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Real-World Evidence for Regulatory Decision-Making: Guidance, Methods, and Case Studies

Learn how to evaluate, design, and apply real-world evidence studies that support regulatory decisions across the drug development lifecycle.

関連イベント

オンライン

Review the CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) with this on-demand course.

会員価格: 非会員価格:
Virtual price: $1,800.00 $2,125.00

オンライン

Complete this On-Demand Training Course to learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

会員価格: 非会員価格:
Virtual price: $3,545.00 $3,870.00

オンライン

Explore FDA's approach to regulation of combination products, the processes to streamline development of single entity, and aligning requirements between drugs and devices.

会員価格: 非会員価格:
Virtual price: $750.00 $1,075.00

オンライン

Discover the essential principles, regulatory insights, and compliance strategies for medical devices and combination products in this comprehensive on-demand training course.

会員価格: 非会員価格:
Virtual price: $750.00 $1,075.00

オンライン

Gain a better understanding of the global regulatory landscape for companion diagnostics, from key terminology and IVD classifications to the requirements guiding clinical studies and commercial products in the US and EU.

会員価格: 非会員価格:
Virtual price: $750.00 $1,075.00

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