NEW | CTIS EMA Subject Matter Expert

February 20, 2024

At Asphalion we are very proud to announce that Nuria Garcia Pazos has been appointed EMA Subject Matter Expert (SME) for Clinical Trials Information System (CTIS)!

She is the latest addition to Asphalion’ s already existing SMEs, Laura Casals for Regulatory Procedure Management and Daniel Langa for eCTD 4.0.

An industry Subject Matter Expert has knowledge and expertise of a specific business solution or product that he/she can provide to a Product Team when requested (usually) by the Product Owner.

You can have a look at the current SMEs here: https://bit.ly/46Gne4s

Congratulations, Nuria, on this great achievement!

Contact us for all your Regulatory Affairs and Safety needs! Our experts can help you in all your projects: [email protected]

Also, you can schedule a free 30-minutes meeting here: SCHEDULE A MEETING

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NEWS | EMA New Fee Regulation effective January 2025

The European Medicines Agency (EMA) charges fees for the services it provides. As of 1 January 2025, EMA’s fees are governed by Regulation (EU) 2024/568. This is known as the ‘New fee regulation’. Current rules apply still apply until 31 December 2024.

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