Improve Pharmacovigilance Compliance in In-Trial Patient Interviews
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About this webinar
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
- 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
What you will learn
- How to plan for AEs in qualitative in-trial patient interviews at the study design stage
- Establishing PV reporting processes that minimize the burden on clinical sites, maintain investigator involvement and avoid duplicate or inflated SAE reports
- Using compliant systems and automation to streamline PV processes
- Identifying best practices for clinical trial safety reporting and evaluating vendors’ ability to support PV compliance
Featured Speakers
Christine Sybert, BSc, PharmD
In her 30-year career as a US-licensed Clinical Pharmacist, Christine has practiced within multiple settings, including supervising an investigational drug service at an acute-care teaching hospital, managing a post-marketing pharmacovigilance program and serving on a healthcare system’s Institutional Review Board. As Pharmacovigilance Manager at CLINIGMA, Christine brings her varied experience from the clinical site perspective into the demands of regulatory reporting for in-trial patient interviews. She earned her Bachelor’s degree from the University of Maryland and her Doctor of Pharmacy from Temple University.
Julie Perch, MA
Julie is Chief Operating Officer at CLINIGMA, where she oversees the project management, trial management and pharmacovigilance departments. She has an excellent understanding of safety reporting of interviews in an ICH-GCP setting and has over six years of experience running in-trial interview projects for more than 16 pharmaceutical companies. She has been part of the safety discussions between the sponsor safety department and CLINIGMA, giving her a practical view of how safety reporting fits into the day-to-day running of an interview study.
Partner for this event
CLINIGMA
CLINIGMA® specializes in in-trial patient interviews, capturing the patient voice at every stage of drug development, so that what patients actually experience and value informs regulatory submissions, labelling claims, and commercial decision-making.
We conduct interviews anywhere in the world, with active operations across 35+ countries and a global network of 300+ Master’s and PhD-level researchers. All interviews are conducted in full compliance with ICH-GCP, translating authentic patient insights into regulatory-grade evidence.
We manage the entire interview process, from planning to reporting, through our own interview platform. The CLINIGMA® Portal is the first system purpose-built to securely capture patients’ own words in real time, with full compliance with ICH-GCP and global data protection standards. Alongside it, we have built CLINIGMA® Explorer. It complements the final report by allowing transcripts to be filtered, searched, and compared as they arrive, giving teams a head start on understanding what matters most to patients.