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.
Registration Fees & Deadlines
Free
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.
Speakers
Hrvoje Macek
Vice President, Pharmacovigilance Services, Clinigen Healthcare
Macek will provide executive level support for this program. He has over 20 years of experience in pharmacovigilance and medical & scientific affairs. Macek led global safety operations, regulatory compliance programs, and medical affairs services across multiple regions. Hrvoje holds a Doctor of Veterinary Medicine degree from the University of Zagreb and is recognized for his expertise in building end-to-end PV frameworks, managing audits and inspections, and driving operational excellence for international clients.
Andrew Barnett
Medical Information Manager Ketryx, Clinigen Healthcare
Barnett is medical information manager at Clinigen, where he oversees the delivery of accurate, compliant, and timely scientific information to healthcare professionals and patients. With over five years of experience in medical information services, Barnett has progressed through roles from associate to specialist before assuming leadership responsibilities. He holds an MSc in Exercise and Sports Science from the University of Birmingham and a BSc in Medical Physiology from the University of Leicester.
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
support@raps.org.