QPPV package

Lindeq provides a complete QPPV package covering all aspects that are required within the new EU pharmacovigilance legislation.

 

A Marketing Authorisation Holder (MAH) is responsible for having a Qualified Person for Pharmacovigilance (QPPV) on place. The QPPV is responsible for the complete pharmacovigilance of the MAHs medicinal products and promotes, maintains and improves compliance with the legal requirements.

 

To accomplish these duties, the QPPV has to fulfil several criteria: besides being always up to date with the pharmacovigilance status of the MAH's products, the QPPV must have a profound knowledge of all pharmacovigilance tasks including all current legal requirements. The QPPV has to live within the EU/EEA, being accessible on a 24/7 basis and has to have a backup (deputy QPPV). The pharmacovigilance system master file (PSMF) must also be accessible to the QPPV at any time.

 

Lindeq provides the following package:

  • QPPV who is experienced in pharmacovigilance (typically Master's degree and minimum 2 years full time practical experience in pharmacovigilance)

  • If the QPPV is not medically qualified, 24/7 access to a physician with appropriate qualifications.

  • Named deputy QPPV to serve as back up for the QPPV

  • Logistics of the back-up system

  • Hosting of a web based electronic PSMF, accessible both to the MAH and the QPPV

  • Pharmacovigilance training of all respective employees within your company

  • 24/7 contact details of QPPV and deputy QPPV

  • An organization experienced in pharmacovigilance that will provide resources as necessary

 

For more detailed information please contact us directly.




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Operational pharmacovigilance
ICSR management, EudraVigilance, RMP, CCSI, PSUR, DSUR, Signal management, XEVMPD, and many more.
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Pharmacovigilance System
QPPV/deputy QPPV, SOPs, Quality Management Systems, (electronic) PSMF
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Management of SUSARs and SARs, safety narrative writing, medical assessments and DSUR
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Medical Device Vigilance
Full range of medical device safety services for all different types of medical equipment
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Quality Management System
Web-based quality management system software including training and document management
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Audits & other support
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Pharmacovigilance related IT
PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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