The Scientific Committee of the 24th ISoP Annual Meeting invites abstracts to be submitted for either oral or poster presentation related to the subjects of pharmacovigilance and drug safety.
Abstracts are summaries of the overall goal of an offering and the specific ideas or concepts that will be presented, including outcomes and implications for practice.
General Guidelines
- Abstracts must be submitted online via the abstract management system before the final submission deadline of 2nd of June 2025.
- Please note that abstracts sent by fax or e-mail will not be accepted.
- Abstracts must be submitted in English only and consist of five sections as indicated in the table below “Abstract Layout & Formatting Instructions”.
- An abstract can be submitted as an Oral or Poster presentation.
- The number of submitted abstracts is limited to 3 abstracts per presenting author.
- Up to 15 authors can be submitted for an abstract (including the presenting author).
- The presenting author is selected first; other authors can be added only when the presenting author is submitted. However, the author order can be changed if needed by swapping the names in the list \of the authors.
- The first name in the author list is always considered to be the main/lead author, and the presenting author should be marked.
- After the submission deadline, all abstracts will be automatically considered to be fully submitted and will proceed to peer review.
- All accepted abstracts will be published in Drug Safety, ISoP official journal. It is highly recommended to check the abstract for correct spelling, punctuation, grammar, and formal structure before submitting.
- The organizer reserves the right to edit abstracts, if necessary, prior to the publication in Drug Safety.
- This year’s Meeting intends to provide original and high-quality sessions focused on educational content that is free from commercial influence or bias. We request all presenters to cooperate with this by declaring during the abstract submission process that the abstract is unpublished and original material and fill the conflict of interest form.
- Please read the abstract formatting guidelines carefully.
Abstract Layout & Formatting Instructions
Abstract Example
Title: Pharmacovigilance Assessors’ Experiences Interacting with Narrative Fields in Spontaneous Reports: An Exploratory Interview Study
Introduction: In pharmacovigilance (PV), structured data elements or adverse event reporting play an important role but may not capture all relevant details, such as the patient’s full clinical course or other contextual information. The narrative fields (Narrative Case Summary and Relevant medical history, according to ICH E2B R3), can provide a more detailed account of the adverse event, offering important insights not reported in structured data fields.
Objective: To explore how and why pharmacovigilance assessors interact with the case narrative fields in spontaneous reports to better understand their challenges and needs, paving the way for future developments and support.
Methods: We conducted semi-structured interviews with five PV specialists, three pharmacists and two medical doctors, who had an average of 14 years of hands-on experience working with signal detection and assessment. The participants were all purposively selected from four national regulatory pharmacovigilance centers, covering four geographically and societally different countries. Interviews were recorded, transcribed, and analyzed using thematic content analysis.
Results: We identified four main themes and their respective subthemes: narratives’ content and value; processes utilizing the narratives; challenges assessors face and their needs when interacting with the narratives.
All interviewees viewed the narrative as a source of useful clinical information used in multiple steps of signal management. The narrative provides a ‘‘full clinical picture’’, a chronological storyline that is difficult to obtain from the structured fields. However, assessors often face challenges with uninformative, repetitive, and incomplete narratives despite established guidelines and recommendations on how narratives could be written. This quality issue requires assessors to complement the narrative’s information either using discharge letters or through multiple follow-ups with the initial reporter to better understand the full clinical picture.
Furthermore, assessors struggle with the identification of informative narratives and with the extraction of the relevant clinical information. Assessors’ needs are determined by the main challenges they face when interacting with the narratives or with ways to improve their current manual processes.
Conclusion: Despite challenges in the interaction with case narratives, PV-assessors consider them the hallmark of suspected adverse event reports. Our study stresses the need for a clear implementation of what should be reported in the narratives. The study’s insights highlight the importance of considering assessors’ experiences with the narratives in the development of innovative tools.
References
ICH E2B Implementation Working Group. Implementation guide for electronic transmission of individual case safety reports (ICSRs): E2B(R3) Data Elements and Message specification. Geneva Int Counc Harmon Tech Requir Pharm Hum Use. 2016.
Karimi G, Star K, Lindquist M, Edwards IR. Clinical stories are necessary for drug safety. Clin Med (Lond). 2014 Jun;14(3):326–7.
Disclaimer
Abstracts already published elsewhere or based on full papers that have already been published will not be considered for inclusion.
Advertisements of any products, and/or services are prohibited in the abstract.
Pharmaceutical products should include the generic name and in parenthesis the brand name.
ISoP requests that a high standard of science is followed concerning publications and presentations at all its Annual Meetings and training courses. However, ISoP as a whole its Executive Committee (EC) appointed Scientific Committees, or its members, do not take any responsibility for the completeness or correctness of data or references given by authors in publications and presentations at official scientific meetings. It is not within the remit of ISoP, the EC, or Scientific Committees in particular, to seek clarification or detailed information from authors about data in submitted abstracts. Moreover, it is not within the scope of ISoP and its committees to monitor compliance with any legal obligations, e. g. reporting requirements or regulatory actions.
