Vivienne Ben-David, B.Sc. (Pharmacy) PGDip.
Project Manager & Associate Director, Pharmacovigilance ROW
Aside from New Year’s resolutions and a clean sweep, what else should you refresh in 2019?
I politely suggest your understanding of Reference Safety Information (RSI) in the EU.
In Nov 2017, the Clinical Trials Facilitation Group published the Reference Safety Information Q&A document, and followed in March 2018 with a cover note. The latter explains that the recommendations in the Q&A document will be implemented more strictly from the beginning of January 2019.
The RSI future is now. Or is it old news? Well, it’s a bit of both, seemingly.
In 2011, the EU guidance (CT-3) on adverse events and reactions clearly stated that the expectedness of an adverse reaction is determined by the sponsor in the reference safety information (‘RSI’).
More recently, Competent Authorities across Europe have since provided sponsors with detail on what Reference Safety Information is and isn’t. For example, the Investigator’s Brochure is not the RSI; there should be a distinct section in the IB entitled ‘Reference Safety Information’.
The RSI should list serious adverse reactions (SARs) which are considered expected with the investigational product. It should not include SARs observed with any similar products in the same drug group. And note: SARs that have occurred once are generally consider unexpected. You have to provide a robust justification for including those one-timers in the RSI.
Seriously? Absolutely, include only SARs in your RSI; non-serious reactions can be included in a different section.
It’s not hard to understand, but ignore it and you might feel the only heat in wintery Europe.
If you want your clinical trial application to go smoothly or approval of your next IB update – brush up on the details by reading the Q&A, clarify your understanding with your pharmacovigilance colleagues and keep your clinical trial subjects, and your product, on the safe side.