PVA Process Map

Product development and marketing can be executed in diverse collaborations or support structures. While the types of business relationships can vary significantly, the overall responsibility for the pharmacovigilance system always remains with the Marketing Authorization Holder (MAH) / sponsor. Business relationships that affect the PV system are documented in PV contractual arrangements, often referred to as pharmacovigilance agreements (PVAs) or safety data exchange agreements (SDEAs), as required by regulations. Such agreements become an essential component of the PV system and allow MAH/ sponsor to fulfill obligations towards Health Authorities and PV partners.

PVAs follow a lifecycle that begins with establishing a new partner collaboration and ends with termination of the PVA. Management of PVAs requires time, resources and expertise. Failure to have a PVA in place in a timely manner may result in delays to clinical trial start, launch, and/or asset transfer, and may result in inspection/audit findings.

*A THICK LINE AROUND EACH BOX INDICATES THAT THERE ARE TOOLS ASSOCIATED WITH THIS STEP OF THE PROCESS. ADDITIONAL TOOLS FOR OTHER STEPS ARE UNDER DEVELOPMENT.

TOOLBOX: Pre-PVA Involvement of Pharmacovigilance (PV) Function

PROBLEM STATEMENT:

  • Functions managing business collaborations are the key internal stakeholders to involve PV in a timely manner when it comes to a new business relationship or main agreement amendment.
  • Although companies often have processes that address these cross-functional responsibilities, the lack of awareness or understanding about when to involve the PV function is likely attributed to inefficient or ineffective communication.

SOLUTION:

  • This slide deck offers points to consider through tangible elements of communication and stakeholder management that can help improve the timely involvement of PV.
  • Optional example text for effectively communicating with stakeholders about timely involvement of the PV function is provided in a slide deck and can be customized based on the individual needs and processes in any organization.

TOOLBOX: Systematic Approach to PVA Negotiations
A customizable agenda and slide deck for PVA negotiation kick-off meetings

PROBLEM STATEMENT

  • PVA negotiations can have long durations, often resulting from repeated steps due to the lack of structure and common understanding.  This may include, but is not limited to, the following:
    • Lack of relevant stakeholder involvement
    • Lack of understanding for partner requirements and practices
    • Different understanding of business set-up between the partners

SOLUTION

  • This solution offers ideas for improved PVA negotiation efficiency through applying elements of project management.
  • Systematic approach to PVA negotiations is based on a simple structure, proactive communication, and common understanding between partners, including:
    • Clear kick-off agenda and timeline agreement
    • Stakeholder role/responsibility identification
    • Common understanding of PVA scope and business set-up

TOOLBOX: Systematic Approach to PVA Negotiations Excel Gantt Tool

PROBLEM STATEMENT

  • Negotiations can have long durations, often resulting from repeated steps due to the lack of structure and common understanding. This may also include a lack of planning and commitment to the PVA finalization timelines.

SOLUTION

  • This solution is an Excel-based Gantt tool that can improve PVA negotiation efficiency through applying elements of project management by:
  • Agreeing on the PVA finalization timelines
  • Reaching common understanding between partners on the deliverables

TOOLBOX: Digital Signatures for PV Agreements Tool

PROBLEM STATEMENT

  • Some companies continue to decline to accept digital signatures even if allowed by local legislation
  • Overcoming barrier for not accepting digital signatures may allow for greater efficiency in the PVA process

SOLUTION

  • This slide deck offers:
    • A summary of the potential advantages of using digital signatures
    • A summary of the potential challenges companies might encounter with digital signatures and how to potentially overcome them
    • Slides could be used to support partner discussions on adoption of digital signatures in territories where it is allowed by local legislation

TOOLBOX: Periodic PVA Review: Checklist & Documentation

PROBLEM STATEMENT:

  • PVAs require periodic review as part of maintenance.
  • Documentation of PVA periodic review may be requested during audits and/or inspections.

SOLUTION:

  • This checklist is designed to provide suggestions for consideration for conducting periodic PVA reviews.
  • This checklist may be modified to align with your company process.
  • This document may also be used to document that the review was completed.