Digital Quality in Clinical Trials

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Course description

With the increasing complexity of today’s clinical trials, as well as the speed of technology innovation, unique issues have emerged especially in the area of clinical trials and the use of electronic systems. Understanding regulations – particularly the principles and intent of those regulations – and being able to apply them to new technology and processes in clinical trials, is critical to a company’s success. Novel approaches to safeguard data integrity and human subjects need to be considered.

This unique course provides a practical & in-depth understanding of electronic systems and technologies
used in clinical trials, and brings clarifications on global regulation, requirements, compliance & quality
concerns.

Join us in Vienna & learn, how a quality department can actively enable digital innovation in clinical trials &
ensure the highest regulatory compliance at the same time.

meet the training leaders
Mark Poulton
Executive Director, Former GCP Inspector at MHRA
Poulton Quality Solutions, UK
Willie Muehlhausen
Digital Innovator, Partner
SAFIRA Clinical Research, Ireland
training

Brochure

Reveal the full schedule of the training as well as key topics, course objectives, key takeaways, special features, and the trainer bio!

Digital Quality in Clinical Trials training by Fleming_Agenda Cover
Digital Quality in Clinical Trials training by Fleming_Agenda Sneak Peek
Digital Quality in Clinical Trials training by Fleming_Agenda Sneak Peek_1
key training

Topics

Global regulations for electronic systems in clinical trials & DCT projects

Digital revolution in clinical trials & GCP compliance

Remote auditing

eConsent strategy & key considerations for compliance

ePRO requirements, audit targets & inspection observations

EDC requirements & compliance

IRT managed under GCP regulation

EDM systems best practices

ELM systems quality compliance

eTMF inspection readiness

Providers of systems – issues to be aware of

Audit trails of systems

Benefits of attending

Registration

Training ticket

Delegate Fee
FROM
2196

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DOWNLOAD THE BROCHURE AND REVEAL THE FULL PROGRAM DETAILS

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