Pregnancy is an unavoidable crucial topic while coming to patient safety. Before or after medicinal product administration as safety professionals we should always check the safety of consumers. This slide deck will explain in which circumstance we should refer to an ICSR for pregnant women and/or Baby

1. Mallikarjuna Mocharlla
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Pregnancy: Maternal and
Paternal Pregnancy Exposure

2. Maternal exposure
• When a woman
takes drugs/biologics(product).
• Why to be vigilant on that!
Changes can occur in the body and brain of her
baby causing long-term effects/congenital
syndromes and withdrawal symptoms.
Paternal exposure
• A paternal exposure is anything the father
of the baby is exposed to before
or during his partner's pregnancy
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4. Reports of pregnancy exposure (maternal and paternal) with or without an AE that contain the four
(4) minimum criteria for an ICSR are considered valid.
Entry Guidelines:
 Term to capture(RRT)
1. There are no circumstances when the term pregnancy is captured as an event:
A more specific term, such as drug exposure during pregnancy or drug exposure prior to pregnancy should
be selected.
2. For device contraceptive (non-systemic acting) products, the term drug exposure during pregnancy is
not used. Instead, terms specific to the product such as pregnancy with intrauterine device are used.
 In general, describe Caesarean section, a procedure, in the narrative and do not enter as
an event:
1. Report the underlying cause or reason for the Caesarean section as the reported event.
2. However, report Caesarean section as the event when it is the only information received.
3. Describe Elective Caesarean sections in the narrative only.
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5.  Case seriousness of events with pregnancy exposure
Serious
1. Drug/Maternal exposure during pregnancy
associated with SAE
2. Premature infant with or without an
additionalAE
3. Spontaneous abortion
4. Pregnancy on company drug/device
contraceptive:
5. Pregnancy on company drug/device
contraceptive while using another
company drug: Company drug/device
contraceptive is considered serious and
should be linked to the company drug ICSR
6. Fetal demise.
7. Elective abortion.
Non serious
1. Suspicion of pregnancy: (including suspicion
of pregnancy on company drug/device
contraceptive product).
2. Drug/Maternal exposure during pregnancy
associated with a non-seriousAE
3. Pregnancy in a partner(father case)
4. Drug/Maternal exposure during pregnancy
associated with noAE
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6.  company causality
Not related for the event of drug exposure during pregnancy for non-interventional ICSRs.
However, causality may be amended as needed based on medical judgement and in accordance with
relevant standard process
 Dechallenge / Rechallenge
drug exposure during pregnancy -- Not Applicable
 If the AE is a CongenitalAnomaly:
o Use the age or birth date of the baby or the date pregnancy is terminated.
o Enter information in the narrative if available as to the time during pregnancy where exposure
occurred.
o Enter the age of the baby on the Pregnancy screen of the maternal ICSR.
 For paternal exposure: select Biological Father Exposed to Drug on the Additional Info. sub-screen on
the Product Screen.
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8.  In the baby ICSR,
1. The dosage section of the Product screen applies to the parental dose: Capture the parent’s route of
administration in the data field “Parent’s route of admin.”
2. All dosage information, including indication, for the baby ICSR must contain the parent information (including
the parent’s concomitant medications).
3. Enter the baby’s route of administration in the route of admin data field and parent’s route of administration in
the parent’s route of admin data field.
 SpecialConsiderations for Indications:
1. Female partner of a male exposed to company product and becomes pregnant:The indication for the female
partner is as per the partner’s indication for use
2. For ICSRs in which the fetus was exposed during pregnancy, the indication should as per the maternal
indication of use, unless the exposure to the mother was via the father. In this case, the paternal indication
should be used.
3. If exposure to a company device product occurred prior to the pregnancy and the reporter attributes an AE in
the infant to that prior exposure, the maternal indication for product use should be selected as the indication.
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9. SpecialConsiderations for Route of Administration:
1. Female partner of a male exposed to company product and becomes pregnant:
Route of administration is Unknown female partner.
 SpecialConsideration for Dosing:
Female partner of a male exposed to company product and becomes pregnant:
In the female partner ICSR, enter male partner’s dosing in “Additional Drug Information” in the Product Additional Info
sub-screen.
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15. Important fields in ARISg database
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• The pregnancy related data fields should be entered in the maternal ICSR.
• Gestation period:Auto‐calculated as follows,Gestation period = (Earliest AE Onset date ‐ (LMP
date + 14 days))/7). If this is manually entered, then select the Manual checkbox.
• Outcome: Enter even if unknown/unspecified for all pregnancy maternal ICSRs.
• Para:Total number of live births the patient experienced.
• Gravida:Total number of pregnancies the patient experienced including current.
• LMP date: date of last menstrual period
• Expected delivery date: Expected delivery date of current pregnancy.
• Product tab
• Enter the age of the fetus at the time of initial drug exposure in Gestation Period on Product >
Additional Information section, if provided.
• Enter the method of exposure of the drug to the child.

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• Area of Focus: Baby ICSR
1. Complete for parent as provided including parent history.
2. The Dosage section of the Product screen applies to the Parental dose.
3. All dosage information, including indication must contain the parent information
(including the parent’s concomitant medications).
4. If relating to paternal exposure, select ‘Biological Father Exposed to Drug’ on the
Additional Info. Screen
5. Enter the baby’s route of administration in the route of admin data field
6. Link ICSRs as appropriate (i.e Parent/Child, Pregnancy, Twin/Triplet).

18. Enter the patient (mother) is pregnant (“Yes”).
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21. reference
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• 1. ICH Guidelines
• 2. ARISg Database

22. Thank you
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