A brief summary of the EU QPPV role

2. The role of the EU QPPV
0 WHO is the EU QPPV?
0 WHEN is a EU QPPV needed?
0 WHERE do they operate?
0 WHAT are their responsibilities?
0 WHY - legislative references
0 HOW – useful tips

3. WHO is the EU QPPV?
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• The QPPV “is a natural person”
• “appropriately qualified”
• If not a physician, “… access to a medically
qualified person should be available” (24/7)
• “Documented experience”
• Name and 24/7 contact details notified to CAs and
Agency/EMA plus back-up (Deputy or 24/7
delegates)
• Can delegate activities to appropriately trained
personnel (documenting such delegation and
ensuring training for PV personnel is up-to-date and
documented), but still remains personally liable

4. WHEN is a QPPV needed?
0 Anyone marketing a medicinal product in any of the 27
Member States of the European Union (EU) or the 3 EEA
Member States (Iceland, Liechtenstein and Norway) must
have a QPPV.
0 Also anyone applying to market a product in the above
countries must prove they have the services of a QPPV in
their MAA
0 Can be a different QPPV for separate PV systems (e.g. one
each for OTC, pharmaceuticals and vaccine divisions)
0 Applies to all MAA procedures (centralised, decentralised,
MR, national).
0 Clinical trial Sponsors only don’t need a QPPV

5. WHERE?
EU QPPV vs the national QPPVs
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0 The EU QPPV must reside and work in EEA (including Norway,
Iceland and Lichtenstein)
0 Requirement for a national QPPV, e.g.,
0 France: Pharmacien responsable
0 Germany: Stufenplanbeauftragter
0 Italy: Responsabile di Farmacovigilanza
0 Could be the same person as the QPPV
0 de facto especially in small companies it is the Local Medical Dir
(or Reg Affairs Dir)

6. WHAT: the QPPV Responsibilities 1
0 Acts as a single point of contact concerning safety of marketed [n.b. any
time past submission] products and PV inspections and ensures that a
system is in place to be continuously available to be contacted by RA in
Europe
0 Is responsible for the establishment and maintenance of a PVS within the
Company, meaning they have oversight over the functioning of the system in
all relevant aspects, including its quality system, and must have sufficient
authority over the PVS as to promote, maintain and improve compliance
with the European legislation
0 Has access to the PSMF from one point in the EU, is notified of any changes
to it and has authority over it, as to ensure information contained in the
PSMF is an accurate and up-to-date reflection of the PVS under their
responsibility
0 Has an overview of medicinal product safety profiles and any emerging
safety concerns
0 Ensures a full and prompt response to requests from CAs for the provision
of additional information necessary for the BR evaluation of a medicinal
product
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7. 0 Is informed of all PV inspections and audits; they should be able to trigger an audit where
appropriate. Is also informed of audit and inspection findings and ensures CAPA are
implemented.
0 Ensures that safety data are available from the GSD at any time, and has overview on the
validation status of such database
0 Is aware of:
0 any conditions or obligations adopted as part of the MAs and other commitments relating to safety or
the safe use of the products;
0 risk minimisation measures (and is responsible for the quality, accuracy and scientific integrity of
those and the plan describing them);
0 RMP (and has sufficient authority over the content);
0 PASS requested by a CA including the results of such studies; any CA opinion/assessment/decision
(e.g. PSUR assessment report conclusions) in order to ensure that appropriate action takes place
0 Is involved in the review and sign-off of protocols of PASS conducted or included in a RMP
agreed in the EEA
0 Ensures conduct of PV and submission of all PV-related documents in accordance with the
legal requirements and GVP
0 Ensures the necessary quality, including the correctness and completeness, of PV data
submitted to the CAs
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WHAT: the QPPV Responsibilities 2

8. 0 Provides input into the preparation of regulatory action in
response to emerging safety concerns (e.g. variations, urgent
safety restrictions, communication to patients and Health Care
Professionals)
0 Determines the signatory responsibilities for the PSUR submitted
in the EEA
0 Immediately informs the CA of newly identified safety concerns
within ongoing clinical studies
0 Ensures quality, including accuracy, timeliness, and completeness of
data submitted to the CAs within the PSURs and full response to
requests related to the PSUR by the CAs
0 Is involved in the due diligence process in case of acquisition of
other products or companies and ensures appropriate contracts are
effective and kept updated with any marketing partners for named
products to ensure collection, distribution, and reporting of safety
data received by marketing partners for such products
0 Ensures that the Company has adequate disaster recovery plans to
allow continuance of PV activities
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WHAT: the QPPV Responsibilities 3

9. 9
WHAT: the challenges
0 Lack of understanding of QPPV role
0 EU legislation in name only, but Global impact
0 Cross functional: leaves virtually no function
untouched
0 Significant changes in multiple processes required
0 New skill sets required
0 Extensive education and training for non-PV functions
0 Lack of harmonization with non-EEA countries

10. WHY: the legislative references
0 GVP Modules (Mod. I and II in particular)
0 EU Directive 2010/84/EC (superseding Dir 2001/83/EC)
0 Volume 9A of The Rules governing Medicinal Products in
the European Community (Sep-2008)
0 EU Directive 2001/83/EC
0 Volume 9 of The Rules governing Medicinal Products in the
European Community (1998)

11. HOW: some practical tips
0 Build a network (centrally and with local QPs: regular
TCs, meetings, formalized information flow)
0 e-room/ Share Point
0 Repositories
0 F2F
0 Newsletters
0 Create centres of expertise
0 Develop ownership of fellow QPPVs

12. HOW: the MAH and the QPPV
0 MAH and QPPV have overlapping and interdependent
obligations as regards pharmacovigilance.
0 Who is liable for compliance? BOTH
0 The MAH “must adequately support the QPPV”:
0 Resources
0 Processes
0 Communication mechanisms
0 Access to sources of information
0 Procedures and activities documented
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13. QPPV – in a nutshell
If something has any connection with the
safety of a product marketed in EU, the QPPV is:
0 Responsible for making it happen
0 Globally
0 Properly
0 Personally legally liable if the above is
not the case
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