Formerly based in Connecticut where he worked with Bristol-Myers Squibb, Robert Hindes, MD, has served Trek Therapeutics as chief medical officer since 2014. In this role, Robert Hindes, MD, directly supervises Trek’s pharmacovigilance (PV) program.
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The World Health Organization’s Pharmacovigilance Program
1. The World Health Organization’s
Pharmacovigilance Program
Robert Hindes MD
2. Introduction
• Formerly based in Connecticut where he worked with
Bristol-Myers Squibb, Robert Hindes, MD, has served Trek
Therapeutics as chief medical officer since 2014. In this
role, Robert Hindes, MD, directly supervises Trek’s
pharmacovigilance (PV) program.
The World Health Organization (WHO) defines PV as any
activities or scientific works that relate to the assessment,
understanding, detection, and prevention of drug-related
adverse effects and problems. The concept came to
prominence in the wake of the thalidomide disaster of the
early 1960s, during which many pregnant women who took
the drug thalidomide gave birth to children with birth
defects.
3. Pharmacovigilance Program
• WHO’s response was the creation of the Programme for
International Drug Monitoring, which maintained 134
member countries at the end of 2010. The initiative’s aim is
to improve patient safety and care through the rigorous
examination of medicines. Further, it provides fair and
reliable information relating to the assessment of medicine
risk-benefit profiles.
Membership is open to WHO member states that have
implemented an individual case safety reports (ICSRs)
collection program. Applicants must provide WHO with a
minimum sample of 20 ICSRs alongside the formal
application.