Pharmacovigilance

All persons within the organisation should be involved in and support the pharmacovigilance system on the basis of task ownership and responsibility to a degree according to their tasks and assigned responsibilities.

Pharmacovigilance and Regulatory professionals work hand-in-hand.

The QPPV is responsible for the complete pharmacovigilance of the MAH’s medicinal products and promotes, maintains, and improves compliance with the legal requirements. To accomplish these duties, the QPPV has to be up-to-date with the status of the MAH’s products.

READY! is used extensively by the QPPV and Pharmacovigilance teams to:

  • Plan, track, and manage all pre- and post-authorisation RA and PV activities, tasks, and responsibilities
  • Promptly identify the key information about
    • Marketed finished products
    • Active substances and associated products
  • Track marketing status of each product
  • Manage RMP for each product
  • Manage the PSMF lifecycle in electronic format
  • Plan, track, and manage all pre- and post-authorisation RA and PV activities, tasks, and responsibilities
  • Ensure prompt and effective reporting and identification of tasks, responsibilities, submitted documents, and all RA, PV, and marketing statuses
  • Track Performance indicators
  • Find approved and effective product documentation (SPC, PIL, etc.)
  • Check planned variations
  • Plan and track literature searches
  • PASS

In addition to finding available information about medicinal products, they can use READY! to make their life easier by:

  • Creating automatic reports
  • Plan and track PSUR submissions
  • Track ICSR activities and submissions
  • Track key performance indicators
  • Track communication with their clients
  • Search data and export to Excel

READY! is a web-based solution that will enable you to comply with the Pharmacovigilance Regulation No. 1235/2010 and Directive 2010/84/EU.

Validation is a standard part of the implementation of READY!.

READY! provides:

  • A medicinal product database (product portfolio)
  • Full support for XEVMPD and the coming ISO IDMP submissions
  • Change management and alerting
  • An overview of all company products (in development and later including regulatory status – authorised, pending registration, change ownership, suspended, etc. – marketing status, sunset clause, launch date, MAH, country, etc.)
  • QPPV and local representative per product and country
  • PSMF location per product
  • An overview of products belonging to DDPS, PSMF, or products with no DDPS or PSMF
    Life cycle management of PSMF with annexes, SOPs, and quality manuals (versions, document status, responsibilities, etc.)
  • Life cycle management of risk management plans per product with their regulatory status, version, and dates (change date, effective date, version date, etc.)
  • PSUR cycles
  • DLPs per product
  • An overview of PSURs per product and country
  • Plan and track submissions of all PV-related activities (renewals, PSURs, safety variations, changes to RMP, etc.)
  • An overview of product information (SmPC, PIL, labelling) per product and country with defined regulatory and internal statuses
  • An overview of current labelling in the packs on the market (per product and country)
  • An overview of products with additional monitoring
  • An overview of literature search per product: global or local
  • An overview of clinical trials
  • An overview of PASS
  • An overview of all partners per product (formulation development, clinical studies, pharmacovigilance, in-licence, out-licence, co-marketing, etc.)
  • An overview of audits and inspections per product or PV system
  • An overview of all planned, active, and finished regulatory activities

A quality system has become an integral part of Pharmacovigilance. It is essential to assure the connection between both internal and external stakeholders.

Implementing READY! helps all departments communicate and easily track and find correct product information and associated documents.