Participate in our Survey

Cette brève enquête est conçue pour évaluer le niveau de préparation de votre entreprise à l'audit PV à l'aide d'un simple ensemble de questions. Ces questions sont fondées sur des lacunes d'audit courantes que nous avons observées. A la fin de l'enquête, merci d'indiquer si vous souhaitez une consultation gratuite et confidentielle avec un partenaire senior de Zenith.

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ÉVALUEZ VOTRE PRÉPARATION D’AUDIT DE PV EN MOINS QUE 2 MINUTES

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Prénom(Required)

Nom de Famille(Required)

Courriel(Required)

Entreprise(Required)

How confident are you about your PV quality management system?(Required)

(Please consider your current procedures for managing deviations; external service partners qualification; challenges in identifying and implementing corrective/preventative actions (CAPAs); and oversight/compliance management of PV service provider)

How robust is your PV training and associated documentation?(Required)

Do you have clear, up-to-date PV agreement with all parties handling your PV functions and with respective PV responsibilities of each party?(Required)

In your last audit, were there are any Risk management-related findings related to poor maintenance of product safety monitoring or any request to implement additional risk minimisation measures, such as educational materials or pregnancy follow-up procedure?(Required)

Inconsistent or inadequate record keeping is a common audit finding, even when there are clear SOPs. How important is it for you to have a properly validated safety database for ICSR management?(Required)

How confident are you in meeting the exact HC guidance on benefit-risk assessment, signal detection and aggregate reports (ASRs)? Common issues include failure to include relevant cases in the benefit-risk assessment and inadequate critical analysis in ASRs resulting in delayed product information update.(Required)

Are you concerned about poor integration/interfaces between departments or with external parties to support complete and timely safety information?(Required)

Do you have appropriate systems to ensure safe archiving/backups and a supporting business continuity plan?(Required)

APPELEZ UN PARTENAIRE ZENITH DÈS AUJOURD'HUI POUR UNE DISCUSSION OU UNE DÉMONSTRATION DE NOS CAPACITÉS

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