MAIN5’s Post

✴ MAIN5 at the 17th GAMP D-A-CH Conference in Mannheim!  We are thrilled to announce that MAIN5 will be represented at the 17th GAMP D-A-CH Konferenz, in Mannheim, by our esteemed Managing Partner, Alexander T., and our Principal Consultants and #CSV #experts, Jens Marburg and Marko Lubura. On December 3rd and 4th CSV enthusiasts, practitioners and topic leaders from the industry come together and have the chance to connect, share experiences, listen to lectures and participate in discussion rounds about the future of the industry. We are proud that MAIN5 will be actively contributing to the discussions and initiatives shaping the future of the Life Sciences industry. This year, a special highlight is the MAIN5 Life Sciences Survey 2025, a unique initiative to gather perspectives on key industry topics and challenges, with results to be shared with the community. 👋 If you are also at the conference, feel free to engage with our colleagues. Let's talk about the Life-Sciences Industry, discuss challenges and opportunities in #CSV, and beyond. #GAMP #GAMP5 #Compliance #Quality #ComputerizedSystemValidation #MAIN5 #LifeSciences #GxP #QualityAssurance #Pharma #LifeSciences #RegulatoryCompliance #Validation

Dive into the heart of innovation at #DIAEurope2024! Explore eleven tracks that span the entire drug development lifecycle, including the CMC & Product Quality Track. Led by the experts Sofia Ribeiro (Bayer) and Matthew Popkin (GSK), this track explores the most recent developments in science, technology, and regulations impacting CMC and GMP related activities. Ready to be inspired? Watch the video below as Sofia shares insights into the current CMC landscape and why DIA Europe serves as the ultimate platform for fostering crucial discussions in this field. Hurry, there’s still time to secure your spot! Learn more here: https://bit.ly/3qDyjTV. #Conference #LifeSciences #CMC #RegulatoryAffairs

🏈As the dust settles on the Protocol Bowl, we reflect on the valuable insights gained from this event. Madeline Geday from Astellas Pharma alludes to the fact that written protocols do a terrible job of reflecting the complexities of study conduct. 💡At ProofPilot, we couldn't agree more. The frustrations and intricacies of deciphering these documents can feel like trying to find your way through a maze blindfolded. By showcasing the power of digital protocols to optimize trial conduct, we've paved the way for a future where complexity is made simple with automated workflows, so every research endeavor has the best chance of success. #ProofPilot #ClinicalTrials #ClinicalStudy #ClinicalTrialAutomation #ProtocolBowl

For my pharma network, you should check this learning opportunity out. Andrea and Byron really know their stuff (plus they are quite entertaining) and ICH Q14 is a hot topic right now. Looking to improve your analytical procedure development? Join us on Oct. 1 to learn how to leverage experimental design to optimize the new ICH Q14 guidelines. Gain insights from our industry experts, @Andrea Coombs & @Byron Wingerd. Reserve your spot today! ➡️ go.jmp/ICHweb #AnalyticalDevelopment #ICHQ14 #Pharma

Join us for the "Annex I: A Practical Perspective" course this September at NIBRT. This immersive one-day in-person training will dive into the latest impactful changes to Annex I for sterile medicinal drug product manufacturing. Date: 03 September 2024 Location: NIBRT, Dublin What You'll Learn: -High-level overview of Annex I in the regulatory environment -Hands-on experience in NIBRT’s pilot plant with the state-of-the-art fill finish line -Practical insights into PUPSIT, environmental monitoring in Grade A to B/C environments, and applying Annex I principles to drug product manufacturing. 💡 Key Topics: -Annex I updates and applications -PUPSIT: Implementation, risks, and challenges -Environmental Monitoring (EM) for Fill Finish: Set-up and considerations -Practical application of Annex I updates to manufacturing 👥 Who Should Attend: Ideal for companies or individuals looking to upskill their operations staff on the latest Annex I updates and their operational impact. Don't miss out on this chance to enrol. Register now: https://hubs.la/Q02JpLxx0 #Biopharma #Training #AnnexI #NIBRT #PharmaManufacturing #SterileManufacturing #Upskill #ProfessionalDevelopment

