The document presents an overview of pharmacovigilance, focusing on the detection, assessment, understanding, and prevention of adverse effects related to medicinal products. It defines adverse events and drug reactions, categorizing them by severity and reporting responsibilities for investigators and sponsors in clinical research. Critical reporting timelines and procedures for serious adverse drug reactions are also outlined.

1. ADVERSE EVENT
REPORTING SYSTEM
Presented By:
Mr. Rajat Goyal
Assistant Professor
MMCP, MM(DU)

2. WHO definition of
pharmacovigilance
It is the science and activities relating to the detection, assessment,
understanding and prevention of adverse effects or any other
medicine related problem.
1] Detection
2] Assessment and understanding
3] Prevention of adverse effects
Pharmacovigilance

3. Reason forAdverse event
collection and reporting
• The most important responsibilities of investigator and sponsor in
clinical research studies.
• Protection of human subjects.
• Collection of clean and reproducible data.
• They need to analyze the data and determine Risk/benefits before
giving permission market.
ADVERSE EVENT:
Definition- Any unwanted medical occurrence in a patient or clinical
investigation subject administered a pharmaceutical product and which
does not necessarily to a casual relationship with this treatment. As per
ICH E2A

4. ADVERSE EVENT[AE]
• Any unfavorable and
unintended sign.
• Including an abnormal
laboratory finding
• Symptom
• Disease
UNWANTED EFFECTS
• Symptoms [headache,
nausea]
• Physical findings [BP,
lump, edema]
• Abnormal lab values
[increased liver enzymes,
decreased hemoglobin]
• Overdoses important to
define what% cut-off to
be taken as adverse
events.

5. Examples
Unfavorable deviation from baseline health, which
includes-
• Headache present at baseline was mild, now become severe.
• Worsening of conditions present at onset of the study.
Unfavorable deviation from baseline health, which
includes-
• Patient deterioration due to primary disease.
• BPH study-patient going into acute retention of urine.
• Antibiotic study: URTI progressing to lower respiratory tract
infection.

6. Adverse drug reaction [ADR]
In the pre-approval clinical experience:
Defined as all noxious and unintented responsed to a medicinal
product related to any dose should be considered adverse drug
reactions.
The phrase ‘ response to a medical products’ means that a casual
relationship between a medicinal product and an adverse event is
at least a reasonable possibility, i.e. relationship can’t be ruled
out.

7. CONTT..
UNEXPECTED ADVERSE DRUG REACTION:
An adverse reaction, the nature or severity of which is not
consistent with the applicable product information.
[E.g. Investigator’s brochure for an unapproved investigational
medicinal product]
SERIOUS ADVERSE DRUG REACTION:
• Results in death.
• Life-threatening
• Requires inpatient hospitalization or prolongation of existing.
• Hospitalization.
• Birth defect.

8. LIFE-THREATENING
• Any AE that places the patient or subject, in the view of the
investigator, at immediate risk of death from the reaction as it
occurred.
• Does not include a reaction that, had it occurred in a more
severe form, might have caused death.
• EXAMPLES-
1. Pacemaker failure
2. Gastrointestinal hemorrhage
3. Infusion pump failure
4. Excessive IV fluid dosing
5. Toxic drug levels

9. INTENSITY
• Severity of the Adverse Event [ WHO Classification ]
1.MILD: Awareness of sign, symptom, or event, but easily
tolerated.
2.MODERATE: Discomfort enough to cause interference with
usual activity and may warrant intervention.
3.SEVERE: Incapacitating with inability to do usual activities or
significantly affects clinical status, and warrants intervention
required.

10. EXAMPLES
• Dizziness, Patient feels the symptom, but can go on with
routine activities.
• Non Serious AE with Mild intensity.
• Myocardinal infraction.
• Affecting only 10% myocardium.
• Serious AE, with mild intensity, Headache.
• Causing a person to take leave, not able to work, needs
medication.
• Non Serious AE , with severe intensity.

11. REPORTING TIME FRAMES
• 1.REGULATORY 2.IRB/IEC 3.PARTICIPATING
INVESTIGATORS
• Serious Unexpected Fatal or Life-threatening unexpected
ADRs
• Fatal or life-threatening, unexpected ADRs occurring in
clinical investigations qualify for every rapid reporting.
• Regulatory agencies should be notified [e.g. By telephone ,
facsimile transmission, or in writing] as soon as possible but
no later than 7 calendar days after first knowledge by the
sponsor that a case qualifies, followed by within 8 additional
calendar days the complete report.
• This report should include an assessment of the importance
and implication of the findings including relevant previous
experience with the same or similar medicinal products.