Blue Matter’s Post

What are the key #SupplyChain costs associated with launching a #biopharma product in Europe? In this paper, we explore those costs & the "levers" that decision-makers can use to manage them. >> https://lnkd.in/eh3PfPia #pharmaceuticals #biotech

Whether transporting pharmaceuticals on a large or small scale, the pharma supply chain is about saving lives. A large shipment of quinine can protect an entire town from malaria while a shipment of a single organ can save one person. Partnerships and the human touch are key to transporting pharma.

Did you know that Anton Paar’s high precision instruments are used throughout the pharmaceutical industry for raw material quality control, final goods assay/checks, as well as for research and development? ⭕ Assess incoming goods and control final product quality with our Density Meters, Refractometers and Polarimeters. ⭕ Characterise and identify compounds with our FTIR and Raman spectrometers ⭕ Characterise nano- and microparticles in dispersions and solutions using light-scattering techniques with our Particle Analysers. ⭕ Investigate the flow behaviour and properties of your product with our innovative range of Rheometers, Viscometers, Penetration Testers and Zeta Potential Analysers. ⭕ Examine crystal structures with our X- Ray diffraction and small angle X-ray scattering systems ⭕ Use our Microwave Synthesis solutions that enable true scale-up from initial research to full production or Microwave sample preparation systems for AA & ICP analysis. Find out more: https://loom.ly/lla0lzQ #pharmaceutical #pharma #pharmaindustry #measurementinstruments

We are looking forward to attending this year's Making Pharmaceuticals exhibition, running from the 23rd to the 24th April at the Coventry Building Society Arena, Coventry. The event showcases the latest industry innovations and leading companies, including pharmaceutical manufacturers, distributors, drug developers and clinical research organisations. To arrange an appointment to discuss your regulatory requirements at the show, please contact us by visiting: https://loom.ly/QPMnyjc #Regulink #MAKINGPHARMAUK #regulatory #pharmaceuticals #regulation #clinicalstudies #drugdevelopment #pharma #clinicalresearch #clinicaltrials #compliance

As digital transformation gathers steam, the FDA is stressing the importance of rigorous documentation and compliance, making data integrity assurance a top priority. To fulfill regulatory requirements proactively, effective quality management now needs an integrated strategy that embraces innovation in addition to compliance. https://lnkd.in/eKNupgec

Register to attend a webinar, hosted by Current Consulting Group and Orange Tree, and learn about The Future of Drug Testing: What You Need to Know About Emerging Technologies, Drug Abuse Trends, and Complying with Evolving State Drug Testing Laws. Save your seat here: https://lnkd.in/gXi7BC3Z #Webinar #drugtesting #consulting #trends #BeCurrentToo

I was recently asked to compose a piece on regulatory updates impacting the Pharma industry across the last ten years in 400 words!! The article has just come out in this months Contract Pharma (https://lnkd.in/ehcEnSsc) Four hundred words was never going to be enough and the final edit maybe lack a few contextual nuances but hopefully it makes enough sense: "There have been multiple regulatory changes impacting EU GMP, including three chapter updates and six revised Annexes published in Eudralex, new GMP Guidance for ATMPs, implementation of 536/2014 (CTR), and one of the stars falling o the EU flag as the UK left the European Union. Keeping up to date has been a challenge these past ten years, and within these updates some have proven more diicult for the industry to adopt and implement than others. For example, updates to the Premises and Production chapters brought the need for toxicological assessments based on health-based exposure levels, and corresponding implementation where high potent drugs were manufactured. In many cases, this necessitated manufacturing reconfigurations or even facility remodeling to support contained/closed systems. Some of these updates were quite expansive. For one, the revision to Annex 1 for Sterile Products with granularity was nearly four times the length of its predecessor. There was strong resistance to call for Pre-Use Post Sterilization Integrity Testing (PUPSIT), with risk assessments often being deployed. Annex 1 defines stringent criteria concerning where risk assessments are possible, but in many cases, this is being flouted, leading to contentious debates regarding PUPSIT’s real-world benefits. The UK’s departure from the EU also impacted the industry, requiring supply chains to adapt to the new geographical borders; consequently, the post-Brexit UK is free to make its own laws and guidances concerning drug product manufacturing and regulation. Most recently we have seen the implementation of the Clinical Trial Regulation (536/2014), whereby all clinical trials within the EU must be registered with sponsors, per the transition from the soon-to-be defunct Clinical Trial Directive 2001/20/ EC to the new Regulation." Logon to Contract Pharma to read the full article

🧪 #FunFactFriday: Ever wonder about timelines? The entire drug development process can usually take 10 to 15 years, but #Phase1 trials are relatively swift, usually wrapping up in a few months. Expedient your early phase drug development process and save time on your next project. ⌛ 🔗 https://hubs.li/Q02GXqGn0 BioPharma Services Inc. specializes in #Phase1 clinical trials, bioavailability, #bioequivalence, First-in-Human and Human Abuse Potential Studies (#HAP). Let our world-renowned #Pharmacokinetics team execute your next clinical trial with confidence. . . . #clinicalresearch #clinicalstudies #clinicaltrials #bioanalsysis #cro #clinicaltrials #Biopharma #drugdevelopment #genericdrugs #biotech #pharmaceuticalindustry

As most countries kick-start the preparations for the last quarter following the well-earned Summer break, here is a list of readings I found useful during this festive season: - Empowering MSLs to be the kings of Pharma’s New Frontier - Achieving Success in Scientific Exchange - Turning DOLs into KOLs – a new way to nurture influence in pharma - Field Medical Impact Measurement: A Biopharma Consensus and finally, the future of medical affairs in 2030 You can find an executive summary of those articles at: www.mymedicalaffairs.com #actionableinsights #work #msl #msls #team #pharmaceutical #medicalaffairs #futureofhealthcare

Regulatory reliance is an important tool to strengthen regulatory capacity and make health systems more resilient. It is also useful for increasing the availability of medicinal products while focusing regulatory human resources on higher-risk activities. In Africa, more countries are ratifying the #AMATreaty to enable the operational implementation of the continental regulatory system that will benefit patients, regulators, industry, and healthcare systems in Africa.   During the #RegulatoryAffairs #NetworkingCocktail held on April 12, 2024 at Golden Tulip Hotel, Westlands, Dr. Angeline Achoka engaged biopharmaceutical professionals and industry stakeholders on the importance of #RegulatoryReliance and challenges faced by the biopharmaceutical industry in #HarmonizingProcedures. She strongly advocated for regulatory reliance in the continent and called for prompt management of challenges that will arise due to regulatory harmonization. Watch, Subscribe & Share: https://lnkd.in/d-pP2akr #RegualtoryHarmonization #RegulatorySystemsStrengthening