The AEMPS Clinical Trials Submission Teleportal

by Alta Tecnologia y Educación, S.L.Professional Training Solutions

• To learn how to submit correctly a telematic submission of Clinical Trial Applications in Spain with Human Medicines

To the Ethics Committees

To the National Authority (AEMPS)

following Administrative procedures Act 30/1992

What is this course about?

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1. Applicant submits CTA

3. IEC or NCA reviews applications and performs validation

2. AEMPS or CC-CEIC Master File Storage

AoR

GNAAuthorisation

Opinion

Includes Graphic representations of workflow

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‘STEP by STEP’ guidance along the course

Supported submission types:• Initial Submission• Pre-authorisation submission• Post-authorisation submission

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Points to consider for non-resident applicants

1. Digital signature is likely that cannot be used

2. Therefore, the menu option to be used to send the application is

Enviar Solicitud sin Certificado digital

3. Requires to post cover letter with return copy

4. Always check with your reference IEChow to submit every single application

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Alta Tecnología y Educación, S.L.

Professional Training SolutionsE-learning, in-company, multimedia and streaming

Music by AUDIONAUTIX

Featuring “Spanish Summer”

Full course at http://intl.atye.es/courses.html