コースについて

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.

ワークショップ 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
プログラム| Global Clinical Development Strategy Workshop Series

今日から始めましょう

私たちは、バイオ医薬品業界の専門家や幹部に対する高まる需要を満たすために、調整された、意味のある、効果的な教育およびトレーニングプログラムを開発します。当社のプログラムとカスタマイズされたトレーニングオプションの詳細を確認したり、無料の提案をリクエストしたりするには、お客様のニーズと希望する目標についてお問い合わせください。

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