Non-interventional studies

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Across
  1. 5. LSO has a .... to register a NIS at CPV
  2. 7. It is a document that should be developed by the local committee before the start of the study.
  3. 8. If this is one of the primary objectives of a NIS, then such study undertakes the obligations from the Module 8.
  4. 9. In the SOP COB-01 stands that there is a local and a corporate...
  5. 10. The legal basis of Pharmacovigilance with No. 2010/84.
Down
  1. 1. MAH should do this 2 weeks after acceptance of the investigator´s report.
  2. 2. This should be done by MAH before the start of a PASS on the web page of the EU PAS Register
  3. 3. The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
  4. 4. When this is prescribed in the usual manner in accordance with SmPC the study is non-interventional
  5. 6. A punishment for non-compliance