ISO IDMP REQUIREMENTS

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/[email protected]/bookings/

Alternatively, you can contact us at: [email protected]

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Are you prepared for the regulatory changes coming in 2025? These changes could significantly impact your budget and resources, especially at an executive level. We’re

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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.

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Related news and events

NEWS | EMA updates during the Q3 System Demo

NEWS | Important Update: Product User Interface (PUI) & Electronic Application Form (eAF) Enhancements

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About

Team

Partners

CSR

AI Ethic Code

Careers

ISO IDMP REQUIREMENTS

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

Search

Filter by category

Related news and events

NEWS | EMA updates during the Q3 System Demo

NEWS | Important Update: Product User Interface (PUI) & Electronic Application Form (eAF) Enhancements

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