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Hot Topic: Do you know the regulatory expectations for vendor-hosted systems?

Course Date: November 16, 2018
Type of Course: Hot Topic
Course Trainer: Lead by Nadia Petiot
Location of Course: Online
Learning Objectives:

To keep up to date and to hear the viewpoints of different members regarding the hot topic being discussed.

Who is the Course Suitable For?

ACDM Members who would like to join an open discussion concerning a Hot Topic in Data Management.

Outline Course Content

EDC requires immense IT expertise and a sophisticated IT infrastructure to ensure security, data integrity, & business continuity for sometimes thousands of authorized users: high bandwidth, 24/7 availability, help desk, all required IT security measurements, back-up, recovery plan …

Many organisations in our industry do not have the kind of expertise that is expected in terms of IT infrastructure and maintenance of their EDC systems. In these precarious times of data hacking and insecurity, more and more companies no longer feel comfortable having patient data on their own servers. Hence why more and more data management functions are seeking to use external providers.

However, data managers who become involved in choosing vendor products (including hosting), do they really know how to evaluate and assess them properly? Do they know the criteria and regulatory expectations of such systems?

Why not come and join us to discuss the different aspects of this up and coming key topic covering:

  • CDM responsibilities
  • System set-up
  • System maintenance
  • Data back-up
  • Recovery plan
  • Change control
  • Help desk
  • IT infrastructure requirements
  • Required SOPs

Led by Nadia Petiot from Focus Data Science who is experienced in data management and IT, she has seen an increasing need for Data Managers to have a solid understanding of the EDC systems used for their studies. Nadia believes the Data Manager should not be solely focused on the CDM processes but should also have within their repertoire, the key elements required to ensure security and continuous availability of EDC systems.

Price (Member)  £0 (+VAT)
Price (Non-Member)  £50 (+VAT)
Link for Booking:  click here

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