Listen to our Chief Digital Officer, Kwok Pang, discuss our digital strategy and how it will accelerated our insights and learnings and unlock our decentralized manufacturing ambition. info@adthera.bio   #cdmo #regenerativemedicine #digitalfirst #celltherapy #immunotherapy #innovation #processdevelopment #continousimprovement #gmp #clinicaltrials #atmp #advancedtherapies #personalizedmedicine #gxp #optimization #automation #bestinclass #rightfirsttime #celltherapymanufacturing #innovation #digital #partnerships #collaboration

Please come by and meet with us at the event! Find out why so many of the biggest pharma companies in the world are ditching their traditional LMS platforms and now using the Learn to Win platform to train their sales teams. #bestanalytics #bettertraining #betterresults #LearntoWin

Join our upcoming webinar: "FDA as a Development Partner: A New Approach to Product Review Meetings" webinar sponsored and moderated by FDAnews Webinars. 🗓️ Thursday, March 21, 2024 🕒 13:30 - 15:00 EDT Discover how to navigate product review meetings with the FDA as a development partner, not just an adversary. Gain insights from industry experts on successful interactions with sponsors and regulators to advance products through the development, submission, and approval process. Key Takeaways: ✅ Develop a gameplan for FDA meetings ✅ Value of preparation and rehearsal ✅ Understanding the product journey process ✅ Adherence to timelines for success Meet Your Presenters: 🎙️ Mark Lane, VP of Development Consulting and Scientific Affairs at PharmaLex 🎙️ Anna Perelka, Director of Regulatory Affairs U.S. at PharmaLex 🎙️ Patrick Larcier, Senior Director of Strategy Product Development Solutions, EU and U.S. at PharmaLex Don't miss this opportunity to learn best practices and ensure successful interactions with regulatory agencies. Register now! 🔗 https://lnkd.in/e_FKpkvE Book a meeting with our experts! https://lnkd.in/en99uyXz #FDA #ProductReviewMeetings #RegulatoryAffairs #Webinar #PharmaLex #FDAnews

What do you get when you attend a Veeva Systems Commercial Summit and our own Vice President of Partnerships JoJo Kalita reflects on her experiences in Madrid? You get a great blog about the how the future #LifeSciences is 🕶️ super bright .🕶️ Check it 👇 in the first comment. #Biopharma #Europe #IntelligentFieldExcellence

Happy Friday! Here's another unmissable session to look forward to at this year's IRT conference to round off your week (and remind you to book your ticket before savings end next Friday, September 13th)! Understanding Systems – Supply Chain User needs vs. IRT User Needs - What do actual end users want (including sponsors and sites). - What standardisation is required around systems and what does this look like? - Tech integration for different end users – needs and requirements. - How can we make systems user friendly to ensure that IRT and supply chain managers can work hand in hand to get the right product to the right patient? - IRT vs. RTSM. Speakers: Marc Lava, RTSM Product Owner at Johnson & Johnson Kerry Armstrong, Associate Director, PDCS Clinical Supply Management IRT Systems at Alexion Pharmaceuticals, Inc. John Maggard, PMP, Senior Manager, IRT Systems at AbbVie Manish Kumar, Senior Director, Software Development at Oracle Don't miss your opportunity to be part of the conversation and learn for the industry's best! 👉 Register today:  https://lnkd.in/egVzfzkF 📑 Download the agenda to learn more:   https://lnkd.in/e4sTM9qY #IRT2024 #InteractiveResponseTechnologies #IRT #RTSM #IXRS #ClinicalSupply #ClinicalSystems #ClinicalOperations #ClinicalResearch #Pharmaceuticals #Biotech