Pharmaceutical Online

Planning a new manufacturing facility or upgrading an existing site? Don’t miss Pharmaceutical Online Live on April 16th where our expert panel will dive into facility design & validation—covering clean rooms, HVAC, utilities, and more. Registration is free thanks to the support of AES Clean Technology. Reserve your spot (free): https://lnkd.in/egqGMurr 🎙️ Expert Speakers: - Erich Bozenhardt, PE - Assoc. Director Process Engineering, Xeno / Regenerative Medicine, United Therapeutics Corporation - Herman Bozenhardt - President, Herman Bozenhardt - Frederic Grossfeld - Registered Architect and Architectural Department Manager, Jacobs #pharmaceuticalmanufacturing #pharmaceuticalvalidation #drugmanufacturing #facilitydesign #cleanroom

This webinar focuses on FDA regulations for platform technologies in drug-device combinations, like prefilled syringes and autoinjectors. It covers strategies for bridging formulation changes, leveraging existing data for submissions, and de-risking innovation. Key takeaways include optimizing regulatory strategies, ensuring compliance, and balancing speed-to-market with FDA expectations for successful approval. #Kymanox #regulatory #platformdevices

📢 Virtual Event: Optimizing Human Factors Testing: Engaging End-Users in Medical Device Development Engaging users isn't just compliance—it's about building better, safer healthcare. Join us for a discussion on the significance of human factors in the development of medical devices by illustrating how important it is to incorporate the end users in the device development process. Key takeaways: 1. Create a comfortable testing space: Ditch the anxiety and embrace realistic simulations! 2. Optimize the process: Maximize valuable time with HCPs and patients. 3. Show the impact: Let participants see how their feedback shapes device design. Reserve your spot (free!): https://lnkd.in/eGg-q6UD 📅 March 11, 2025 🕚 11:00 am ET West Pharmaceutical Services #medicaldevices #medicaldevicedevelopment #hcp

Pharmaceutical labeling ensures safe medication use, emphasizing accuracy, readability, and regulatory compliance. In this webinar you’ll learn how factors like printing methods, inspection criteria, and automation levels influence the choice of labeling machinery. HERMA Labeling Machines, with 40,000+ global installations, specializes in vial, bottle, syringe, autoinjector, carton, and tamper-evident labeling, offering solutions to meet space constraints and automation needs. #Herma #labeling #pharmaceutical

How High Drug Load Nanocrystalline Tablets Lower Pill Burden Join this virtual event, where our subject matter experts showcase the development of high drug load nanocrystal based tablets. They will prove that nanocrystals can match the pharmacokinetic performance of ASDs while reducing the pill size and overall pill burden. Nanoforming drug candidates can enable innovators to launch single pill medicines to: - Maintain a market exclusivity for much longer periods - Enable value added generics that can enter the market early due to a unique IP position and significant patient benefit. 🎙️ Expert Speakers: - Dr Tamás Solymosi, Lead Scientist, Nanoform - Dr Martti Kaasalainen, Senior Formulation Scientist, Nanoform Save your spot: https://lnkd.in/e2Jp_P5D Date: March 12, 2025, at 11:00 am ET #asds #singlepill #patientcentricity #nanocrystalline #pillsize

Optimizing Human Factors Testing: Engaging End-Users in Medical Device Development How do you ensure medical devices are truly safe and effective? By putting users first! 🥇 In this upcoming virtual event, we will discuss the significance of human factors in the development of medical devices by illustrating how important it is to incorporate the end users in the device development process.  Expert Speaker: 🎙️ Anastasia Diamond, Ph.D., Principal, Regulatory Affairs & Human Factors Join us for a deep dive into human factors testing. Save your spot (FREE!): https://lnkd.in/es2TbbYJ Date: March 11, 2025, at 11:00 am ET https://lnkd.in/es2TbbYJ West Pharmaceutical Services #medicaldevicedevelopment #humanfactorstesting #hcp

FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. This guidance is expected to help ensure that AI models used to support regulatory decision-making are sufficiently credible for the COU. To address this challenge, a set of planned activities to ensure the model’s performance, called life cycle maintenance, is required. In this article, Susan Shockey with Clarkston Consulting, addresses three main topics intended for this draft guidance. https://lnkd.in/exEUWg-r #fda #drugdevelopment #aimodel #drugproduct #biologicalproducts

Save the date to explore the importance of effective cleaning in pharmaceutical and cosmetic manufacturing. Learn how optimizing cleaning chemistry, selecting the right detergents, and refining process parameters can prevent cross-contamination, improve efficiency, and ensure product quality. Discover key insights from real-world case studies on enhancing compliance, reducing costs, and meeting regulatory standards for safe, high-quality production. #Alconox #crosscontamination #pharmaceuticalmanufacturing

For Gilead, Sustainability Is More Than A PR Effort “Sustainability” is a shiny word. But beyond compelling headlines and inspiring conference sessions, what does sustainability actually mean for the biopharma industry? What does it look like in practice? How can advanced therapy manufacturing become more sustainable? Tyler Menichiello digs into these questions with Joydeep Ganguly, the chief sustainability officer and SVP of operations at Gilead Sciences. To Ganguly, sustainability is more than lofty goals and corporate jargon. It’s an attitude. Learn more about Gilead’s cultural focus on sustainability and how it influences everything from R&D to manufacturing. 🔗 https://lnkd.in/eAxtg6ia #sustainability #biopharma #biomanufacturing #pharmaceuticalmanufacturing