Der Stufenplanbeaufragte / die QPPV:

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1 Der Stufenplanbeaufragte / die QPPV: The EU Qualified Person for Pharmacovigilance Forum Online, 10. November 2010 Dr. Gernot Schreiber, Head Global Pharmacovigilance & Clinical Safety and EU QPPV Sandoz International GmbH a Novartis company

2 Marketing Authorisation Holder s (MAH) Responsibilities - to have an appropriate system of pharmacovigilance (PV) in place - to resume responsibility and liability for his products on the market - to take appropriate action when necessary - to report all information relevant to the risk-benefit balance fully and promptly 2 GS: EU QPPV; Forum Online 2010

3 MAH s Responsibilities continued - to submit a Detailed Description of the PV System (current) to submit a DDPS Summary with reference to the site where the DDPS is permanently accessible for inspection (future) - to submit proof that one Qualified Person for Pharmacovigilance (QPPV) is permanently and continuosly available - to ensure full documentation regarding procedures and QPPV s activities - to have a Plan for Business Contingency in place 3 GS: EU QPPV; Forum Online 2010

4 MAH s Responsibilities continued - to provide adequate support for the QPPV with: appropriate resources available appropriate processes in place sufficient authority attributed to QPPV e.g. regarding the PV system, regulatory action, communications 4 GS: EU QPPV; Forum Online 2010

5 MAH s Responsibilities continued adequate support for the QPPV with: appropriate communication mechanisms in place information on emerging safety concerns or information with a possible impact on the risk-benefit balance, e.g. from sponsored or unsponsored studies, registries, partners access to all sources of relevant information 5 GS: EU QPPV; Forum Online 2010

6 Acceptance criteria for an EU QPPV - appropriate qualification - documented experience in all aspects of PV - medically qualified or access to a medically qualified person - residingin the EU* 6 GS: EU QPPV; Forum Online 2010

7 Responsibilities of the QPPV - to establish and maintain/manage the PV system - have overview of safety profiles & emerging safety concerns of product portfolio - act as single contact point for CAs during 24 h/d - ensure that at least one deputy (or a cascading back-up system) is in place 7 GS: EU QPPV; Forum Online 2010

8 Responsibilities of the QPPV ctd. - delegation of specific tasks is possible but needs to be documented - care for collection of safety reports and a central collation with accessibility at one point in the EU - have oversight of the PV system regarding structure (organigrams, SOPs, database, partners) and performance (training, quality, compliance) - continuous overall PV evaluation during the postauthorisation period (signal detection, verification and evaluation) 8 GS: EU QPPV; Forum Online 2010

9 Responsibilities of the QPPV ctd. - timely submission of complete and accurate ADRreports, PSURs, and reports on sponsored safety studies - answer any request from CAs fully and promptly - provide CAs with any other information relevant to the risk-benefit evaluation including all kinds of solicited reports - act as contact point for PV inspections 9 GS: EU QPPV; Forum Online 2010

10 Detailed Description of the PV System (DDPS): - Company Organigram(s) - Qualified Person responsible for Pharmacovigilance - Job Descriptions -ProductsLists - Organisation (units, subunits, activities, flow diagrams) - Procedures documented in writing (GOPs / SOPs / WIs) - Database - Links with other Organisations - Training - Documentation & Archiving - Quality Management - Risk Management 10 GS: EU QPPV; Forum Online 2010

11 Example of details regarding single items of DDPS: - Qualified Person responsible for Pharmacovigilance: name, address contact details, CV (qualification, experience, training, languages), back-up, 24-h service - Products Lists: products authorised, products marketed, products licensed-in or licensed-out, co-distribution products, co-promotion products - Procedures documented in writing (GOPs / SOPs / WIs): activities of QPPV, case processing (collection, documentation, duplicate detection, coding, quality control, classification, medical review, reporting, FU-activity), monitoring of safety profiles, PSUR preparation, response to requests from CA, use of database, staff training 11 GS: EU QPPV; Forum Online 2010

12 Comparison QPPV / Stufenplanbeauftragter EU QPPV - residing in the EEA - responsibility related to marketing authorization / application - area of responsibility: pharmacovigilance Stufenplanbeauftragte(r) - residing in the EU - responsibility related to distribution - area of responsibility: pharmacovigilance and/or pharmaceutical quality 12 GS: EU QPPV; Forum Online 2010

13 Comparison QPPV / Stufenplanbeauftragter ctd. EU QPPV - appropriately qualified - documented experience in all aspects of pharmacovigilance - medically qualified or access to respective person Stufenplanbeauftragte(r) - appropriately qualified - reliable with essential know-how/ experience 13 GS: EU QPPV; Forum Online 2010

14 Role of the German Stufenplanbeauftragter - is fully responsible for local submission of ICSRs, SUSARs, PSURs, and ARs to the BfArM - must have the necessary resources available and a local DDPS in place - coordinates the implementation of risk minimisation measures on local level - in case of centralised on-line reporting in E2B format either triggers submission to BfArM or checks reporting compliance randomly if this duty is delegated to the global department - must have either at least read access to an existing central database or alternatively be provided with necessary documents within few hours only 14 GS: EU QPPV; Forum Online 2010

15 Thank you for your attention 15 GS: EU QPPV; Forum Online 2010