Webinar on Building a Robust Local Literature Screening Framework: Lessons from the Field

Local literature screening is an important component of pharmacovigilance, but its practical implementation can vary considerably across countries, products, and organizations. One of the key challenges is determining whether local literature screening is required, when it should be initiated, and how its scope should be defined without unnecessarily duplicating global literature surveillance activities.

This presentation will explore the practical considerations involved in establishing and maintaining a robust local literature screening framework. Drawing on lessons learned from real-life implementation, it will examine the factors that may influence the need for local screening, including regulatory expectations, marketing authorization status, global literature coverage, availability and relevance of local sources, language, and country-specific considerations.

Particular attention will be given to the decision-making process for initiating local literature screening, defining appropriate sources and responsibilities, ensuring adequate documentation and oversight, and maintaining a balance between compliance, patient safety, quality, and operational efficiency.

Join us on 19 November at 13:00 UTC

Presenter: Ieva Jankauskiene is PV Project Manager combining scientific expertise with operational and project leadership. She brings 8 years of experience across local pharmacovigilance, client management, multi-country coordination, quality oversight and successful project delivery.

Ieva has extensive hands-on experience in local pharmacovigilance operations and multi-country PV project management, with particular expertise in local literature screening, safety information and ICSR handling, local regulatory activities, and oversight of PV processes performed on behalf of Marketing Authorization Holders. Ieva’s combination of practical local PV experience, quality and compliance oversight, client management, and project leadership makes her a strong asset in building robust, compliant, and efficient local pharmacovigilance frameworks across different markets.

By the end of the webinar, participants will be able to:

• Understand the role of local literature screening within the broader pharmacovigilance literature surveillance framework and its relationship with global literature screening.
• Recognize the key triggers for initiating local literature screening, including product and market considerations, local requirements, publication landscape, and potential gaps in global coverage.
• Assess whether local screening adds meaningful value or primarily duplicates activities already performed at global level.
• Apply a structured, risk-based decision-making approach to determine when local literature screening should be initiated and how its scope should be defined.
• Identify critical elements of a robust local literature screening framework, including source selection, search strategy, frequency, responsibilities, documentation, oversight, and periodic reassessment.
• Recognize common implementation challenges and pitfalls encountered when managing local literature screening across multiple countries, affiliates, partners, or vendors.
• Understand the importance of documenting the rationale behind decisions to initiate, modify, continue, or potentially discontinue particular local literature activities.
• Take away practical lessons from the field that can be used to challenge existing processes and improve consistency, efficiency, and oversight.

Who should attend this webinar?

• This webinar is designed for pharmacovigilance and drug safety professionals.

Language: English

Duration: approximately 20 mins.

The webinar is free of charge, register to watch.

Have any questios? Feel free to contact us!