MMF is a framework for sharing and reusing models, akin to drug master files. By facilitating model sharing, standardization, and regulatory consistency, MMFs play a crucial role in improving efficiency and ensuring the timely delivery of safe and effective medicines ✅ to the public. Prof.Amin Rostami-Hodjegan will be attending the https://lnkd.in/gAiEJ9gk FDA and Center for Research on Complex Generics (CRCG) Workshop on May 2‐3, 2024, to engage model developers, industry, and FDA, where he will be speaking and chairing discussions on crucial aspects of an MMF such as; identifying the types of products/areas that may benefit from MMF applications, exploring MMF types and how it can enhance regulatory approval supported by M&S approaches 💡 The Centre for Applied Pharmacokinetic Research (CAPKR) at The University of Manchester is proud of our MoU 🤝with FDA and will continue our collaborations as Model Informed Drug Development takes more central role in future regulatory decisions 🙌🏽 #DrugDevelopment #RegulatoryAffairs #QuantitativeMedicine #MMF #FDAWorkshop #CAPKRContributions #CCRG #FDA #UniversityofManchester #CAPKR #modeling #simulation

🤝 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

This should be a great step towards accelerating the regulatory approval process for some of the most innovative and needed therapies in development right now - great to see progress continue to be made. #progress #regulatoryaffairs #fda #quantitativemedicine

#artificialintelligence, #machinelearning and other uses of #quantitativemedicine hold considerable promise for #drugdevelopment. For #rarediseases in particular, these approaches can help mitigate the challenges of developing drugs for limited patient populations and help unlock the full granularity of available data sources. Excited to see FDA embracing this topic by establishing a new Center of Excellence!

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive:

In this issue of the New Medicines, Novel Insights newsletter, we outline 4 actions sponsors should take for a smooth transition to EU-CTR. 🚀 Be aware of accelerated timelines. 📚 Understand dossier requirements and plan for updated content. 🌠 Take a future-focused approach to in-progress trials. 💥 Maintain momentum during application review. Take a deeper dive: