This webinar explores the often overlooked but critically important intersection between Medical Information (MI) and Pharmacovigilance (PV). While both functions contribute to patient safety and regulatory compliance, gaps in communication, processes, and governance can create significant unseen risks. Using real world examples, volume pressures, and regulatory expectations, this session illuminates where breakdowns commonly occur and how organizations can proactively prevent them.
Attendees will learn how MI serves as an early signal detection channel, why volume and operational strain magnify compliance risk, and how misalignment between MI and PV can lead to delayed escalations, inconsistent documentation, or missed reportable events. The session also highlights strategies for building sustainable, scalable MI/PV models that withstand portfolio growth, global expansion, and increased regulatory scrutiny.
Learning Objectives
- Understand where MI and PV workflows intersect and why misalignment can create hidden compliance risks.
- Identify common operational and documentation gaps that lead to delayed escalations, missed AEs, or inconsistent case processing.
- Learn practical strategies to strengthen integration between MI and PV, including governance models, training, workflows, and oversight.
- Understand regulatory expectations, common inspection findings, and best practices for audit ready MI PV processes.
- Explore how to build scalable, sustainable models that support organizational growth without increasing risk.
Who Should Attend?
- Medical Information professionals
- Pharmacovigilance and Drug Safety personnel
- Quality, Compliance, and Regulatory Affairs teams
- Clinical Operations and Medical Affairs leads
- Safety governance and risk management stakeholders
- Any organization with externally supported MI or PV vendors
- Head of Clinical Operations
- Chief Medical Affairs
- Head of Safety
Audience Learning Level
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.
Proof of Attendance
A certificate of attendance can be downloaded from the RAPS Learning Portal following the event.
Questions
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].
Speakers
Hrvoje Macek
