POINTERS

MINIMUM CRITERIA
1. identifiable reporter
2. identifiable patient
3. Adverse Drug Rxn
4. Suspect drug
ANYONE CAN REPORT AE:
1. hcp
2. non hcp
3. patient
4. investigator
Pharmacovigilance is a science contributing to the
protection of patients and public health.
We need an efficient Pharmacovigilance system to...
Fulfill our manufacturer's responsibility towards patients
and health care professionals.
Fulfill all regulatory reporting requirements worldwide.
Anticipate or minimize risks and to take appropriate
measures accordingly.

AE Information
Reports where the embryo or foetus may have been
exposed to the
medicinal product with and without AEs (Drug
Exposure During
Pregnancy (DEDP)).
Drug abuse / misuse
Overdose with and without event
Medication Error with and without event
Off-label use with and without event
Therapeutic response increased and/or Unexpected
Benefit
Lack of efficacy
Occupational Exposure
Interactions with adverse events

OPU LEVEL SPONTANEOUS REPORTS

Receipt of the Information
Verify if minimal criteria are fulfilled
Duplicate check based on the Local tracking Sheet
Create a local case ID number
Determine Company receipt date
Send Queries if needed, using the Product Quick Guide
(PQG)
Enter all data in AER (Adverse Event Reporting) form in
English language
Perform quality check on the AER form incl.
documentation
Forward the AER form to GCM for processing in ARISg
Archive the source documents

Listedness
Definition of Listedness:
An adverse event is listed if it is adequately described
with regard to nature, severity and frequency in the
Company Core Data Sheet (CCDS) or Investigational
Brochure

In Clinical trials the reference documents for listedness

are defined in the clinical trial protocol (e.g. for a
comparator drug or placebo).

Expectedness
An Adverse Event is expected, if it is adequately
described with regard to nature, frequency and severity
in the country specific local Patient Information Leaflet
(PIL) or Summary of Product Characteristics (SPC).

The Product Quick Guide is an electronic document

updated on a regular basis which:
Is to be used to ask queries as early as possible in the
workflow
Has to be used during case processing by all involved
colleagues, i.e.

locally by OPUs, by Global Case Management: TRIAGE &

SCIENTIFIC REVIEW and by
MEDICAL REVIEW
Contains general questions, questions on medical
concepts and product specific questions as well as
useful links (i.e. to product specific questionnaires)
Most current version of PQG will be available via a
Share Room - Case processing support
Pregnancy - TRUE
DEDP must be reported and follow-up always needed
Mother pregnant 5 years ago and did not experience AE
but she took BI Drug *PROCESS*
SPONTANEOUS - Follow-up
if the information is not sufficient:
standard report form
2nd attempt: minimal
REFUSED?
document AER form / ARISg
NON HCP
still necessary to obtain info from HCP
SOURCE CLASSIFICATION
UNSOLICITED SOURCES:
Spontaneous reports from:
Healthcare professionals, patients, consumers
Literature reports
Health Authority Reports
SOLICITED SOURCES:
Clinical trials (CT)
Compassionate Use Programs (CUP) that actively
collects Aes
Named patient use programs (NPU)
Non-investigational Studies (NIS)
Registries
Non-trial activities (NTAs)

FAX Saturday 9 November 2013

LRD : November 9, 2013
Company Receipt Date
Regulatory Time Clock - LRD
Any employees who reported Scientific Articles must
submit to Global Case Management for further
processing
INITIAL RECEIPT DATE
CRO when working employee become aware of
adverse event
screen LOCALLY
AESI
process in serious
post marketed products
PRODUCT QUICK GUIDE
query process and address in the workflow