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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VIDEO | IDMP Pills PMS Quality Issues

September 2, 2024

Welcome to Asphalion’s IDMP pills! We have created short videos about specific Data Management concepts, and today we are solving PMS quality issues you may

NEWS | Important Update for Marketing Authorization Holders (MAHs) in Support of the European Shortages Monitoring Platform (ESMP)

August 2, 2024

As part of the ongoing efforts to enhance transparency and monitoring of medicine shortages in Europe, the ESMP has outlined crucial steps that must be

VIDEO | IDMP Pills PMS & ESMP

July 17, 2024

Welcome to Asphalion’s IDMP pills! We are creating short videos talking about specific Data Management concepts, and today we are explaining the link between PMS

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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

VIDEO | IDMP Pills PMS Quality Issues

NEWS | Important Update for Marketing Authorization Holders (MAHs) in Support of the European Shortages Monitoring Platform (ESMP)

VIDEO | IDMP Pills PMS & ESMP

About

Team

Partners

CSR

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

VIDEO | IDMP Pills PMS Quality Issues

NEWS | Important Update for Marketing Authorization Holders (MAHs) in Support of the European Shortages Monitoring Platform (ESMP)

VIDEO | IDMP Pills PMS & ESMP

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