Introduzione
Module VI of the GVP clearly states that competent authorities and MAHs must take all appropriate measures to collect and collate reports of suspected adverse reactions associated with medicinal products for human use.
The management of reports of suspected adverse reactions must be such as to ensure that safety reports are accurate, consistent, verifiable and complete for medical evaluation and submission to the authorities and/or distribution to partners / sponsors.
The objective of this course is to understand the importance of preparing and processing safety reports (SAE/SUSAR and CIOMS forms). The participant will be able to acquire the knowledge and tools necessary to independently compile reports of suspected adverse reactions associated with medicinal products for human use.
Introduction to Pharmacovigilance and Key Concepts
- Overview of Pharmacovigilance
- Definition and importance in drug safety
- Role in clinical trials and post-market surveillance
- Key regulatory bodies (FDA, EMA, ICH)
- Adverse Events (AEs) vs. Serious Adverse Events (SAEs)
- Criteria for classifying AEs and SAEs
- Reporting obligations for SAEs
SAE and SUSAR Reporting Process
- Understanding SUSAR (Suspected Unexpected Serious Adverse Reaction)
- Definition and regulatory requirements
- How SUSARs differ from other AEs
- Reporting timelines and obligations
- Generating SAE/SUSAR Reports
- Key information required for reporting (patient details, drug info, event description)
- Steps in generating SAE/SUSAR reports
- Common challenges in SAE/SUSAR documentation and how to overcome them
CIOMS Form and Its Role in Pharmacovigilance
- Introduction to CIOMS Form
- What is CIOMS and the role of CIOMS form in pharmacovigilance
- Overview of CIOMS I form structure (fields and key components)
- Step-by-Step Guide to Completing CIOMS I Form
- Common mistakes and best practices for completing the form accurately
- Practical tips for data entry and documentation
Hands-on Practical Session and Q&A
- Practical Case Study: Completing an SAE/SUSAR Report and CIOMS I Form
- Walkthrough of a real-life case study to complete the SAE/SUSAR report and CIOMS form
- Q&A and Troubleshooting
- Address participant questions and challenges
- Group discussion on common issues and solutions in SAE/SUSAR reporting
Closing Remarks and Summary of Key Takeaways
Pharmacovigilance Department, Pharmacovigilance Operations, Clinical Operations Department, Regulatory Affairs Department.
Participant experience:
Basic knowledge of Pharmacovigilance concepts.
Slides, hands-on exercises, Q&A.
Docente/i
Nicola Sisti
Master’s degree in Pharmacy at University of Perugia. Continued his post-graduate training with the full-time II° level Master’s degree in Healthcare Management at SDA Bocconi – Milan, where he specialized in healthcare management. Professional experience in Italy and UK at pharmaceutical-biopharmaceutical-biomedical companies, where he worked in pharmacoeconomics, product and project management. Since November 2015, Pharmacovigilance Officer at PM Clinical LTD and since July 2017 Drug Safety Manager at seQure Life Sciences S.r.l. (Business Unit of Arithmos S.r.l.), where he holds the role of responsible for post-marketing case processing activities and clinical studies, analysis and submission of ICSRs in EudraVigilance, monitoring and quality control of medical-scientific literature, deputy QPPV, Local Responsible Person, production of KPIs, drafting of SOPs-WIs and support in the drafting of PSURs-RMPs-ACOs. Also at seQure Life Sciences S.r.l. held the role of GVP Auditor and Case processing Coordinator, coordinating the PV operations of the case processing team. Currently holds the role of PV Operations and EMA CTIS Management Manager at Fidia Farmaceutici S.p.A. and carries out PV operations and data management of the Safety database.
Marco Anelli
Marco has a medical degree from the University of Milan, specializations in Medical Statistics and Clinical Pharmacology from the University of Pavia and an international master’s degree in health economics and pharmacoeconomics from the University of Pompeu Fabra in Barcelona, plus formal training in Data Science and Artificial Intelligence. In the last few years, he has extensively worked in the fields of pharmacoeconomics and health technology assessment. Marco has been a free-lance consultant in Medical Affairs and Pharmacovigilance/ Drug Safety since 2022. Before that, he has been “Head of Pharmacovigilance and Medical Affairs Advisory Services” at ProductLife Group (PLG). As “Deputy Chief Scientific Officer”, always at PLG, Marco has also coordinated all delivery and research projects (internal and on behalf of clients) linked to Big Data, Knowledge Management, Artificial Intelligence and Machine Learning. Previously, Marco was R&D Director at Keypharma, an Italy-based consultancy company (later acquired by PLG), where was responsible for the oversight of all clinical and preclinical aspects of projects run internally and on behalf of clients. Drawing on a career in the pharmaceutical industry that spans more than 30 years, Marco provides expert oversight on a wide range of R&D and Medical Affairs related activities. Marco has participated in and supervised all stages of drug development – from formulation to Phase I-IV and pharmacovigilance. In addition, Marco is a qualified QPPV and has prepared and overseen more than 200 non-clinical and clinical overviews and summaries. Before joining Keypharma and PLG, Marco was Medical Affairs Director at Eurand.
Online Training – 1 module
07 May 2025 from 02:00 pm to 06:00 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: € 545,00* (until 16 April 2025)
Ordinary: € 665,00*
Freelance – Individual – Academy – Public Administration: € 435,00*
* 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.
Barbara Rossi
Training & Quality Manager
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.
