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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

  • Bertrand Le Bourgeois Dipl.Ing., MSc
  • Founder and CEO
  • PharMarketing, France
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  • Julianne Hull BSc MSc
  • Consultant and Trainer in Pharma Industry
  • United Kingdom
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Course description

This interactive training will provide essential insights to the key requirements for Data Integrity and Data Protection.

The key principles of EU General Data Protection Regulation (GDPR) dedicated to the data privacy project team: it is the first step in the compliance journey to ensuring GDPR. The regulation, the definition of personal data, sensitive data, a vulnerable person, and of critical processes per GDPR. Discover what pseudonymised personal data is and when personal data can be considered fully anonymised. Learn the countries and people impacted by GDPR, the new deadlines, penalties, and a simple implementation approach. Understand the interplay of GDPR with existing regulations and guidelines from the life sciences sector (GxPs).

The key principles of Data Integrity: organisations taking responsibility for the systems they use and the data they generate; paper or electronic. That organisations understand the criticality of their data and any inherent risk to integrity. Key goal is that organisations can stand over the integrity of their Clinical Trial data and thus any decisions they make based on these data.

In association with

phetairos_logo

Phetairos is an associate community of world-class biopharmaceutical consultants and subject matter experts. We help our clients by using our combined experience and industry best practice to design and deliver innovative solutions across the entire biopharmaceutical value chain. Our independent “hands-on” approach helps our clients to release the full potential of their products, organisations & people. We are dedicated to consistent delivery of successful client outcomes through collaboration, quality assurance, flexibility, cultural alignment, transparency and knowledge sharing. www.phetairos.com .

Key topics

Requirements to meet data integrity in Clinical Trials

GDPR principles

Definition of ‘raw data’

Data Protection Officer

Protocol deviations and data breach

Understand data governance measures

Commonalities and differences between GxP and GDPR

Key takeaways

Understand: ALCOA+ A: attributable L: legible C: contemporaneous O: original A: accurate and Complete.

Recognise data governance measures expected to ensure that data is complete, consistent, enduring and available throughout the lifecycle.

Minimum requirements to meet data integrity in Clinical Trials.

GDPR principles to apply to personal data your company is processing.

Understand the difference between Data Controller and Data Processor.

Describe the role of the Data Protection Officer.

Appropriate action in case of protocol deviation, and of a data breach.

What mandatory documents are required and tool(s) to support.

Comprehend what clients, vendors, employees, healthcare professionals, patients and Data Protection Authorities might require for GDPR.

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