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Grand Hilton Seoul

Sep 06, 2019 8:00 AM - Sep 06, 2019 7:00 PM

201-1, Hongeun-dong, Seodaemun-gu, Seoul 120-710, Korea, Republic of

DIA- NIFDS Pharmacovigilance Workshop : Best Practices in Pharmacovigilance

Highlights & Features

  • DSURs and PBRER writing: Aspects of Benefit – Risk Assessment
  • Signal Detection Method and evaluation from Regulatory Perspective
  • Signal detection methodology in real practices - Industry Experience
  • Recent changes in PMS and utilization of RWD/RWE in Japan PMS
  • Use of RWD/RWE in PV/PMS area
  • CCSI & CCDS development in real practice
  • Introduction to elabeling

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