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