Who is the EU QPPV and what do they do?

Fiorenza GaudenziQ2-2015

The role of the EU QPPV

0WHO is the EU QPPV?0WHEN is a EU QPPV needed?0WHERE do they operate?0WHAT are their responsibilities?0WHY - legislative references0HOW – useful tips

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

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

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 responsable0 Germany: Stufenplanbeauftragter0 Italy: Responsabile di Farmacovigilanza

0 Could be the same person as the QPPV0 de facto especially in small companies it is the Local Medical Dir

(or Reg Affairs Dir)

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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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

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 EEA0 Immediately informs the CA of newly identified safety concerns within

ongoing clinical studies0 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

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WHAT: the challenges

0Lack of understanding of QPPV role0EU legislation in name only, but Global impact 0Cross functional: leaves virtually no function

untouched0Significant changes in multiple processes required0New skill sets required 0Extensive education and training for non-PV functions0Lack of harmonization with non-EEA countries

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/EC0 Volume 9 of The Rules governing Medicinal Products in the

European Community (1998)

HOW: some practical tips

0Build a network (centrally and with local QPs: regular TCs, meetings, formalized information flow)

0e-room/ Share Point 0Repositories0F2F 0Newsletters 0Create centres of expertise0Develop ownership of fellow QPPVs

HOW: the MAH and the QPPV

0 MAH and QPPV have overlapping and interdependent obligations as regards pharmacovigilance.

0 Who is liable for compliance? BOTH0 The MAH “must adequately support the QPPV”:

0 Resources0 Processes0 Communication mechanisms0 Access to sources of information0 Procedures and activities documented

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QPPV – in a nutshell

If something has any connection with thesafety of a product marketed in EU, the QPPV is:0Responsible for making it happen

0 Globally0 Properly

0Personally legally liable if the above isnot the case

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