Negotiating Your Way Through the Vigilance Agreement Maze-is There a Better Way?
Ther Innov Regul Sci
; 57(5): 1017-1029, 2023 09.
Article
de En
| MEDLINE
| ID: mdl-37270450
ABSTRACT
The pharmacovigilance agreements (PVA) landscape has evolved over recent decades with rapid growth in the number and complexity of partnerships, mergers, and acquisitions between pharmaceutical companies. Simultaneously there has been increasing scrutiny from regulatory authorities. Detailed regulations and guidance are lacking in this domain; hence companies have developed their own processes, templates, and tools, which have headed in different directions. Where feasible, marketing authorization holders (MAHs) have written contracts based on mutually understood requirements. Currently, MAHs are striving to find optimal solutions that safeguard patients, and in turn, support pharmacovigilance compliance. Through the TransCelerate BioPharma consortium MAHs are seeking simplification and efficiencies, to optimize the process of developing contractual agreements for pharmacovigilance. A survey of MAHs confirmed the perceptions above, and the need for efficient solutions to help navigate through the maze of complexity. The authors have led the development of tools and techniques to enable partnership between MAHs, and ultimately to support patient safety.
Mots clés
Texte intégral:
1
Collection:
01-internacional
Base de données:
MEDLINE
Sujet principal:
Négociation
/
Pharmacovigilance
Limites:
Humans
Langue:
En
Journal:
Ther Innov Regul Sci
Année:
2023
Type de document:
Article
Pays d'affiliation:
États-Unis d'Amérique