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ISO IDMP REQUIREMENTS

Beginning 15th September 2021, FDA will enforce the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.

Beginning 15th September 2021, FDA will enforce the Technical Rejection Criteria (TRC) for Study Data by CDER and CBER.
June 17, 2021

Have you started looking into ISO IDMP requirements? The European Implementation Guidance version 2.0 (EU IG v2.0) was already published last February, and version 2.1 is expected to be published by the end of this month.

The vast amount of data required for IDMP compliance poses a significant challenge to organizations. If you need any help understanding the guidance or any support with GAP analysis or data remediation, do not hesitate to schedule a meeting with our experts.

https://outlook.office365.com/owa/calendar/AsphalionSL@asphalion.onmicrosoft.com/bookings/

Alternatively, you can contact us at: info@asphalion.com

 

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VIDEO | IDMP pills – Public Report

Welcome to Asphalion’s IDMP pills! We are creating short videos explaining specific Data Management concepts, and today we are explaining how to access the Public

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