QPPV 11 & 12 Dec 2011

Egyptian Drug Authority (EDA)

Egyptian Pharmacovigilance Center (EPVC)

Qualified Person for

Pharmacovigilance
(QPPV)

Ph. Hadir Mamdouh Ahmed

Team Leader of EPVC
Rapporteur of Pharmacovigilance Committee

Qualified Person for Pharmacovigilance

(QPPV)

Medicinal products cannot be marketed within Egypt

without a Qualified Person for Pharmacovigilance
(QPPV)
The MAH should have permanently and continuously at his disposal a
QPPV, residing in Egypt.
For multinational MAH; if the QPPV is not residing in Egypt then the
a Local Safety Responsible (LSR) residing in Egypt is required
Local MAH, must have QPPV

Clinical Pharmacist Hadir Mamdouh Ahmed - Team Leader of EPVC &

the Rapporteur of Pharmacovigilance Committee 1
QPPV 11 & 12 Dec 2011

Notification of details of the QPPV

In the DDPS
Even if a MAH not yet submit a DDPS, the MAH should provide
EPVC with current 24-hour contact details of their QPPV/LSR and
details of the back-up arrangements
If the MAH changes its QPPV/ LSR, the same information must be
provided for the new QPPV/LSR
EPVC will maintain a list of QPPVs (and LSRs). This list will include
business address and contact details (including out of- business
hours contact details)

Qualifications of QPPV/LSR
►Pharmacist or physician
►Ideally, the QPPV/LSR should have worked for some years in the field of
pharmacovigilance or at least have received suitable pharmacovigilance formal
training.
►Demonstrate (e.g. through qualifications, work experience and formal training)
that he/she has knowledge of applicable Egyptian pharmacovigilance legislation
and guidance, international standards for pharmacovigilance (e.g. International
Conference on Harmonization (ICH) and Council for International Organizations
of Medical Sciences (CIOMS) guidance.
►Demonstrate (e.g. through qualifications, work experience and formal training)
that he/she has knowledge of the key pharmacovigilance activities performed as
part of the MAH’s pharmacovigilance system & how to implement them.
►The MAH should ensure that the QPPV/LSR has access to a medically qualified
person if the QPPV/LSR is not medically qualified (pharmacist).

Clinical Pharmacist Hadir Mamdouh Ahmed - Team Leader of EPVC &

the Rapporteur of Pharmacovigilance Committee 2
QPPV 11 & 12 Dec 2011

Responsibilities of QPPV/LSR

3 key functions:
►Establish and maintain the Market Authorization Holder’s (MAH)
Pharmacovigilance System (including all activities which contribute to the
detection, assessment, understanding and communication of safety
information, as well as risk management activities). In addition, the LSR is
responsible with the QPPV for maintaining the MAH Pharmacovigilance
System in Egypt.
►Oversee the safety profiles of the company’s marketed products and any
emerging safety concerns.
►Act as a single point of contact for the regulatory Authorities on a 24-hour
basis, and provide the contact point for Pharmacovigilance inspections.

Responsibilities of the MAH in Relation to

the QPPV/LSR
The MAH should:
►provide comprehensive training in Pharmacovigilance to the QPPV
►Ensure that the QPPV/LSR has sufficient authority to:
 implement PV activities,
 provide input into RMP,
 provide inputs into the preparation of regulatory action in to emerging safety
concerns (e.g. variations, urgent safety restrictions, and, as appropriate,
communication to Patients and Healthcare Professionals)
►Ensure that there are appropriate processes, resources,
communication mechanisms and access to all sources of relevant
information in place for the fulfillment of the QPPV’s/LSR’s
responsibilities and tasks.

Clinical Pharmacist Hadir Mamdouh Ahmed - Team Leader of EPVC &

the Rapporteur of Pharmacovigilance Committee 3
QPPV 11 & 12 Dec 2011

Special consideration for Multinational

MAH/Applicant

►QPPV residing in Egypt (if not, regional QPPV or global QPPV)…… in

addition to that QPPV a LSR residing in Egypt.
►All the conditions and qualifications applied for QQPV apply also for
LSR.
►LSR will represent a single point of contact with EPVC.
►Similar tothe QPPV, the LSR should be physician or pharmacist
experienced/trained in Pharmacovigilance.
►The ultimate goal is to ensure that Egypt LSR is adequately qualified in
Pharmacovigilance and has wide background about Pharmacovigilance
activities even those not regularly performed by him, but he may get
involved in them in special situations to fulfill EPVC requirement

Take Home Messages

 Adequately experienced and trained QPPV is the 1st step of a good PV
system
 QPPV/LSR residing in Egypt
 QPPV should have adequate authority, access to the needed
information
 LSR role should NOT be restricted to just forwarding data to the
global QPPV
 QPPV/LSR training should be extended beyond “training on MAH
SOPs”
 QPPV/LSR disseminate EPVC regulations to your MAH headquarter,
so they can adequately provide support to establish/ develop Egypt
office PV system, fulfill all requirement
 Local MAH should start immediately
8

Clinical Pharmacist Hadir Mamdouh Ahmed - Team Leader of EPVC &

the Rapporteur of Pharmacovigilance Committee 4