The number of pharmacovigilance agreements (PVAs) are continually increasing. Inefficiencies in negotiating and complying with PVAs wastes resources and contributes to non-value adding work due to:
- Ambiguous contractual terms and definitions
- Lengthy negotiation periods
- Lack of awareness and data around operational timelines commonly used in PVAs
- Various placements of structure and content
- Lengthy contractual maintenance discussions
The Pharmacovigilance Agreements Optimization (PVAO) Initiative focuses on addressing foundational elements related to PVAs, such as the process for developing PVAs, considerations for the table of contents/glossary, and benchmarking of exchange timelines. Importantly, this initiative does not seek to produce a standard industry PVA template nor provide recommendations pertaining to data exchange. Rather, this initiative seeks to produce a customizable, interactive resource for new and experienced contract partners, which could be used to inform and/or streamline their PVA process development, contract drafting, and negotiations.
Table of Contents Draft Documents for Feedback
The Table of Contents (TOC) documents on this site are in draft form for the purpose of requesting public feedback (please use this survey link) and are not intended for use.
The Pharmacovigilance Agreements Optimization Initiative is seeking your valued feedback on the DRAFT Table of Contents (TOC) on or before Friday, October 15, 2021. Visit the survey to provide comments or, equally as important, to indicate if the content is appropriate without the need for any changes to the content. Thank you for your time and consideration!
Directions for Providing Feedback:
For this feedback, it is not necessary to comment on grammatical concerns. Review as much of this draft as you are willing or decide is appropriate based on your company requirements. Please note that it is equally important for us to understand whether the document aligns with your expectations, and therefore we ask that even if you have no comments, please open the feedback form link and select the box to indicate that you believe the content is satisfactory.
Information about the Table of Contents:
The TransCelerate Pharmacovigilance Agreement (PVA) Table of Contents is offered to:
- Support users in building a comprehensive PVA template for their organization
- Provide users with a reference guide, which could also be used as a checklist, that could support them with reviewing a partner-generated PVA
- Provide users that are new to developing PVAs or new to engaging in PVA negotiations with a comprehensive reference that contains many common considerations when developing or reviewing a PVA
The TransCelerate PVA Table of Contents offers a proposed framework of modules, headings, and points to consider, and was developed in the context of sponsor to sponsor, or marketing authorization holder (MAH) to MAH, or it could be sponsor to MAH and vice versa negotiations. The following are the modules that make up this framework:
- Module 1 – Background
- Module 2 – Pharmacovigilance
- Module 3 — Cooperation and Support
- Module 4 – Appendices and Annexes
It is recognized that other agreements exist and might benefit from some or all of the information offered in this document. The contents in this document are based on the interpretation of existing regulations, public inspection findings, and collective experience of multiple companies represented in the TransCelerate BioPharma Inc. membership. It is intended to be supplementary to the user’s existing knowledge and is not a replacement for understanding existing current Health Authority regulations; such regulations always supersede content offered in this document. 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. Please note that regulations from Japan were considered, but as Japan generally follows ICH, there are some instances where PMDA references are noted. Similarly, U.S. regulation citations were considered and noted. Furthermore, combination products with devices and vaccines were also considered; separate addendums are included that note specific points to consider for these types of products. The intent is to provide users with a comprehensive set of information that they can choose to include or exclude based on their company interpretation of regulations or company business practices.
- May reduce the time spent on drafting and negotiation of PVAs, e.g. may facilitate earlier clinical trial start
- Potentially increase awareness of applicable regulations that impact PVA development
- May improve accuracy, completeness, and timeliness of PVA and compliance with regulations
- Potentially increase understanding of general considerations for PVA development
- May serve as a resource for entities newly engaging in PVA activities, or where a dedicated PV organization doesn’t exist
- Process Map: Tool that illustrates the end-to-end PVA lifecycle and key considerations throughout the development of PVAs
- Glossary: Listing of key definitions and synonyms often incorporated into PVAs
- Table of Contents: A framework of headings and points to consider for potential incorporation into PVAs, including regulatory citations
- Benchmarks for PVA Exchange Timelines: Aggregate benchmarking data of exchange timelines in member companies’ PVAs