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Xtalks, Online
2024-02-21
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.
Keywords: Clinical Trials, FDA, Clinical Research, Clinical Data, Regulatory, Regulatory Affairs, Regulatory Compliance, FDA Guidance, Decentralized Clinical Trials, Electronic Data, Data Privacy, Patient Diversity
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Organized by:
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Xtalks |
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Invited Speakers:
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Marc Wartenberger, Director, Corporate QA & Compliance, CRIO
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Deadline for Abstracts:
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2024-02-21
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Registration:
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Free Registration
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E-mail:
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tristan@xtalks.com
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