Servicios y soluciones previos a la operación- ENG2018-06-07T23:16:46+00:00

Services and solutions before being

established the Pharmacovigilance and Technosurveillance Unit

Services and solutions before being established the Pharmacovigilance and Technosurveillance Unit

Strategies for the implementation of the Pharmacovigilance and Technosurveillance Unit.

Established improvement areas and a work plan. Level of mature for the Pharmacovigilance and Technosurveillance Unit of the client.

Strategies for the implementation and operation of the plan, in order to cumply with the NOM-220-SSA1-2016 and NOM-240-SSA1-2012.

Strategies for the implementation and operation of the plan

Stablish the critical route for the;

  • Implementation of the Pharmacovigilance and Technosurviellance Unit.
  • Implementation of the SOP Manual and SOP.
  • Development of the RMP, PSUR and Technosurviellance Reports, with prioritizing by deadline and categorization of the drugs and medical devices.

Pharmacovigilance and Technosurveillance Unit Implementation

The implementation of the Pharmacovigilance and Technosurveillance Unit it is according to the clients’ needs:

  • Development of the SOP Manual and SOP.
  • Recommendations for the notifications of Individual Case Safety Rereport and adverse incidents.
  • Define timelines to elaborate PSUR, RMP Technosurvielance reports and pharmacovigilance and Technosurviellance best practices training, management of SOP, Individual Case Safety Rereports and adverse incidents, etc.