The Pharmacovigilance Agreements Optimization (PVAO) Initiative is focused on developing solutions and accompanying tools to address challenges across the lifecycle of pharmacovigilance agreements (PVAs). With the increasing volume and complexity of PVAs, the need for simplification and efficiency is greater than ever. Our suite of solutions is designed to be adaptable and flexible to support diverse PVA stakeholder needs and improve efficiencies.
All tools are currently available for use and download from our site. You can view and download the publication “Negotiating your way through the vigilance agreement maze – is there a better way?” which addresses the landscape of Pharmacovigilance Agreements and outlines the integrated set of solutions developed to address the challenges. A webinar recording is available, which demonstrates how these solutions can help organizations improve their processes and achieve more efficient negotiations with their business partners.
Process Map
The Process Map solution illustrates the end-to-end PVA lifecycle and offers key considerations throughout the development and maintenance of PVAs. In addition, there are several sets of tools available to address key bottleneck areas within the lifecycle, e.g., negotiation. Overall, the Process Map facilitates understanding of the PVA development and maintenance process and provides practical guidance for direct or indirect cross-functional stakeholders.
Process Map
Check out the Interactive Process Map, complete with key considerations and tools.
Download and view this video, which explains how the Process Map can be used and provides some background on how it was created.
Download now — Process Map (PDF Version)
PROCESS MAP TOOLS
Pre-PVA Involvement of Pharmacovigilance (PV) Function
This tool is a customizable presentation for functions responsible for creating PVAs who engage with internal stakeholders managing business collaborations and is designed to help them understand the need for PV involvement. The presentation focuses on the benefits of involving PV early in the process and supports fostering efficient relationships between functions. Click here to download the tool or access it within the Interactive Process Map.
Systematic Approach to PVA Negotiations
Below are a set of tools that offer an optional framework for PVA managers to help enhance the efficiency of PVA negotiations through a project management approach. See the specific tools below.
- Five Steps for Efficient Negotiation—This graphic illustrates a concept of how to gain efficiency in PVA negotiation in five steps.
- Kick-off Agenda—A presentation slide deck that can be used to plan and facilitate a kick-off meeting with negotiation stakeholders before drafting a PVA.
- Gantt Chart—Provides a project plan template to help manage PVA negotiation timelines between the PVA partners.
These tools can also be accessed within the Interactive Process Map.
Digital Signatures for PV Agreements Tool
This tool 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
Click here to download the tool or access it within the Interactive Process Map.
Periodic PVA Review: Checklist & Documentation
This document can be used to help determine whether a PVA may need to be updated during a periodic review. It also provides space for documenting the periodic review and any required subsequent actions. Click here to download the tool or access it within the Interactive Process Map.
Glossary
To assist with the PVA process, the Glossary contains a listing of key definitions and synonyms often incorporated into PVAs. The Glossary also includes an “Addendum” that provides additional contextual information for the key definitions, including regional definitions, e.g., EU, USA. This solution can help stakeholders operate more efficiently through all phases across the PVA lifecycle by supporting a common understanding of key terminology and definitions.
The Glossary was updated in July 2022 to Version 2.0 to provide additional definitions, hyperlinks, cross-referenced related items, and an optimized alphabetical table.
Download now—Glossary. The Glossary can also be accessed here within the Interactive Process Map.
Download and view this video, which explains how the Glossary can be used and provides some background on how it was created.
Table of Contents
The TransCelerate PVA TOC offers a framework of modules, headings, points to consider, and regulatory references in relation to pharmacovigilance exchange of information and obligations between parties. This TOC was developed in the context of sponsor to sponsor, marketing authorization holder (MAH) to MAH, or sponsor to MAH and vice versa negotiations.
Similar to other documents, such as the Periodic Benefit Risk Evaluation Report (PBRER), where a regulation-based structure and content exists, we consider that this framework could offer efficiencies when managing PVAs throughout their lifecycle.
