Sunday, 28 February 2021

HPRA REGULATORY UPDATE- FEBRUARY 2021


The HPRA Regulatory Update is OUT so please have a quick look. This issue covers:
  1. Non-compliance trends 2020
  2. Update on Sap Processes:NTPS guidance and changes in the submission process as well as an alert on additional Project purposes changes.
  3. Administrative issues on submissions and requests to HPRA
  4. Final reminder on statistical returns submission and a word stressing that the submissions must include actual severity experienced by animals over prospective. This might require several entries (rows) in the returns document, please include them.
  5. CPD solutions and the expectation that researchers complete ETPLAS e-learning modules that can be found here https://etplas.eu
  6. ECVAM  and other replacement options updates in in vitro cellular and developmental Biology are very good resources worth dedicating your time.
  7. Other useful links on webinars, event, updates, wikis that makes this update a relevant and a very useful reading.

Complete update please check you LAPBRU-USERS library.

In this occasion, please focus your attention on the NTPS take home messages:
  • From 01.01.2021 all NTPS must be completed using a EC Excel template.
  • Since a EC draft guidance was not available, the SAP Team -HPRA generated a word document, currently available on their website.
  • The SAP Team -HPRA will transfer the information in the word documents of the projects already submitted to the EC Excel template.
  • The EC Excel template will be available mid-March 2021
  • From 12-4-21 all NTPs will need to be submitted in this template.

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