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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 Jessica Cordes, senior consultant, Clinical Excellence GmbH | Understanding how the European Union's Directive 2004/23/EC interacts with GMP — and where its jurisdiction begins and ends — is essential for successful clinical trial planning, compliance, and execution. | |
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| Unveiling The Potential Of Psychedelic Therapies | Article | Avance Clinical | Leading experts highlight the transformative potential of the rapidly evolving field of psychedelic therapies and underscore the importance of rigorous clinical trials and regulatory compliance. |
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| Understanding Potency In Gene Therapy Development | White Paper | Bio-Rad Laboratories, Inc. | Explore the importance of understanding potency in cell and gene therapy (CGT) development and the challenges in developing potency assays for CGT products. |
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| Achieving EU GMP Annex 1 Compliance For Contamination Control | Article | By Dr. Ana Kuschel, West Pharmaceutical Services, Inc. | Gain insight into three areas that have been key in ensuring a robust contamination control strategy to help ensure compliance with the updated Annex 1 regulation: planning, people, and products. |
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| The ISCT 2025 Scientific Annual Meeting (May 7-10 in New Orleans) is the largest global gathering for KOLs and subject matter experts for driving the clinical translation of cell and gene therapies. The work presented at this conference spans regulatory affairs, workforce development and the entire development pathway from pre-clinical work to Phase 3 clinical trials, CGT product launch and market access. Register Today! |
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REGULATORY & COMPLIANCE SOLUTIONS |
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| Connect With Cell & Gene: |
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