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Tag: Public health

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Category:
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  • Real World Research (RWR)
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EMA to USE EMA Software for Real World Data

Comments – Part of the EMA’s continued commitment to RWE in support of medicinal product utilisation. When you see regulators investing in infrastructure like this, you know they are serious Continue Reading

Posted On : February 16, 2021 Published By : Mark Lorkowski
Data sharing
Category:
  • Real World Research (RWR)
  • Recently Released

Human experimentation oversight committee wants to approve Israel-Pfizer data-sharing deal – CTech

Quick Notes: CONTEXT:  RWD, RWE, Pfizer, Isaeli Government, Data Transparency, Real-World Epidemiological Evidence Collaboration Agreement IMPACT:  Sharing of Real-World Epidemiological Evidence to improve understanding of impact of COVID-19 vaccination Time Continue Reading

Posted On : January 29, 2021 Published By : stuart.mccully
Category:
  • Recently Released
  • RWE - Real World Evidence

Real-world evidence of cabozantinib in patients with metastatic renal cell carcinoma: Results from the CABOREAL Early Access Program – MD Linx

EXPERT NOTES: CONTEXT:  Peer Reviewed Data, RWE of Effectiveness of Cabozantinib IMPACT:  In the largest real-world study to date, cabozantinib was effective in unselected, heavily pretreated patients with mRCC. Initiation Continue Reading

Posted On : January 29, 2021 Published By : stuart.mccully
Category:
  • Real World Research (RWR)
  • Recently Released
  • Regulatory
  • RWE - Real World Evidence
  • RWR & Regulators

Japan to use data from outside clinical trials in drug approvals – Nikkei Asia

Quick Notes: CONTEXT:  Japan, Real-World Data IMPACT:  Acceptability of RWD in Regulatory Submissions Time to Read = 2 mins Quotes from Source: 1. “TOKYO — Japan’s health ministry will issue Continue Reading

Posted On : January 29, 2021 Published By : stuart.mccully

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