Introduzione
Advanced Safety Management in Clinical Trials under CTR 536/2014
Many sponsors and academic groups have been navigating the evolving landscape of clinical trial safety in the European Economic Area (EEA) since the EU Clinical Trials Regulation (Reg. (EU) No. 536/2014, EU CTR) came into force.
Yet, ensuring a trial is authorized or transitioned in CTIS is only the beginning.
The EU CTR’s safety provisions reach far beyond initial submissions, fundamentally shaping ongoing safety management, reporting, and operational processes throughout the trial lifecycle.
Are your teams confident in distinguishing between IMPs and AxMPs, and in applying the latest definitions for adverse events and serious adverse reactions?
Do you know how to construct, update, and implement Reference Safety Information (RSI) in line with both regulatory and operational realities?
Are your safety reporting workflows, risk mitigation strategies, and communication plans robust enough to withstand regulatory scrutiny and inspection?
Programme
This hands-on, advanced training goes beyond regulatory theory to focus on the “how” of implementing CTR safety requirements within sponsor organizations—whether commercial or academic.
Participants will gain practical insights into:
- Product categorization and definitions: Navigating the nuances of IMPs, AxMPs, and protocol-mandated therapies.
- Adverse event and SUSAR reporting: Applying definitions, managing grey areas, and ensuring timely, compliant submissions.
- Reference Safety Information (RSI): Building, updating, and using RSI (IB vs. SmPC), including challenges for non-commercial sponsors.
- Frequency calculations and population-specific requirements: Structuring RSI tables and calculating event frequencies for diverse trial populations.
- Risk mitigation and safety profile communication: Embedding risk management in protocols and IBs, and keeping investigators informed.
- Submission and implementation processes: Harmonizing IB/RSI updates, aligning with CTIS workflows, and managing multi-trial portfolios.
- Annual Safety Reports (ASR) and DSUR: Meeting format, content, and submission requirements for all product types.
- SUSAR reporting and data protection: Mastering reporting standards, unblinding in line with the latest guidance.
At the end of the course, participants will have the opportunity to ask questions and seek clarification on any of the topics covered.
This open session is designed to address specific concerns, deepen understanding of complex regulatory issues, and ensure that all participants leave with practical, actionable knowledge for their roles.
Professionals involved in the planning, preparation and review of the documents related to clinical trial applications and/or substantial modifications including documents such as Investigator’s Brochures, protocols, Annual Safety Reports, etc.
Professionals who are actively involved in preparation of their organizations to the CTR (EU) No 536/2014 or whose working procedures will be impacted by it.
In particular: Drug Safety and Pharmacovigilance department, Regulatory Affairs department and Quality and Compliance department (e.g. medical writers, pharmacovigilance writers, pharmacovigilance officers, pharmacovigilance managers, QPPVs, safety physicians, managers regulatory affairs and medical evaluators/advisors, document quality and compliance managers).
Participant’s experience
Participants should have a basic understanding of the EU CTR framework and be familiar with the main concepts addressed in the CTR Q&A document.
Interactive discussion with participants
Docente/i
Elena Prokofyeva
Elena Prokofyeva holds a research doctorate from the University of Tuebingen, Germany. She additionally holds a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden.
Dr. Prokofyeva joined the FAMHP in 2016 as a drug safety expert. Currently, she is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. Prior to joining FAMHP she conducted research at Inserm, Paris and worked at a pharmaceutical consulting company in London. Her clinical, research, and industry experience spans a number of topics: drug safety, epidemiology, ophthalmology, cardiovascular and metabolic diseases, health services research, mental diseases, and addictions. She represents Belgium in a safety subgroup of the CTFG. Dr. Prokofyeva initiated and led an update of the Q&A-RSI document within the CTFG which was published in November 2017. She also is actively involved in preparation of CTR Q&A document, and a best practice guide prepared by the CTFG. In addition, she is a part of the working group organized by the European Commission for preparation of an implementing act for the CTR. Dr. Prokofyeva is also part of GCP IWG subgroup in charge of ‘DMC guideline revision’.
Online Training – 1 module
14 May 2027 from 9:00 am to 1:00 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 23/04/2027)
Ordinary: € 620,00*
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.
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.
