Regulators increasingly want to see the patient voice included to inform drug development and qualitative in-trial patient interviews provide valuable insights into patient experiences that can support regulatory submissions. However, these interviews may also uncover adverse events (AEs) that require timely and accurate safety reporting. Failure to meet these obligations can result in regulatory or audit findings. This webinar will explore approaches to managing adverse event reporting during patient interviews while maintaining pharmacovigilance (PV) compliance.
When qualitative in-trial patient interviews are conducted by external vendors, sponsors must ensure that appropriate processes are in place to identify, document and report safety information. This webinar will examine common challenges associated with PV reporting during in-trial interviews, including methods for collecting and reporting AEs and best practices for establishing compliant vendor processes.
The session will cover what compliant safety reporting looks like when a vendor runs qualitative in-trial patient interviews and what sponsors should expect from that vendor’s process. The featured speakers will discuss:
Common challenges in accurate and timely PV reporting for qualitative in-trial patient interviews and how to solve them
A review of the various methods for collecting and reporting AEs within qualitative in-trial interviews
An overview of best practices for a qualitative in-trial interview vendor’s PV process
Safety reporting considerations are not always addressed early in the planning of qualitative patient interviews. Applying a standardized approach to adverse events and serious adverse events (SAEs) across all trials may create operational challenges, delay interview initiation and complicate compliance. Understanding how to integrate safety reporting requirements into study design can help sponsors establish efficient reporting workflows while minimizing unnecessary burdens on clinical sites.
Register for this webinar to learn how to improve adverse event reporting during in-trial patient interviews, reduce compliance risks and streamline pharmacovigilance processes in clinical trials.
Who Should Attend
This webinar will appeal to:
Pharmacovigilance and Drug Safety teams that receive safety information from interview vendors
Clinical Operations and Study teams
Patient-Centred Outcomes, COA and Patient Experience Leads who commission qualitative research
Regulatory Affairs professionals preparing submissions that include patient experience data
Quality Assurance and GCP Compliance teams who assess vendor processes
Vendor Management and Outsourcing teams selecting an interview vendor
Register free on Xtalks: https://xtalks.com/webinars/improve-pharmacovigilance-compliance-in-in-trial-patient-interviews/
