Non-interventional studies

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Across
  1. 4. The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
  2. 7. The legal basis of Pharmacovigilance with No. 2001/84/EC.
  3. 8. MAH should do this 2 weeks after the first acceptance of the investigator´s article.
  4. 9. If it is one of the primary objectives of a NIS than this study undertakes the obligations from the Module 8.
  5. 10. It is a document that should be reviewed by QPPV/her delegate and submitted to CA and Agency before the start of the study.
Down
  1. 1. A product that does not have it, is not allowed to take part in NIS.
  2. 2. A trial is non-interventional when this is prescribed in the usual manner in accordance with SmPC.
  3. 3. A punishment imposed for non-compliance.
  4. 5. This should be done by MAH before the start of a PASS on the web page of the EU PAS Register.
  5. 6. In the SOP COB-01 stands that there is a local and a corporate...