Cell and Gene Therapy

About the course

As the cell and gene therapy (CGT) industry matures, more products are being released with a much higher frequency. Global pharmaceutical giants have also accessed the market in recent years, with nearly all the top 20 pharmaceutical competitors in Europe and the United States having made their way to CGT through mergers & acquisitions or cooperation. CGT has become a new frontier for the clinical research industry.

At the same time, CGT has met with many challenges in technology, R&D, clinical trials, industrialization, and regulations. Any problems that occur at any given stage in clinical research and development may affect the success of the final product.

Workshop Objective

  • Understand the entire process of new drug development as well as the key considerations and the impact of each stage
  • Acquire the special considerations on CGT (DNA-BLA) from CMC and clinical development perspective

Workshop Outline

  • Learn how to communicate with national regulatory bodies and apply for expedited programs
  • Case study and experience sharing on clinical research and development of CGT
Program | Global Clinical Development Strategy Workshop Series

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We develop tailored, meaningful and effective education and training programs to meet the increasing demand for professionals and executives in the biopharmaceutical industry. To learn more about our programs and customized training options, or request a free proposal, contact us to discuss your needs and desired goals.

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