This knowledge is crucial as we think about the future of our project, particularly if we aim to move our gene therapy approach for cystic fibrosis closer to clinical trials and real-world applications. My participation in the GXP training has equipped me with the necessary tools to potentially guide our team through the complex regulatory landscape, ensuring our work remains aligned with industry standards and ready for the next steps in development.
One of the key speakers during the GXP course was Dr. Marcus Berger [LINK INtreview Beerger], whose expertise was invaluable to me and the entire team. After the course, I had the opportunity to ask Dr. Berger some questions, further deepening my understanding of the practical applications of GXP in research. The connection with Dr. Berger has been highly beneficial, as his insights helped shape key aspects of our project’s development and compliance with industry standards. His guidance will continue to be a valuable resource for our team moving forward.
Through this training, I feel better positioned to contribute to the team’s efforts, ensuring our project adheres to global safety and ethical guidelines. This experience has strengthened our approach and set a solid foundation for future progress, ensuring that our research, public engagement, and potential clinical applications continue to meet the highest regulatory standards. </p>],
type:"meta",
summary:"Kaya, a member of the iGEM Bielefeld 2024 team, completed an intensive one-week GXP (Good Practice) training, which covered Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP). The training provided valuable insights into maintaining high standards of quality, safety, and ethics throughout the research process. Kaya learned crucial skills, such as documenting research processes for reproducibility, creating standard operating procedures (SOPs), and conducting risk assessments using techniques like Failure Mode and Effects Analysis (FMEA). This knowledge is essential for advancing their cystic fibrosis gene therapy project toward clinical trials and ensuring compliance with regulatory standards. Dr. Marcus Berger, a key speaker in the course, provided additional guidance, offering valuable insights that will continue to benefit the team.",
