The Education Day is sponsored by Uppsala Monitoring Centre (UMC)
08:00 – 09:00
Registration
09:00 – 13:00
Training Course 1: Pharmacovigilance at the Community and Hospital Set up or Training Course 2: Audits and Inspections- preparing your PV Emergency Kit
Pharmacovigilance at the Community and Hospital Set upAudits and Inspections- preparing your PV Emergency Kit
Pharmacovigilance in Community and Hospital Settings: Strengthening Detection, Reporting, and Patient Safety
Synopsis:
Prioritizing patient safety at the community pharmacies and hospitals, empowering PV focal persons to identify and report AEs to the National Centre:
- Understand the principles and importance of pharmacovigilance
- Detect, assess, report, and prevent adverse drug reactions (ADRs)
- Implement pharmacovigilance systems in hospital and community settings
- Improve patient safety through effective surveillance
Target Audience:
Healthcare professionals and pharmacovigilance focal persons working in hospitals, community pharmacies, primary healthcare facilities, and public health services.
Workshop Aim:
To strengthen the capacity of healthcare personnel in hospital and community settings to identify, assess, report, and help prevent adverse events and other medicine-related problems, while improving local pharmacovigilance systems and patient safety across diverse African settings.
Learning Outcomes:
By the end of the workshop, participants will be able to:
- Explain the principles and importance of pharmacovigilance
- Identify reportable medicinal products-related safety problems
- Write and send high quality, assessable reports
- Propose practical steps to strengthen PV in their own setting
09:00–09:30 Opening and Introduction
- Welcome, Ice breaker (Word cloud of countries, Expectations)
- Objectives
- Workshop structure and relevance for African settings (common challenges)
- Minimum functions of a practical pharmacovigilance system in frontline settings
09:30–10:40 Session 1: What Should Be Detected and Reported?
Part 1 — What to detect and report (20 min):
- Definition and key elements of each type of reportable ICSRs, outlining reporting principles, including ADR vs AE classification, use of SmPC, minimum ICSR requirements, seriousness vs severity, causality assessment, medication errors, and preventability, emphasizing complete reporting to support signal detection
Part 2 — Hands-on work (50 min)
- Two-pass workshop evaluating two ICSRs per table — each table working different cases on country-specific paper forms — assessing completeness, assessability, and preventability against a structured checklist. Then each group will briefly present their findings.
10:40 – 11:00 – Coffee break
11:00 – 11:45 Session 2: Building Practical PV Systems in Hospitals and the Community (3 presentations) describing Iraqi PV Model, Namibia, Community Reporting presentation (Kenya)
- Iraqi PV Model: PV focal persons and local structures, functions, evaluation, and follow-up (by Dr. Manal M. Younus – 12.5 minutes)
- Namibia PV Centre: Promoting reporting by healthcare professionals and patients and MSW (12.5 minutes)
- Kenya: Common barriers and practical solutions for community reporting (by Karen Rotuk – 12.5 minutes)
- Q&A session (7.5 minutes)
11:45 – 12:25 Session 3: Workshop on building PV system
Where participants will be given blocks (each one representing core or additional function/activity) that make up the body of effective system.
12:25–12:45 Session 4: Beyond Individual Case Reporting: Broader Safety Surveillance
- Kenya presentation of expansion beyond traditional pharmacovigilance to also address poison information cases (by Dr. Dorothy Aywak – 12.5 minutes)
- Product quality surveillance and broader patient safety links (by Nadine Sabati – 7. 5 minutes)
12:45–13:00 Closing and Action Planning
- Key take-home messages (5 Messages)
- What participants can implement immediately in their own settings (Slido)
- Final reflections (Volunteer Speakers)
Audits and Inspections- preparing your PV Emergency Kit
Pharmacovigilance (PV) audits and inspections are essential mechanisms for ensuring compliance with regulatory requirements and maintaining robust patient safety systems. Organizations are increasingly expected to demonstrate continuous inspection readiness, effective documentation practices, and the ability to respond efficiently during regulatory inspections.
