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Tag: Life sciences

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  • Decentralised Trials
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Contributed: Trials and tribulations – the new world of decentralized trials – Mobihealth News

EXPERT NOTES: CONTEXT:  Decentralized Clinical Trials IMPACT:  Enabling technology for ‘Decentralized Clinical Trials’ a.k.a ‘Virtual Trials’ Time Taken = 2 mins QUOTES FROM SOURCE: 1. “As mentioned earlier, COVID-19 has 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
Category:
  • Pharmacovigilance (post-approval)
  • Recently Released

News: Human medicines: highlights of 2020

Quick Notes: *Within the report the “conditional marketing authorisations” and “monitoring in real-life” are the “go to” section to see what the post-authorisation obligations were and what the EMA is Continue Reading

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

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