0A4F4F9BD490A749D5437F821CF06DF1
External Circular No. 600-2006-16: National Reporting Serious Adverse Events
https://paginaweb.invima.gov.co/images/pdf/tecnovigilancia/buenas_practicas/normatividad/Circular-600-1081-16-Reporte-de-Eventos-adversos-serios-Nacionales-Febrero2016.pdf
http://leaux.net/URLS/ConvertAPI Text Files/A58D931EA96354A18E19F7269D032AC3.en.txt
Examining the file media/Synopses/A58D931EA96354A18E19F7269D032AC3.html:
This file was generated: 2020-07-15 04:30:25
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 1 |
Health / Drug Usage
Searching for indicator drug:
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p.(None): ALL BY
p.(None): NEW COUNTRY
p.(None): PAZ E Ç UI DA D E D UC A C I Ó N
p.(None): EXTERNAL CIRCULAR
p.(None): FROM TO:
p.(None): DIRECTION OF MEDICINES AND BIOLOGICAL PRODUCTS
p.(None): CONTRACT SPONSORS / RESEARCH ORGANIZATIONS RESPONSIBLE FOR THE REPORT OF
p.(None): NATIONAL SERIOUS ADVERSE EVENTS ASSOCIATED WITH DRUG SAFETY IN
p.(None): INVESTIGATION WITH HUMAN BEINGS
p.(None): SUBJECT: REPORT OF NATIONAL SERIOUS ADVERSE EVENTS
p.(None): DATE: February 18, 2016
p.(None): In order to advance in the optimization of procedures related to clinical research protocols before the
p.(None): group of Good Clinical Practices of the Directorate of Medicines and Biological Products; considering the
p.(None): volume of information submitted with the individual report of adverse events in clinical investigation, and
p.(None): taking into account the "Zero paper" policy, as well as Law 1437 of 2011, art 53 et seq and Directive No. 4 of
p.(None): 2012; the entity offers the possibility of filing information related to adverse events in
p.(None): clinical research, through the format provided on the web, which can be accessed from the browser
p.(None): Google Chrome using the link you will find in the FORMAT DILIGENCIATION GUIDE
p.(None): REPORT OF ADVERSE EVENTS IN INVESTIGATION PROTOCOLS, arranged in the
p.(None): INVIMA website through the Good Clinical Practices site.
p.(None): For the maintenance of confidentiality and information security, each of the reporters is asked to
p.(None): has assigned a personal and non-transferable password, which must be registered at the end of the loading of
p.(None): information in the format of each of the reported serious national adverse events.
p.(None): To obtain this key, you must do it through a personal presentation at the Medicines Department
p.(None): and Biological Products, with the professionals of the Group of Good Clinical Practices, at the Chapinero headquarters
p.(None): INVIMA.
p.(None): Attent nt
p.(None): LU FRANCO CHAPARRO
p.(None): Dir to of Medicines and Biological Products.
p.(None): Projected: 1. Ordoñez VoBo Legal: JP. Santaella. Archive: Circulars
p.(None): BPC Group "
p.(None): I / lsIiftlf0 I \ Í0fi0n0I of Yigil0kci0 4e gledif0lzlerltas and ÁIÍI lerlt0s - IN ¥ IMA
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| drug | Drug Usage |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | drug | 1 |