Introduzione
Narrative Writing in Pharmacovigilance - Ensuring Clarity, Consistency, and Regulatory Readiness in Line with ICH E2D/E2B(R3) and GVP Principles
Well-structured narratives contribute to accurate safety case evaluation, expedited reporting, and effective signal detection.
The goal of this training is to develop participants’ capability to prepare high-quality, scientifically sound, and regulatory-compliant safety narratives that meet the expectations outlined in Post-approval safety data management ICH E2D, Electronic transmission of individual case safety reports (ICSRs) ICH E2B(R3) and relevant GVP guidance.
Participants will learn practical techniques for writing narratives that are clear, concise, medically meaningful, and fully aligned with regulatory and inspection requirements.
Programme
Regulatory Foundations for Narrative Writing
- Purpose and regulatory expectations for ICSR narratives
- ICH E2D and E2B(R3) requirements: essential narrative elements
- GVP insights: how narratives support signal detection and risk management
Structure and Content of a High-Quality Narrative
- The narrative as a medical story: logic, flow, and clinical meaning
- Required components: patient history, event chronology, suspect drug(s), concomitant therapy, laboratory results, outcome, and causality
- Writing for clarity and coherence – medical accuracy vs. verbosity
- Handling missing or ambiguous information
Writing Techniques for Clarity, Consistency, and Objectivity
- Use of standard medical terminology and neutral tone
- Avoiding bias, duplication, and inconsistency
- Techniques for summarizing complex data clearly
- Ensuring consistency across multiple narratives within one product or project
- Maintaining compliance with MedDRA and data fields in E2B(R3)
Quality Review and Quality Assurance of Narratives
- Internal quality control (QC) and review checklists
- Role of QC and medical reviewers in ensuring narrative integrity
- Integration of narratives into case processing workflows
- Linking narrative quality to audit/inspection readiness
Throughout the training, practical exercises on Narrative Writing will be carried out, such as:
- Hands-on drafting of narrative summaries from sample case reports
- Structuring information logically from patient history to outcome
- Applying clinical reasoning to assess causality and medical judgment
- Quality and consistency checks to detect and correct common errors
- Group review and feedback to compare outputs and align writing styles
This training course is designed for professionals involved in the preparation, review, or quality assurance of individual case safety reports (ICSRs) and other pharmacovigilance documents where narrative quality is critical. It is particularly relevant for:
- Pharmacovigilance Specialists / Associates responsible for ICSR processing and safety data management
- Medical Reviewers and Physicians involved in case evaluation and causality assessment
- Safety Writers / Medical Writers preparing case narratives and aggregate safety sections
- Quality Assurance (QA) Professionals overseeing compliance and inspection readiness in PV systems
- Regulatory Affairs Personnel supporting safety reporting and submission documentation
- Drug Safety and Risk Management Experts involved in signal detection and risk evaluation activities
- Clinical Research and Medical Information Teams contributing to post-marketing safety documentation
Whether you are an experienced pharmacovigilance professional or new to case processing, this course will provide practical, hands-on guidance to enhance your narrative writing skills and ensure alignment with ICH and GVP regulatory expectations.
Participant experience
No prior formal training in medical writing is required; however, participants should have a basic understanding of pharmacovigilance processes and ICSR case handling.
The course is best suited for professionals who already work, or plan to work, in drug safety, regulatory affairs, or clinical research, and who are familiar with adverse event data and safety databases.
Prior exposure to ICH E2D/E2B(R3) concepts or GVP principles will be beneficial but is not mandatory, as these will be reviewed during the training.
This training is a practical, interactive online workshop combining expert presentations with hands-on exercises to develop participants’ skills in writing clear, consistent, and regulatory-compliant safety narratives.
Docente/i
Liana Kasyan
Liana is the Founder and CEO of ETL Healthcare. Previously she served as the Lead of PV Project at Clinchoice CRO, then became the Head of Pharmacovigilance Department at the same organization. Then she joined NoyMed CRO as a Head of PV and MA department. She always serve as a PV trainer and Subject Matter Expert for PV teams. She is an active member of the WHO Global Patient Safety Network (GPSN) and serves on the Editorial Board of the Journal of Patient Safety and Epidemiology at the Society of Clinical Research and Medical Professionals (SCRMP).
Liana is also a Technical Advisory Board Member at Ancillarie, and a Member of the International Society of Pharmacovigilance (ISoP). As the Global Pharmacovigilance Society Ambassador for Armenia, she contributes to promoting medicine safety awareness and collaboration within the region. Additionally, she serves on the International Editorial Board of the Journal of Pharmacovigilance and Drug Research (JPADR) and is a Board Member of the Armenian Association of Specialists in Evidence-Based Medicine (AASEBM).
Beyond her professional roles, she is also the Co-founder of the “Do not Harm” Health NGO, dedicated to advancing patient safety and public health initiatives.
Online Training – 1 module
30 June 2027 from 2:00 pm to 6:00 pm CEST
Some days before the online training you will receive all details about the connection.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 490,00* (until 09/06/2027)
Ordinary: € 620,00*
Freelance – Individual – Academy – Public Administration: € 390,00*
* for Italian companies: +22% VAT
The fee includes: tuitions, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.
Newsletter
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
