Adverse Event Management
Dr. Chirag Trivedi
Affiliate Pharmacovigilance Head
Group sanofi-aventis
Presentation Contents
zDefinitions
zPrinciples of Pharmacovigilance
zProcesses in Pharmacovigilance
zRoles of Sponsor, Investigator and
Ethics Committee in monitoring safety
zSuspension of Trials due to safety
issues
Pharmacovigilance
The science and activities relating
to the detection, assessment,
understanding and prevention of
adverse effects or any other drug
related problems
[WHO definition]
Players in Monitoring Drug Safety
Drug Safety
Patients
Regulatory
Agency
Ethics
Committee
Investigator
Drug safety
monitoring
board (DSMB)
Sponsor
Interpretation of safety data
depends upon the interpreter’s
particular perspective in assessing
the safety data
zFor Practicing Clinicians
zFor Epidemiologists
z Adverse reactions are usually viewed as
an indication of medicine’s toxicity
z They may have a number of beneficial
aspects
z Indication that the medicine is absorbed in
adequate amounts
z Titration of dosages against their magnitude
z An adverse event for patients using a
medication for one indication may reveal a
novel indication that may be used for other
patients
z Predictable adverse events – may or may
not depend upon the administered dose
z Intrinsic toxicity of the medicine at a target
organ
z Unpredictable adverse events
z Idiosyncratic reactions that are sporadic and
non-reproducible
zHypersensitivity reactions
zMetabolic idiosyncratic reactions
zReactions based on auto-immune mechanisms
Levels of Adverse Events
z Single patient
z One or more adverse reactions which may occur on
more than one occasion in a single patient
z Single clinical trial
z Consideration of one or more adverse reactions that
occur in a single trial
z Single, multiple, or all the patients enrolled
z Multiple trials of a single medicine
z Consideration of one or more adverse reactions
experienced in multiple trials
Categories of Adverse events
z Measured in numerical and objective terms -
z Clinical laboratory abno