Download the PVA Table of Contents now.
The framework is comprised of four modules:
- Module 1 – Background: Includes several sections which can be included in the Main Agreement and the PVA, or just in the Main Agreement. This module addresses the terms of agreement, legal sections, and administrative information. Therefore, this module may also relate specifically to the individual company guidelines and legal requirements.
- Module 2 – Pharmacovigilance Activities: Addresses the pharmacovigilance operational activities required for companies by legislation. It is not intended to be an exhaustive list, as the activities may depend on and be specific to the particular agreement and/or product.
- Module 3 – Cooperation and Support: Addresses the quality management system, compliance, record management, governance, business continuity, audits and inspections.
- Module 4 – Appendices and Annexes: Addresses potential topics for appendices, (if not addressed in one or more of the other modules).
Download and view this video, which explains how the Table of Contents can be used and provides some background on how it was created.
Click here to download the Table of Contents Supplemental Materials. The supplemental materials provide additional considerations and examples as a supplement to some modules in the Table of Contents. Furthermore, it provides additional points to consider for Database Transfer Agreements.
Timelines Benchmarking
The article “Pharmacovigilance Agreements: Negotiating Safety Data Exchange Timelines: To Agree to Disagree? That is the Question”, was potentially the first benchmarking survey of contracts covering safety data exchange conducted within the pharmaceutical industry (the survey was issued to TransCelerate member companies). Data were analyzed to determine the most common types of safety data exchanged, and the associated data exchange timelines. These data may provide an opportunity for companies to assess how their own timelines compare with others, and to consider whether there are actions they may take that could potentially improve negotiation and procedural efficiency. Ninety percent of the recipients responded to the survey, providing information from 378 individual contracts which included data from clinical trials and from post marketing sources.
Audit Process Efficiency
AUDIT PROCESS EFFICIENCY
With the increasing number of audits and focus on improving regulatory compliance there is a clear need to optimize the marketing partner audit process. The following suite of solutions provides marketing partner audit considerations that have the potential to drive efficiency within organizations and help reduce audit burden.
AUDIT PROCESS EFFICIENCY TOOLS
Marketing Partner Audit Risk Prioritization
This document outlines considerations for a risk-based approach to prioritizing and scheduling Marketing Partner audits.
A risk-based approach to marketing partner audits helps the MAH focus audit resources on those partners with highest risk to the organization’s pharmacovigilance system.
Click here to download the solution.
Furthermore, there is an example Marketing Partner Audit Risk Assessment Scorecard provided. A risk-based approach qualifies the areas of risk for the partners in the audit ‘Universe’ (inventory). A scorecard like the example one provided can help companies develop a risk-based score derived from company-selected and analyzed criteria. This can be used to differentiate between partners and to help identify audit candidates.*
Click here to download the example scorecard.
Marketing Partner Audit Scheduling & Scoping
This solution provides some points to consider when scheduling and scoping business partner audits. Note that this solution deals with the preparation phase of the audit lifecycle and helps design the appropriate scope for pharmacovigilance audits.
Click here to download the solution.
Marketing Partner Audit Conduct
This solution offers options and considerations on different audit approaches which can help generate efficiency in the marketing partner audit program. These tools provide alternative options to the traditional audit approach where each partner audits each other independently on a routine cycle. Not all tools are suitable for every partnership and deployment will depend on set-up and design.
Click here to download the solution.
Marketing Partner Audit Responses and Follow-Up
This solution provides some points to consider before starting audit response development. The tools deal with the end of the audit lifecycle, specifically the audit response process and CAPA follow up.
Click here to download the solution.
*Please note that this is an example scorecard only and identifies only a subset of possible risk factors for audit prioritization. Each individual organization will need to assess its own particular risk factors and determine its own preferred algorithm for scoring risk based on its individual marketing partner audit portfolio. Please also be sure to review the Legal Disclaimer provided on the example scorecard.