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Eriko Yamazaki

Principal Inspector of the Office of Non-clinical and Clinical Compliance 1 Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Eriko Yamazaki is a principal inspector of the Office of Non-clinical and Clinical Compliance 1 at Pharmaceuticals and Medical Devices Agency (PMDA). She serves for GCP inspection of clinical trials of medicinal product and international communication. She is also member of the ICH E6(R3) Expert Working Group representing Ministry of Health, Labour and Welfare (MHLW)/PMDA.

Her previous work experience includes review of new drugs applications in the Office of New Drug I between 2013-2019 and coordination of international programs at Office of International Programs between 2009-2013. In 2009, she joined PMDA after graduating with a master’s degree in biological science.

See Eriko Yamazaki at this event

  • Day 4 Friday 6 December

Advancing clinical trials: The impact of E6(R3) guideline

Session objectives:

  • Comprehend E6(R3) Guideline Revisions: key updates in E6(R3) and their significance for enhancing clinical trial practices and aligning with international standards.
  • Analyze Regulatory Preparations: how different regulatory authorities are preparing for the implementation of E6(R3).
  • Explore Data Integration: Consider the impact of E6(R3) on the use of Real-World Data (RWD) and Real-World Evidence (RWE), including the associated challenges and opportunities.

Speakers