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

 

Search News & Events

  • Filter by category

Share

Related news and events

EVENT | EMA PMS Info Day

EMA is holding a new public event with the purpose to provide a comprehensive understanding of Product Management Service (PMS) and its implications on other EMA digital services with the objective to introduce the core concepts of PMS, ensuring that all attendees have the chance to understand its implementation.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting