Member Roundtable: Validation and Qualification of Computerized Systems Used in CT


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Time: October 7, 4 PM BST / 11 AM EDT / 8 AM PDT


The European Medicines Agency has issued a notice (7th April 2020) to sponsors of a clinical study that could be interpreted to mean that the sponsor must have full visibility on the specificity and testing documentation for cloud-based applications used in pharmacovigilance and GxP processes.


During a first roundtable discussion, some Pistoia Alliance pharma members involved in IT Quality Assurance and Compliance anticipated that vendors of cloud-based systems may not be prepared to provide such documentation and as such this provides a challenge to the sponsors of clinical studies.


For this second roundtable discussion, our guest speakers will give some perspectives on the key aspects that EMA GCP inspectors are looking for and we will discuss some opportunities to identify and establish industry-wide best practices for sponsors to facilitate EMA GCP inspections.


For information on how to register, please email


16:00 Welcome & Intro
Summary & outcomes from the previous roundtable discussion
Anca Ciobanu, Pistoia Alliance
16:10 Where is the risk?
Bob McDowall, Consultant
16:20 How can the sponsors best facilitate EMA GCP inspections
Ib Alstrup, GxP IT Medicines Inspector, Lægemiddelstyrelsen (Danish Medicines Agency)
16:30 Interactive Question and Answer Session
17:00 Close


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