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 ProjectInquiries@pistoiaalliance.org.
| TIME | SESSION |
| 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 |
Ready to Get Involved?
There has never been a more important time to collaborate to innovate as an industry! If you would like to find out more about the benefits of Pistoia Alliance membership and how you can get involved with all the different initiatives we run, please send an email to Membership@PistoiaAlliance.org.