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Qualified Person For Pharmacovigilance (QPPV) : Ph. Hadir Mamdouh Ahmed
Qualified Person For Pharmacovigilance (QPPV) : Ph. Hadir Mamdouh Ahmed
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).
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.