GCSG - Global Clinical Supplies Group’s Post

Our Head of Clinical Marion Mays is speaking at CDISC #TMF Interchange in Berlin this week!! Hoping she sends us some awesome pictures 👀 😍 If you're there, be sure to attend her #training on #inspectionreadiness! #tmf #trialmasterfile #clinical #clinicaloperations #conferences #lifesciences #drugdevelopment #pharma #medtech #biotech #meddevice #fdaapproval #regulatoryaffairs

Hear from industry experts at the 13th Annual Clinical Trial Supply New England 2024 Conference. There’s never been a better time to hear directly from the FDA, providing invaluable insights and updates on regulatory requirements. This is a standalone event in that it caters specifically to the supply chain needs of this sector. 📅9th-10th April 2024 📍The Westin Waltham Boston, MA, USA Reserve your place by registering using code HAMK: https://shorturl.at/clCOT #CTSNewEngland #ClinicalTrials #Healthcare #Pharma #biotechnology #DecentralisedTrials

Set of very nice and useful tools for clinical research

Excited to share that I'll be speaking at the upcoming CompLaw Pharma conference on December 3rd! Our panel will be discussing Art. 102 and recent updates. Looking forward to engaging with fellow colleagues and sharing insights on the latest developments in our industry. Come and join us! #Pharma @Informa @competitionlaw

🔊Hear from industry experts at the 13th Annual Clinical Trial Supply New England 2024 Conference. There’s never been a better time to hear directly from the FDA, providing invaluable insights and updates on regulatory requirements. This is a standalone event in that it caters specifically to the supply chain needs of this sector. 📅9th-10th April 2024 📍The Westin Waltham Boston, MA, USA Reserve your place by registering using code HAMK:  https://shorturl.at/clCOT #CTSNewEngland #ClinicalTrials #Healthcare #Pharma #biotechnology #DecentralisedTrials

Last day to take advantage of early bird registration for RECON 2025! 𝐑𝐞𝐠𝐢𝐬𝐭𝐞𝐫 𝐭𝐨𝐝𝐚𝐲!🎉 ➡ https://lnkd.in/gE6WZtuj 🔎 Explore the Agenda: https://lnkd.in/girYwv7j Our speaker lineup includes luminaries from the FDA, industry leaders, and academia. Over the course of the two-day conference, we will delve into: 1. 𝐁𝐢𝐨𝐦𝐚𝐫𝐤𝐞𝐫 𝐭𝐨 𝐄𝐧𝐝𝐩𝐨𝐢𝐧𝐭 𝐓𝐫𝐚𝐧𝐬𝐥𝐚𝐭𝐢𝐨𝐧 - Establishing surrogate endpoints. 2. 𝐆𝐥𝐨𝐛𝐚𝐥 𝐑𝐞𝐠𝐮𝐥𝐚𝐭𝐨𝐫𝐲 𝐇𝐚𝐫𝐦𝐨𝐧𝐢𝐳𝐚𝐭𝐢𝐨𝐧 - Towards a streamlined global regulatory assessment. 3. 𝐏𝐫𝐨𝐣𝐞𝐜𝐭 𝐎𝐩𝐭𝐢𝐦𝐮𝐬 - R&D strategies, practicality, and collaboration between FDA and sponsors. 4. 𝐃𝐢𝐯𝐞𝐫𝐬𝐢𝐭𝐲 𝐢𝐧 𝐂𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐓𝐫𝐢𝐚𝐥𝐬 - Strategies and implications for enhancing clinical trial diversity. Spread the word among your colleagues- we can't wait to welcome you all there! #RECON #UniversityOfMarylandBaltimore #DrugDevelopment #Pharma #BioTech #FDA #ProjectOptimus #ClinicalTrials #RegulatoryStrategy #Biomarkers #Endpoints #RegulatoryHarmonization #VivproCorp #MorePowerToYou

📈 Quarterly Report LTR Pharma has today released its Quarterly Activities Report and Appendix 4C Quarterly Cash Flow report for the quarter ended 31 March 2024. Key highlights from this period include: ✅ Pivotal clinical study of SPONTAN® fully recruited and completed dosing of all participants. ✅ SPONTAN achieved key manufacturing validation and first commercial batch production. ✅ SPONTAN is designed to be a world-first, fast-acting, on-demand Nasal Spray treatment for Erectile Dysfunction (ED). . LTR Pharma Chairman, Lee Rodne, said: "We are pleased to share that LTR Pharma has made significant strides towards bringing SPONTAN to market this quarter. We completed the dosing phase of the pivotal study and met critical FDA requirements for manufacturing validation. We remain on track with a strong cash position to achieve our milestones and revolutionise the global erectile dysfunction treatment landscape.” Read today’s ASX release here 👉 https://lnkd.in/gRbh9zNn $LTP #LTRPharma #ASX #menshealth #innovation #pharma #biotech #erectiledysfunction 

If you’re new to using #PBBM, check out this recently published journal article that recaps key points from the recent workshop “Physiologically Based Biopharmaceutics Models (PBBM) Best Practices for Drug Product Quality: Regulatory and Industry Perspectives.” It offers case studies from regulatory authorities, frameworks for credibility assessment, and strategies to address barriers such as model validation and the establishment of safe spaces and failure edges in drug product development. https://lnkd.in/gngWJDEw

Transitioning from R&D to commercial success in biopharma - especially in Europe - is challenging. Our latest whitepaper, based on extensive research and 4,500 data points, reveals the seven key strategies for a successful first drug launch. Learn how to leverage unmet medical needs for optimal pricing and positioning. Download now! skp.link/hw10 #SimonKucher #Biopharma #FirstDrugLaunch #CommercialExcellence #BetterMarketAccess

Exciting progress is happening in psychedelic medicine. PharmAla Biotech Inc. (MDMA.CSE) has become the backbone of much of this when it comes to supplying GMP MDMA to research institutions and approved practitioners/patients. To stay updated - follow our account! #Biotech #Pharma #MDMA