08/Aug/2007

Doc. 116588 Ed.1.0

Handling Customer Complaints
and Adverse Events and other
safety information
MRA
25-Oct-2007
QUALITY

• Definition NNWoM
Quality is:
• Meeting or exceeding customer expectations
• Getting it right the first time
• Being innovative and creative
• Defining and improving work processes
 Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0
• Novo Nordisk wants to know ALL COMPLAINTS
• Why ?
• because we want to improve our products
• New and modified products comes from requirements specified
by the customer are captured during Clinical trials, marketing
surveys and from customer complaints
• because we want to ensure patient & product safety
• because we want to have a satisfied customer
• Customer surveys are performed and the results are
communicated throughout the organisation
• Timely reporting of Serious Adverse Events and Adverse Events
• Why ?
• It is our obligation to the patient
• It is our obligation to regulatory bodies (FDA-EMEA)
• Our reputation depends on it
 Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0
• DEFINITIONS:

• Customer: is defined as the end user of Novo Nordisk products and

services.

• Customer Complaints (CC): any written, electronic or oral

communication that alleges deficiencies related to the identity, quality,
durability reliability, safety or performance of any NN products placed on
a market or used in clinical trials studies. CC includes Adverse Events,
products defects or combinations

• Adverse Events (AE): Any untoward medical occurrence in a patient or

clinical investigation subject administered a pharmaceutical product and
which does not necessarily have to have a causal relationship with this
treatment. An adverse event can therefore be any unfavourable and
unintended sign (including an abnormal laboratory finding, for example),
symptom, or disease temporally associated with the use of a medicinal
product, whether or not considered related to the medicinal product.
Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0
• Serious Adverse Events (SAE): A serious adverse event is an
experience that at any dose results in any of the following outcomes:
• Death,
• a life-threatening experience [1],
• inpatient hospitalisation or prolongation of existing hospitalisation,
• a persistent or significant disability/incapacity or is a congenital
anomaly/birth defect.
• Important medical events that may not result in death, be life-
threatening, or require hospitalisation may be considered a serious
adverse event when based upon appropriate medical judgment, they
may jeopardize the patient or subject and may require medical or
surgical intervention to prevent one of the outcomes listed in this
definition.

[1] The term life-threatening in the definition of serious refers to

an event in which the patient was at risk of death at the time of
the event. It does not refer to an event, which hypothetically
might have caused death if it was more severe.
 Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0
• Safety Information

• All reports of adverse events occurring during the use of a Novo Nordisk
product.
• In addition, any other information relevant to the safety of the product:
• All reports relating to pregnancies, including outcome of a
pregnancy, where the foetus may have been exposed to a Novo
Nordisk product through parental exposure
• Any adverse event occurring in infants following exposure to a Novo
Nordisk pharmaceutical product from breastfeeding
• Reports of lack of efficacy
• Any suspected transmission of an infectious agent via a Novo
Nordisk product
• All reports of overdose, drug abuse, drug misuse occurring with a
Novo Nordisk product
• All reports of medication errors involving exposure to a Novo Nordisk
product
 Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0
• Responsibilities:
• General Managers:
• Appoint a person with local responsibility for pharmacovigilance and
ensure compliance with any local legislation concerning handling of
safety information
• Maintenance of a Safety Information Agreement with IPS to ensure
exchange of safety information.
• Managers in any position:
• Managers involved in making agreements with contractual partners
must ensure that written safety agreements are in place The exchange
of safety information must be specified and compliant with the
requirements of the present document. (ROFE Doc 040334)
• Distributors:
• Responsible for channelling to Novo Nordisk LQRP all information
relating to customer complaints, and AEs, including any information
about pregnancy during use of Novo Nordisk products or devices within
24 hours from receiving the information.
Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0

• All employees:
• must immediately (same day) report to LQRP
(FEFI/MIML) any safety information in any format,
electronic by email, oral communication, letter, phone call
etc, on a customer complaint or adverse event reported
spontaneously or originating from a regulatory authority,
literature or clinical study not sponsored by NN.
• LQRP:
• Ensure that timelines for reporting of CC, AEs, SAEs and
pregnancy from the SOP are kept, prepare and follow up
reports to IPS. Report trends of complaints to Line
management during MMR and QMR.
Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0

• What information I must send to LQRP?

• Product (product name as detailed as possible): Indication, start date, stop date
and dose.
• Customer Complaint/Adverse event: Description (as detailed as possible)
including start date, stop date and outcome. If reported by a Health Care
Professional (HCP): causality assessment
• Patient: Age, gender, initials.
• Reporter Name: HCP or consumer initials (it is sufficient that the reporter is
identifiable at affiliate level).
• Name: Patient/doctor name Country: Indonesia
• Institution: Hospital/Clinic etc, if any
• Telephone: Patient/doctor/other contact phone
• Address: Patient/Hosp/Clinic address Fax: patient/clinic/hosp etc
• City: Jakarta Profession: Patient or Doctor
Handling CC- AE and SAE and Other Safety
Information Doc. 116588 Ed. 1.0

• Samples, if any, must be kept untouched,

identified and send to LQRP in appropriate
packaging. (According Product Specification Doc.
040747 current ed.)

• It is not our responsibility to decide if the

event is or not related to the product. This
is the physician responsibility.
Contact Number for informing Adverse Events
and SAE outside normal working hours

• In case of ANY information on AE received during

WEEKENDS or OUTSIDE NORMAL WORKING HOURS
please contact one of these numbers same day.

• FEFI – Felicia Fikri + 62 8121 009438

• MIML – Maria Melisa + 62 8129 693955
• ISOE – Dr. Uti + 62 8129 185153
• MRA – Marcia R. Alexandre +91 9901 97 35 81
HAPPY CUSTOMER

• HAPPY CUSTOMERS smooth sailing for the company.