This interactive training workshop is designed to strengthen participants’ understanding of the full inspection lifecycle — from preparation and inspection management to post-inspection corrective actions. Through presentations, practical discussions, role plays, and case-study workshops, participants will develop practical strategies for building and maintaining a “Pharmacovigilance Emergency Kit” to support inspection readiness.
Facilitators:
- Ahmed Hegazy
- Kennedy Odokonyero
- Thuli Makhene
- Nimisha Kotecha
- Adela Ashie
Learning Objectives
By the end of this training, participants will be able to:
- Explain the purpose and types of pharmacovigilance audits and inspections.
- Identify key requirements for inspection readiness and preparation.
- Develop components of a Pharmacovigilance Emergency Kit.
- Demonstrate effective communication and documentation practices during inspections.
- Apply appropriate approaches for responding to inspection findings and developing CAPA plans.
- Strengthen organizational readiness for regulatory audits and inspections.
Target Audience
This training is intended for:
- Pharmacovigilance professionals
- Regulatory affairs personnel
- Quality assurance staff
- Pharmacy students and interns
- Clinical research and patient safety personnel
- Public health program staff involved in medicine safety monitoring
09:00 – 09:15 Opening Session
Welcome remarks, overview of training objectives, participant introductions, and a brief expectation-setting exercise to identify participant learning goals and concerns related to inspections.
09:15 – 10:15 Session 1: Pre-Inspection Readiness
20-minute Introduction: Overview of inspection preparation processes, inspection triggers, essential documentation, staff readiness, and the Pharmacovigilance Emergency Kit. 40-minute Case Study Workshop: Participants assess organizational readiness and identify inspection preparation gaps using practical case studies.
10:15 – 10:30 Coffee break
10:30 – 11:30 Session 2: Managing the Inspection Process
20-minute Introduction: Overview of the inspection process, team roles and responsibilities, communication strategies, and best practices for interacting with inspectors. 40-minute Case Study & Role Play: Participants practice responding to inspection scenarios, interviews, and document requests.
11:30 – 12:30 Session 3: Post-Inspection Activities & CAPA Development
20-minute Introduction: Understanding inspection findings, root cause analysis, CAPA principles, and maintaining continuous inspection readiness. 40-minute Case Study Workshop: Participants develop CAPA plans and response strategies based on simulated inspection findings.
12:30 – 13:00 Wrap-up
Summary of key lessons learned, participant reflections, evaluation, and closing remarks. Participants identify practical actions they intend to implement following the training.
Training Methodology
The training will use a highly interactive approach combining:
- Presentations
- Group discussions
- Case studies
- Role plays
- Workshop exercises
- Participant reflections and experience sharing
Expected Outcomes
Following the training, participants are expected to:
- Improve their understanding of inspection readiness principles.
- Enhance confidence in handling PV inspections.
- Strengthen documentation and communication practices.
- Develop practical tools for inspection preparedness and response.
- Apply CAPA principles effectively following inspections.
13:00 – 14:00
Lunch
14:00 – 17:00
The afternoon session will be hosted by Uppsala Monitoring Centre where all the delegates will come together for this session
Effective Communication in Pharmacovigilance
Presenter & moderator:
Federica Santoro, Communications Officer, Uppsala Monitoring Centre
Co-moderators:
- Matthew Barwick, Communications Officer & Video Producer, Uppsala Monitoring Centre
- Graeme Nadasy, Outreach Lead, Uppsala Monitoring Centre
Why does good communication matter in pharmacovigilance and what are its essential elements? In this workshop, we will practice how to define target audiences, how to choose the appropriate channels to reach them, and how to adapt messages to the medium of communication.
To prepare for the afternoon session on ‘Effective communication in pharmacovigilance’, we encourage you to take Uppsala Monitoring Centre’s online course on ‘Essentials of pharmacovigilance communications.’
Link: https://learning.who-umc.org/visitor_catalog_class/show/95299
The course is self-paced and will take about an hour to complete. It is not mandatory for the workshop, but it will help you make the most of the session. Those who complete the course by Sunday, 10th May will receive a small present at the UMC booth – so sign up now and see you in Windhoek!