The updated ICH E2D guideline on post-aproval safety data management, higlights that organised data collection systems – key solicited sources of post-approval safety information, have expanded and are more frequently used. As a result, the updated guidance provides more practical direction for managing of post-approval drug safety information, including safety considerations for Patient Support Programmes (PSP).
PSP include a mechanism for two-way communcation between the Marketing Authorisation holder (MAH) (or a third party acting on the MAH’s behalf) to support safe and effective use of the medicinal product. Innovative biological medicines often require more complex delivery devices than traditional tablets, terefore PSPs provide significant benefit by educating patients, suppoting additional risk-minimisation measures (aRMM), reducing administration errors. They also contribute to better overall outcomes while also generating valuable real-world insights on product use.
However, behind the “support”, Pharmacovigilance faces substantial challenges. PSPs creates complex obligations related to solicited information collection, data handling, vendor protection, and maintening PV compliance across all programme elements. This webinar will explore practical ways how these challenges can be effectively managed and overcome and will outline practical approaches to building PV frameworks for programmes involving organised solicited data collection.
Join us on 26 March at 12:00EET
Presenter: Ieva Kupciunaite is a skilled Pharmacovigilance Expert with 8+ years of experience in the pharmaceutical industry, currently specializing in QPPV office pharmacovigilance activities, acting as QPPV/deputy QPPV and coordinating clinical safety and global PV projects.
Ieva has extensive hands-on experience in planning and leading PSP projects from the PV perspective, covering solicited data collection, compliant PV system setup for homecare programmes, and cross-functional collaboration to ensure high-quality and compliant handling of solicited information on behalf of Marketing Authorization holders. Ieva’s current QPPV Office expertise and homecare programme experience make her a strong asset in driving PV compliance and quality in solicited information activities.
Participants will gain insights to:
- Organised solicited data collection systems, focusing on PSPs from the PV perspective.
- Key insights from the updated ICH E2D guideline in line with solicited post-approval safety information management.
- Key elements of PSP design which may impact PV processes and compliance obligations.
- How solicited safety data from PSPs must be handled: from PV process set-up and cross-functional collaboration to PV training, quality and compliance.
- Common PV challenges in PSP and how to control them through governance, process design, and monitoring.
- PSP implementation within homecare programes: from call center, nurse educator interactions to high-quality PV data.
- Oversight obligations for outsourced PSP vendors.
Who should attend this webinar?
- Pharmacovigilance Professionals (QPPVs, PV Managers, PV Specialists).
- Homecare programme coordinators overseing vendor compliance in handling of solicited data.
- Compliance and Quality Assurance specialists supporting commercial operations.
- Anyone involved in planning or managing organized data collection system, focusing in PSPs.
Language: English
Duration: up to 30 min.
The webinar is free of charge.
Have any questios? Feel free to contact us!
