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Navigating the Regulatory Landscape in Clinical Trials in 2024

Abstract:

Staying current with regulatory changes is important when it comes to staying out of trouble with regulatory agencies, maintaining your reputation, and successfully conducting clinical trials. Join Marc Wartenberger, Director Corporate QA & Compliance at CRIO, for a review of new regulations, guidance, and decisions from 2023 that will impact clinical research. Highlights include:

  • New Part 11 guidance
  • FDA DCT guidance
  • FDA Patient Diversity guidance
  • EU-US Data Privacy Framework

The featured speaker will also provide insights into anticipated changes for 2024. Webinar participants will:

  • Review industry regulations and guidance on Decentralized Clinical Trials (DCT), Electronic Records & Signatures (Part 11), Patient Diversity, and EU-US Data Privacy Framework.
  • Formulate a plan to avoid regulatory repercussions by preparing for upcoming trial directives and changes that impact clinical research.
  • Identify strategies to prepare for regulatory changes by adapting your operations.

The webinar will include practical advice for how to stay compliant with real world examples from Marc’s experience. Join this webinar to explore pivotal regulatory updates affecting clinical research and proactive strategies.

Speaker:

Marc Wartenberger, Director, Corporate QA & Compliance, CRIO

As the Director of Security, Corporate QA and Compliance, Marc Wartenberger is leading the corporate security, quality and compliance initiatives at CRIO. Additionally, he is serving as CRIO’s Data Protection Officer. Prior to CRIO, Marc was leading the quality assurance efforts at snapIoT, now part of Labcorp Drug Development. Before snapIoT, Marc was a key member of the corporate compliance and QA group at Clinical Ink from 2012-2021 and served as its Data Protection Officer from 2018 to 2021.

 

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