Learn about fundamental leaderships skills, how these can be applied in a PV context, pathways to leadership in PV, how to lead effectively during challenging situations, and strategies to support your personal leadership development. By the end of the course, you will also be equipped with tools and strategies that you can use to continually hone your approach to leadership.

Target audience: The course is relevant to anyone looking to strengthen their leadership abilities, from students and early career professionals, through to experienced PV specialists.

Objetives: To equip participants with the fundamental skills to succeed in leadership roles in PV and to agree a shared definition of good leadership in PV.

The course will enable participants to detect and assess signals effectively and to apply signal assessment approaches to support transparent and robust regulatory decision making that prioritises patient safety.

Participants may choose to attend part 1 only, or the full-day programme, depending on their learning needs and level of experience. Participants who complete the full-day course and meet the requirements outlined in the end-of-day assessment will receive an official certificate of completion issued by Uppsala Monitoring Centre and ISoP, recognising advanced training in pharmacovigilance signal management.

Target audience: Industry and regulatory pharmacovigilance professionals; Qualified Persons Responsible for Pharmacovigilance (QVs), safety scientists and medical reviewers; researchers and academics working with real-world data and drug safety.

Objective: To equip participants with practical skills in pharmacovigilance signal management, enabling them to detect and assess signals effectively and to support transparent and robust regulatory decision making that prioritises patient safety.

Prerequisites: Before attending the course, participants are expected to complete five online introductory courses that establish the essential concepts and terminology required for effective engagement in the in-person training sessions. Further details on the specific courses will be shared with participants after registration.

Target audience: This course is designed for pharmacovigilance experts across regions, industry professionals, academic researchers, and regulators who work with or have an interest in global adverse event surveillance systems and postmarket drug safety monitoring.

Objectives:

• Describe the frameworks and recent updates governing adverse event reporting to AEMS and VigiBase
• Explain database characteristics, strengths, limitations, and appropriate applications for both systems
• Identify factors affecting reporting patterns over time and their impact on signal interpretation
• Navigate the AEMS public dashboard and apply best practices for data analysis
• Apply innovative analytical approaches, including methods for identifying special populations in adverse event data
• Analyze case examples demonstrating practical applications in global pharmacovigilance.

In todayˇs evolving regulatory environment, Pharmacovigilance (PV) audits and inspections have become increasingly complex, risk-driven, and globally interconnected. Organizations must move beyond reactive compliance and adopt proactive strategies that ensure continuous inspection readiness, effective risk management, and operational excellence.

Learn about audit planning and scope definition, PV system inspections, GVP Module IX compliance, deviation management, CAPA development, regulatory inspection conduct, and audit trail documentation through practical exercises and case studies.
Target audience: This course is aimed at professionals with expertise in Pharmacovigilance Professionals, PV Quality Assurance Teams, QPPVs and Local Safety Officers, Regulatory Affairs Professionals, Compliance Managers, Clinical Safety & Risk Management Teams, CRO and MAH Representatives and Auditors and Inspection Readiness Leads.
Objective: His half-day course will address the planning, conduct, and management of audits and inspections of pharmacovigilance systems, with a focus on ensuring compliance with Good Pharmacovigilance Practices (GVP), global regulatory requirements, and continuous quality improvement.