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Online Live Training Features

All sessions of this unique course online

Live interaction options between the delegates and trainer

Available via mobile, tablet or laptop

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Meet the training leaders

  • Mark Poulton
  • Former GCP Inspector at MHRA, Executive Director
  • Poulton Quality Solutions, United Kingdom
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  • Willie Muehlhausen
  • Digital Innovator, Managing Director/Founder
  • Muehlhausen Consulting, Ireland
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Course description

With the increasing complexity of today’s clinical trials, as well as the speed of technology innovation, the 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 online live & learn, how a quality department can actively enable digital innovation in clinical trials & ensure the highest regulatory compliance at the same time.

Key topics

IRT managed under GCP regulation

ePRO requirements, audit targets & inspection observations

eConsent strategy & key considerations for compliance

EDM systems best practices

ELM systems quality compliance

Remote auditing

eTMF inspection readiness

Providers of systems – issues to be aware of

Audit trails of systems

Benefits of attending

Get critical insights into electronic systems used in clinical trials

Understand the interpretation of FDA & EMA guidelines related to electronic systems in clinical trials

Learn how to implement new electronic systems in a compliant way

Gain insights into BYOD use in a GCP context

Explore pros and cons of virtual trials and usage of AI/ML in clinical trials

Gain clarification on requirements & audit targets related to ePRO systems

Explore quality data requirements for EDC systems

Learn about the essential documents, technology & other requirements for eTMF

Get examples on IRT compliance best practices

Explore requirements on data ownership, metadata & structured data in electronic systems

Work on electronic data issues

Understand how to handle eConsent requirements & issues

Gain key considerations for audit trail of systems

Learn how to overcome the main issues with the providers of systems

Ticket

Delegate Fee

from 1396 € Buy

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