Global Medicines Program

April 3, 2014

Promoting Active Surveillance Pharmacovigilance in India

Andy Stergachis traveled to Mumbai, India in March to emphasize the need for give a talk titled, “Active Surveillance in Pharmacovigilance” at a Drug Information Association India sponsored conference March 21-22, 2014. The conference, which focused on pharmacovigilance, was targeted to professionals in a range of disciplines from risk management and regulatory affairs, to clinical and regulatory personnel.DIA Mumbai

His talk titled, “Active Surveillance in Pharmacovigilance” Stergachis said that drugs and vaccines are reaching unprecedented numbers of people in low- and middle-income countries and that the products have tremendous potential to save lives and reduce suffering. However, many countries in which these products will be used do not have the capacity to effectively monitor their post-marketing safety. He emphasized the need for active surveillance.

Five reasons for active surveillance:

  1. Enables follow-up on safety signals;
  2. Allows for investigation of newer products that have a limited real-world safety profile;
  3. Provides ability to calculate rates of risk factors for adverse events;
  4. Can complement other pharmacovigilance methods; and
  5. Enables monitoring of pregnancy outcomes following any prenatal drug exposures.

View full presentation.