Module 12 Presentations

Who can and should submit xEVMPD data, and how?

Who must submit data- and when?

• Sponsors of Clinical Trails – information on IMPs to the xEVMPD before submission of CTA in the EU • MAHs – legally required to submit information on new MAAs and to keep it up to date throughout the product lifecycle

Who is allowed to submit data?

At least 1 user from the MAH

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• Or the task can be delegated to a 3 rd party services provider

How do you do a submission?

Through EVWEB

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• Through an API (e.g., via RIM or another solution)

The Organisation for Professionals in Regulatory Affairs