FOI - Regulatory Inspections of IT vendors from EMA Member States
Dear European Medicines Agency,
Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, I am requesting documents which contain the following information:
I would like to request under the FOI legislation the following information:
The number of regulatory inspections performed on behalf of the EMA by Member States, conducted within the last 5 years aimed at IT companies/ service providers serving the pharmaceutical industry particularly:
Providing electronic data capture (EDC) services
Electronic patient outcome services ePRO/ eRT
Electronic document management systems EDMS
Randomisation software
Pharmacovigilance databases
Pharmacovigilance software supporting GVP – e.g. visualisation software, AI software for case triage etc
Quality management software eQMS
For the categories above please could you also provide:
The type pf organisation inspected
The outcome of the inspection e.g. number of critical/ major/ other observations
The categories of those observations
A redacted summary of the observations
The dates of inspection of those companies
The length of the inspection
Whether the inspection was remote or in person
I would request all information to be sent to this email address electronically.
Many thanks in advance for any information you can supply on the topics noted above. If there is any additional information needed please do not hesitate to contact me
Yours faithfully,
Matt Jones
Your message to [EMA request email] couldn't be delivered.
info wasn't found at ema.europa.eu.
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Original Message Details
Created Date: 10/22/2024 10:37:24 AM
Sender Address: [FOI #15133 email]
Recipient [EMA request email]
Address:
Subject: access to documents request - FOI - Regulatory Inspections
of IT vendors from EMA Member States
Error Details
Error: 554 5.4.14 Hop count exceeded - possible mail loop ATTR34
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