Menu Close

Hot Topic Discussions

Hot Topics from ACDM

About ACDM Hot Topics

These are held online as ‘discussions’ focussing on a topic in Data Management. They are free for ACDM members (small fee for Non-Members).

A person is identified to lead each session, together with a Chair, they drive the discussion with those who join call. Sometimes the sessions are recorded and/or summarised and shared with ACDM members.

Ensuring Compliance and Data Integrity in eClinical Systems: Navigating EU Regulatory Frameworks and Best Practices

Date: July 24, 2024
Type: Hot Topic
Session Lead: Simone Ahrens-Mende from KLIFO GmbH
Location: Online 13:00 – 14:00 BST | 14:00 – 15:00 CET
Learning Objectives:
Who is this suitable for?

ACDM members and non-members who would like to join an open discussion concerning a Hot Topic in Data Management

Outline content

Join us for an insightful webinar presented by Simone Ahrens-Mende, Director of Data Management and Biostatistics at KLIFO, where we will explore the critical aspects of maintaining compliance and ensuring data integrity in eClinical systems. This presentation will guide you through:

  • Navigating EU Regulatory Frameworks: Gain a deep understanding of the regulatory landscape, including key guidelines such as FDA 21 CFR Part 11, ICH E6, GAMP 5, and GDPR, which shape the compliance requirements for eClinical systems.
  • Best Practices and Strategies: Learn effective strategies for balancing innovative technology with stringent regulatory demands. Discover best practices for implementing and maintaining eClinical systems to ensure data accuracy, security, and reliability throughout the clinical trial process.
  • Comprehensive Compliance Approach: Understand the entire lifecycle of eClinical systems from development and validation to decommissioning. The presentation will cover crucial topics such as change control management, validation processes, data integrity, and risk management.
  • Real-World Insights: Benefit from Simone’s extensive 23-year experience in clinical research and eClinical systems. Hear about her journey from pioneering the adoption of the first eCRF system to leading successful implementations of subsequent systems while adhering to complex regulatory frameworks.

Prepare to enhance your knowledge and skills in managing eClinical systems effectively, ensuring compliance, and safeguarding data integrity in an ever-evolving regulatory environment. Don’t miss this opportunity to stay ahead in the field of clinical research and data management.

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

Back to List >

By booking onto any ACDM event or training course you agree to be bound by the Terms and Conditions of Booking which can be read here: T&Cs