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FDA submission data requirements – Impact on Regulatory Operations

April 20 @ 10:00 - 11:00 UTC+0

Webinar Host:

Ted Hanebach, RAC - Director, Regulatory Operations, Mapi Group

Webinar Description:

In the recently published document titled Technical Rejection Criteria for Study Data, the FDA states that Study Data Standards are required in clinical and nonclinical studies that start after December 17, 2016 and are to be submitted in NDA/BLA/ANDA submissions, and after December 17, 2017 for the studies to be submitted to commercial INDs.

In the same document, the FDA also warns that if standardization recommendation is not followed, sponsors may face a technical rejection of their submissions. Although, bigger companies have been filing datasets packages prepared according to the CDISC standards for several years, for smaller and mid-sized companies, the novelty and the rapid evolution of these standards creates significant process challenges.

During this webinar, our regulatory expert will review the above information and explore common issues faced by the regulatory submission groups at smaller and mid-sized companies, and provide advice on how to organize dataset packages to avoid technical rejections.

Key discussion points:

• FDA updates to study data requirements
• Case study – how to avoid submission delays due to incomplete or incorrect study data
• Required components
• Study data formats, and
• Organization of study data within the submission
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April 20
10:00 - 11:00
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