Reference Safety Information (RSI) from The Clinical Trial Facilitation Group (CTFG)

Understand how to implement and manage the RSI Q and A guideline

  • 17. Jan 2019

1 day course

English

2.500,- DKK ex VAT
(app. 336,- EUR ex VAT)

Summary

This is your opportunity to take active part in an open, informal discussion on how to implement and manage the CTFG Q&A Reference Safety Information (RSI) document. Share your questions and experiences with colleagues and other stakeholders. 

The Clinical Trial Facilitation Group (CTFG) published their Reference Safety Information (RSI) Q&A document in November 2017. The document was developed to provide clarity to sponsors about the expectations of the EU national competent authorities in relation to the RSI for determination of SUSARs for expedited reporting and annual safety reporting in clinical trials.

The publication of the Q&A followed detailed discussions between national competent authorities and sponsors, which arose from clinical trial application and substantial amendment procedures, as well as GCP inspections.

A transition period of one year (1/1 – 31/12 2018) were granted for sponsors to update the RSI section of the Investigator’s Brochure (IB) to comply with the procedures set out in the Q&A.

The recommendations outlined in the Q&A are strictly enforced by the EU national competent authorities from 1 January 2019.

In this seminar you will meet key stakeholders and learn the Clinical Trial Facilitation Group‘s thoughts on the requirements in the RSI Q&A guideline, and how these are expected to be handled by the competent authorities. You will learn how marketing authorization holders have coped with the Q&A and listen to their experiences on the implementation so far. Finally, you will have the opportunity to discuss and learn from the different approaches taken by the health authorities and MAHs.


Course leaders

Birgitte Scharling, PV Policy Expert, Novo Nordisk A/S, Denmark

Michala Lexner, Senior Principal Safety Advisor, LEO Pharma A/S, Denmark

Lecturers

Smita Robinson, Director, IB BPO Head, Pfizer Inc., United Kingdom

Marie Aavang Geist, Head of Clinical Safety, Orphazyme ApS, Denmark

Elena Prokofyeva, Head of Drug Safety Unit, Federal Agency for Medicines and Health Products, Belgium
 

Keywords

Reference Safety Information (RSI)
The Clinical Trial Facilitation Group (CTFG)
Q&A-reference safety information guideline

What you will learn

  1. To better understand the CTFG’s thoughts behind the requirements in the RSI Q&A guideline, and how these are expected to be handled by the competent authorities
  2. How marketing authorization holders have currently coped with the Q&A and their experiences from the implementation
  3. Which different approaches that have been taken by the health authorities and MAHs

What your company will get

  1. An employee who is up to date and understands the CTFG’s thoughts on the requirements in the RSI Q&A guideline
  2. An employee who can approach the challenges that the RSI guideline might cause now and in the future
  3. An employee who can play an important role in any team dealing with Reference Safety Information (RSI)
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Programme Director Ann Jelert Kristensen at +45 39 15 09 52

Send an email

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