This webcast will show you how to turn regulatory intelligence into coordinated local action through risk-based impact assessment, stronger global-local governance and practical implementation across markets.
Regulatory intelligence has traditionally focused on monitoring legislation, guidelines and agency updates. Today, however, the greater challenge is understanding the operational impact of regulatory change and translating it into compliant action across diverse global markets. This webcast will explore how organizations can move from reactive regulatory monitoring to a structured intelligence-to-execution approach. Through practical examples, participants will learn how to assess country-specific impacts, prioritize actions using a risk-based approach, and strengthen coordination between global and local stakeholders to support lifecycle management, market readiness and sustained compliance.
Upon completion of this webcast, attendees will have learned to:
Regulatory affairs professionals involved in regulatory intelligence, global or local regulatory operations, lifecycle management and compliance. The session will also be relevant to professionals working across quality, pharmacovigilance and other functions responsible for implementing regulatory requirements across multiple markets.
Intermediate: Content is designed based upon the assumption that individuals have basic knowledge of the topic(s) and/or demonstrated competence related to the topic(s). Higher-level concepts are introduced during lectures; exercises requiring synthesis and/or application of concepts are incorporated into the activity.
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Contact the RAPS Support Center:
Call +1 301 770 2920, ext. 200 (8:30 am–5:30 pm EST, Monday–Friday) or email [email protected].


Associate Director, Regulatory Registration and Compliance, PrimeVigilance

Director, Regulatory Registration and Compliance, PrimeVigilance
Ljubica joined PrimeVigilance in 2018 and currently serves as director within the Regulatory Affairs department, leading the Regulatory Registration and Compliance unit. She holds a master’s degree in applied chemistry from the University of Zagreb. Ljubica began her regulatory career in regulatory intelligence and later specialized in the EudraVigilance system, with a strong focus on the Article 57 database. During her time at PrimeVigilance, she led the development of a proprietary automation tool for managing XEVMPD data. Her current work includes overseeing ISO IDMP implementation strategies to ensure data consistency and regulatory compliance. Under her leadership, the team delivers end-to-end support for marketing authorization applications and manages the ongoing maintenance of product licenses, helping clients navigate complex regulatory landscapes.

Associate Director, Regulatory Registration and Compliance, PrimeVigilance
Katarina joined PrimeVigilance (former PharmInvent) in 2013 after obtaining her master’s degree in natural sciences, immunology at Charles University in Prague. She started as a scientific specialist/medical writer and has since added the roles of local contact person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS). Through various projects, she gradually moved into regulatory affairs, performing medicinal products dossier management activities. Katarina currently holds the associate director regulatory affairs, MAA, and maintenance role and provides senior oversight in projects involving marketing authorization applications and product lifecycle management in post-authorization. She also acts as a Local Contact Person for Regulatory Affairs (LCPRA) with the State Institute for Drug Control in the Czech Republic.