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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.

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在线

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

会员价: 非会员价:
Virtual price: $1,800.00 $2,125.00

在线

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.

会员价: 非会员价:
Virtual price: $3,545.00 $3,870.00

在线

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

会员价: 非会员价:
Virtual price: $750.00 $1,075.00

在线

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

会员价: 非会员价:
Virtual price: $750.00 $1,075.00

在线

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.

会员价: 非会员价:
Virtual price: $750.00 $1,075.00

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