About

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The course will explain the impact of the Clinical Trial Regulation (CTR) (EU) No 536/2014 on the regulatory and assessment procedures for clinical trials in the EU with special focus on safety and pharmacovigilance. The differences between Clinical Trials Directive (CTD) 2001/20/EC and CTR EU No 536/2014 will be outlined. Participants will be able to share and discuss their first experiences with CTR/CTIS. This course will cover the rules for safety reporting, tips and tricks for submission of clinical trial application and the substantial modification, and the ASR. Typical issues and types of requests for further information will be discussed.

The course will address:

  • Safety regulatory and assessment procedures under the CTD, the CTR and in a transition period.
  • Brief introduction to CTIS as a main submission portal.
  • Main point to consider related to CTR Q&A document.
  • Regulatory expectations for a Clinical Trial Application (CTA) submission and modifications during the developmental cycle (Phase I to Phase IV) in safety documents such as Investigator’s Brochure (IB), Reference Safety Information (RSI), protocol.
  • Regulatory expectations for an Annual Safety Report (ASR) submission .

MODULE 1: Safety in clinical trials under the CTR

  • Introduction
  • Difference between Clinical Trials Directive 2001/20/EC and Clinical Trials Regulation EU No 536/2014: changes of regulatory and assessment procedures.
  • Clinical Trial Information System (CTIS): brief discussion of main features and first experiences.
  • Safety reporting in clinical trials: will anything change?
  • Breakout sessions and discussion: Hot topic and new challenges with CTR/CTIS

MODULE 2: Safety/clinical assessment of a CTA under the CTR: what is to expect?

  • Regulatory expectations for a Clinical Trial Application (CTA) submission and modifications during the developmental cycle (Phase I to Phase IV) in safety documents such as Investigator’s Brochure (IB), Reference Safety Information (RSI), protocol.
  • Focus on the CTR Q&A document: frequent issues and tips and tricks to avoid them.
  • What requests for further information will focus on?
  • Breakout sessions, group exercise and discussion: Understanding assessors’ perspective.

MODULE 3: The Annual Safety Report (ASR) and SUSARs assessment under the CTR: what is to expect?

  • SUSAR screening and assessment
  • ASR submission, assessment and regulatory expectations
  • ASR writing: format and requirements
  • Breakout sessions, group exercise and discussion: How to plan and write your ASR

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 Experience

Basic knowledge of drug development, safety and/or pharmacovigilance.

Presentation, hands-on exercises using real life anonymized cases, group discussions with a limited number of attendees.

Lecturers
Elena Prokofyeva
Info

Elena Prokofyeva

Head of drug safety unit at Federal Agency for Medicines and Health Products (FAMHP)

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’.

This online training is divided in 3 modules:

Module 1 | 04 May 2023 from 09:30 am to 12:30 pm CEST
Module 2 | 11 May 2023 from 09:30 am to 12:30 pm CEST
Module 3 | 12 May 2023 from 09:30 am to 12:30 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: € 945,00* (until 13 April 2023)

Ordinary: € 1.155,00*

Freelance – Academy – Public Administration**: € 615,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

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Printable Version
At the end of the training, you will be able to
Risultato atteso
Understand the safety changes in regulatory and assessment procedures under Clinical trial regulation (EU) No 536/2014
Risultato atteso
Identify main changes in regulatory expectations based on review of the CTR Q&A document
Risultato atteso
Know the regulatory guidelines to follow during a transition period
Risultato atteso
Understand the main issues related to a submission of a new IB/RSI or an update of an existing RSI and how to avoid them
Risultato atteso
Understand how to plan a submission and how to structure an ASR
<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p> <p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>
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Safety in Clinical Trial under the Clinical Trial Regulation (EU) No 536/2014