Good Clinical Practices and Pharmacovigilance

In the changing pharmaceutical industry, companies need constantly filing drug applications for both, new medicines and new markets for existing medicines.

This process has increased its complexity over time, involving multiple business areas and outsourcing some activities to Contract Research Organizations (CROs), often located in many different countries. The Pharmaceutical Industry should ensure that the requirements of Good Clinical Practice (GCP) are met at all times, as well as the correct management and statistical processing of the associated data.

On the other hand, once the medicine is in the market, it is necessary to have a Pharmacovigilance system to properly manage the adverse events detected, in order to effectively detect and evaluate all potential problems. The Pharmacovigilance system should have an adequate Quality Management System and organization, as well as well-established processes to ensure compliance with Good Pharmacovigilance Practices (GVP).

TDV’s sound experience in GCP and GVP, includes:

  • Implementation of Quality Systems in medical research departments, pharmacovigilance departments and CROs.
  • Internal audits and audits to CROs and Pharmacovigilance Managers worldwide
  • Audits of clinical trials and bioequivalence studies
  • Validation of software related to clinical data management, statistical calculations with clinical data and pharmacovigilance data management

 

For more information on Good Clinical Practice and Pharmacovigilance, please contact:

Sergi Arcas
sarcas@tdvct.com

 

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