Pre-Conference Courses

Winning Strategies for PV Audits: Compliance, Inspection Readiness & Risk Management

An Interactive Masterclass on Inspection Excellence and Global Pharmacovigilance Compliance

Coordinated by ISoP Latin America, this 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.

Target audience: 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, Auditors and Inspection Readiness Leads

Learning Objectives: By the end of this workshop, participants will be able to: 

• Understand global PV audit and inspection expectations, Apply risk-based approaches to PV audit planning and execution, Identify critical compliance vulnerabilities and inspection triggers, Develop effective CAPA and remediation strategies, Strengthen inspection readiness programs, Manage health authority interactions confidently, Interpret GVP Module IX requirements in practical scenarios, Improve audit communication, documentation, and governance.

 

Course Faculty:

José Alberto Ayala | Pharmacist & Global PV Expert.
Amal Arafah | Expert Pharmacovigilance inspector.
Dra. Pamela Ramirez | Associate Director Global Patient Safety Astrazeneca.
Gelida Barboza | LATAM Regulatory Intelligence & PV Expert.

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.

Course Faculty:

Ryan Walker (ISoP Europe Chapter, UK)
Angela Caro Rojas (Chair ISoP 2026, Colombia)
Felix Arellano (Roche, Switzerland)
Jürgen Beckmann (Drug Committee of the German Medical Association, Germany)
Patricia Zuluaga (UMC, Colombia)
Manal Younus (Ministry of Health, Iraq)
Hager Saleh

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.

Speakers and instructors:

Gloria Giraldo, Health Canada
Monica Tarapués, UMC
Elki Sollenbring, UMC
Ylva Haassum, UMC
Levente Papai, UMC
Salvador Alvardo, UMC
Anna Baumgarten, UMC
Reema Mehta, Pfizer

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.

Course Faculty:

Leah Herity, PharmD, MPH | FDA
Michele Fusaroli, MD, PhD | UMC
Monica Muñoz, PharmD, PhD | FDA
Niklas Norén, PhD, MSc | UMC
Levente Pápai, MD, MSc | UMC

Intercontinental Hotel
Salon Real I and Real II