Confirmatory Studies
コースについて
The primary purpose of clinical trials is to determine therapeutic benefit. Confirmatory studies further evaluate the effectiveness and safety of the drugs based on the results of the exploratory study, providing sufficient evidence for the approval of new drug applications. Having a deeper understanding of confirmatory studies is important to develop and implement an efficient clinical development plan.
This module introduces the value of these confirmatory trials in the lifecycle of clinical trials and shows how to formulate a holistic clinical development strategy that gives special consideration to confirmatory studies.
Workshop Objective
- Learn the key concepts of confirmatory research
- Understand the impact of confirmatory studies on late-stage clinical development strategy
Workshop Outline
- Core knowledge of confirmatory research
- Regulatory requirements
- Late-stage clinical development strategy
- Integrating confirmatory research in overall clinical development plan (CDP)
- Manage late-stage clinical research according to the target product profile (TPP) and CDP
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。
