今日、臨床薬理情報は医薬品添付文書の50％以上を占めています。不完全な臨床薬理学開発プログラムは、審査期間中にスポンサーに重大な問題を引き起こしたり、販売申請の承認可否に影響を与える可能性があります。製造販売承認申請の効率的な臨床薬理学審査には、開発計画の早期かつ思慮深い検討、必要な臨床試験の適時実施、モデルを活かした医薬品開発（MIDD）アプローチによる利用可能な臨床データの最大化、そして全情報の正確な伝達が求められます。
As former FDA and EMA regulators, the Certara Clinical Pharmacology Regulatory Strategy Team has extensive understanding of the requirements for fit-for-purpose clinical pharmacology drug development programs. The objective of this webinar is to review the clinical pharmacology-related regulatory hurdles across regions that may lead to review issues or impact approvability of marketing applications and discuss strategies to mitigate these.
The Certara team will discuss:
- How overly minimalistic clinical pharmacology documentation can jeopardize your drug’s approvability.
- Regulatory perspectives on gaps in clinical pharmacology knowledge and how those impact risk-benefit assessments
- Mitigation strategies to achieve a streamlined clinical pharmacology strategic plan.
