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| Webinar: Mastering the Complexities of Gene Therapy Document Writing | Gene therapy is complex—and so is writing about it. From viral vectors to cell types, every element demands deep understanding. Safety reporting adds further complexity: is an adverse event from chemotherapy, a procedure, or the gene therapy itself? These challenges require a thoughtful, flexible approach to document strategy and execution. Explore common hurdles and practical solutions for gene therapy document writing and submissions. |
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FOCUS ON REGULATORY & COMPLIANCE |
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By Irwin Hirsh, Q-Specialists AB | Lean offers manufacturers a host of efficiencies, but they don't all work for GMP. Here are some ideas for translating best practices for a highly-regulated industry. | |
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| Measuring And Monitoring Environmental Surface Residues | Webinar | Contec, Inc. | Explore techniques like visual inspection and TOC sampling to assess surface residues as well as discover the benefits and challenges of these practical methods to achieve effective residue validation. |
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| Regulatory Compliance In Clinical Research | Article | Novotech | Understand the critical aspects of regulatory compliance, and gain insights into how you can safeguard participant rights and ensuring the integrity of clinical research. |
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| The Ex-Regulator's View On Small Surface Contamination Control | Article | By Matt Cokely and Philip Rose, Ecolab Life Sciences | Effective small surface disinfection in cleanrooms requires adherence to detailed procedures and best practices. Learn about the critical steps, techniques, and validation needed to ensure product safety. |
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| Discover the future of iPSC-based therapies in this free Cell & Gene Live digital event. Experts will share insights on emerging applications, regulatory challenges, gene editing advancements, and key safety considerations in scalable iPSC manufacturing. Don't miss this opportunity to hear from leaders at the forefront of regenerative medicine. Supported by Invetech. |
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REGULATORY & COMPLIANCE SOLUTIONS |
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