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Meet the training leader

  • Mark Poulton
  • Former GCP Inspector at MHRA, Executive Director
  • Poulton Quality Solutions, United Kingdom
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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 the 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.

Key topics

eTMF inspection readiness

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

Providers of systems – issues to be aware of

Audit trails of systems

Future technologies – quality & compliance implications

Key takeaways

Get critical insights into electronic systems used in clinical trials

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

Familiarize yourself with ICH E6 & it's implications on electronic systems

Learn how to implement new electronic systems in a compliant way

Gain clarification on requirements & audit targets related ePRO systems

Explore quality data requirements for EDC systems

Practice developing an audit plan and risk analysis for EHR and ePRO audits

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

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

Get the examples on IRT compliance best practice

Explore requirements on data ownership, metadata & structured data of EMR systems

Understand how to handle eConsent requirements & issues

Explore EDM and ELM main pain points & how to overcome them

Gain key considerations for audit trail of systems

Special features

Led by a former GCP Inspector, MHRA, UK with 40 years of experience in the Pharmaceutical Research Industry

Interactive learning approaches

Tailored case studies

Workshop on electronic data issues

Workshop on risk analysis and audit plan for electronic systems

Individual case-by-case consultancy with the trainer

Comprehensive printed and digital course documentation

Certificate of completion issued by the trainer

Join us in Vienna

Besides being the capital and largest city in Austria, Vienna is also the cultural, political and economic centre of the country. Vienna host many international organizations and is considered to be one of the best places for innovation.

Ticket

Delegate Fee

from 2396 € Buy

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