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New Drug Product Development and Lifecycle Management

Gain a better understanding of how companies structure efforts to improve the odds of successful development and minimize risks associated with shepherding a new drug candidate through the process.


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関連イベント

  • 対面受講

    DIA 2020 Global Annual Meeting

    Registration Now Open!

  • Online
  • 対面受講

    Navigating Chemistry, Manufacturing, and Controls Through the Drug Development Process

    This interactive course will demonstrate CMC sections of regulatory submissions, the FDA inspection process, and how to avoid or minimize 483s (noncompliance) using real-life scenarios.

  • 対面受講

    Regulatory Affairs for Combination Products

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

  • 対面受講

    Regulatory Affairs: The IND, NDA, and Post-Marketing

    Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

  • 対面受講

    Regulatory Affairs: The IND, NDA, and Post-Marketing

    Learn about FDA regulations and expectations for the content, submission and review of INDs/NDAs, and the importance of regulatory strategy.

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