Pharmacovigilance System

 

Lindeq establishes and maintains your pharmacovigilance system including qualified person pharmacovigilance (QPPV), preparation and maintenance of SOPs and quality management system.

Lindeq is the first service provider offering a web-based pharmacovigilance system master file (PSMF) solution including full traceability of document changes. Don't miss to have a look at this opportunity!

 

For all other pharmacovigilance tasks - for example PSUR writing, pharmacovigilance risk management plan (RMP), the management of ICSRs including adverse event reporting and narrative writing are under Operational Pharmacovigilance.

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Lindeq provides a web-based quality management system, the ItQMS™, which includes all the functionalities for maintaining a quality system including non-conformity management and training.

 

An important element within pharmacovigilance is a well working quality system. This includes having Standard Operating Procedures (SOPs) and Work Instructions (WIs) in place, including a regular update of these.

Preparing these documents can be quite a comprehensive task. We have good experience in preparing quality systems and if you already have a quality system in place, we can support you with maintenance, and prepare for possible upcoming audits or inspections.

Our services include:

  • Designing and setting up quality systems including SOPs and WIs
  • Auditing existing quality systems
  • Auditing the safety operations of your CRO
  • Assisting you in obtaining accreditations and certifications
  • Providing SOPs and system for integration with third party providers
  • Input to contracts regarding exchange of safety information
  • Providing a web-based quality management system including  non-conformity management and training

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



The EU pharmacovigilance legislation from 2012 requires a pharmacovigilance system master file (PSMF) to describe the marketing authorisation holder's pharmacovigilance system and document its compliance.

Lindeq provides a time saving, fully compliant electronic PSMF solution: we establish and maintain the PSMF in a web based system. By this the PSMF is available at all time, from any location with internet access. All documents are clearly arranged in accordance with the GVP and updated with version control and full traceability of document changes. With only one click updates compared to any previous document are visible. Restricted access ensures appropriate control over the PSMF as requested by the authorities. Additionally, the PSMF is easy available on request by the EMA or the national competent authorities.

For more detailed information please contact us directly. Together we will find the best solutions to fit your individual needs.



Since the new EU pharmacovigilance legislation is effective, MAHs have to think of implementing a PSMF. The PSMF comprises several sections describing the pharmacovigilance system that documents the compliance with the new PV requirements.

Aspects as e.g. the organisational structure of the company, information regarding the QPPV, the processing of safety data, the description of the involved computerized systems and databases, and the quality system have to be described.

Besides the preparation, the PSMF has to be continuously maintained in order to stay compliant.

Lindeq offers several solutions, such as preparing, maintaining and storing in the classic way, or with a user friendly web-based hosted solution accessible over the internet at all time.


Contact us for more details regarding our PSMF solutions.

 

 



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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Quality Management System
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PQ validations, data migrating and mapping, safety database software, EMA gateway testing
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