The EUropean Federation for Exploratory MEdicines Development (EUFEMED, www.eufemed.eu) is a not-for-profit association that aims to improve the early phase clinical drug development process in Europe [1].
On the 19th September 2018, EUFEMED organised a meeting in Leuven, Belgium entitled ‘The new FIH EMA guideline: Disruptive or constructive?’ to provide a forum to discuss their operational impact. The revised EMA Guideline on strategies to identify and mitigate risks for first-in-human (FIH) and early clinical trials with investigational products was published on 20th July 2017, coming into operation on 1 February, 2018 [2]. As such, it was implicated that many early-phase stakeholders will have gathered first-hand experience of working within the guidelines and could now draw an opinion on its overall value.
This well-attended congress was organised to provide a formal opportunity to harvest learnings in a structured setting that each of the stakeholders may have obtained and insight into any difficulties that may have arrived from the updated early recommendations. Representatives were present from the pharmaceutical industry, clinical research organisations and academia across Europe, as well as officers from all the major regulatory agencies. The meeting was opened by ex-EUFEMED president and local host, Prof. Jan de Hoon (pictured), who provided an overview of comments on 'Concept paper on the revision of the ‘Guideline on strategies to identify and mitigate risks for first-in-human (FIH) clinical trials with investigational medicinal products’ (EMA/CHMP/446302/2016) [2]. A unique opportunity was provided to assess the impact of the day's interactions through the use of a live electronic voting system. And these opinions on the guidelines were compared with the findings of a survey on the opinions of the wider EUFEMED membership that was conducted earlier in the year.
The congress was opened by a summary of the current early phase landscape as seen by each of the member regulatory agencies. The audience was invited to directly interact with the panel of regulators, leading to fruitful discussions to identify possible future risks for those taking part in first-in-human and early clinical trials and hopefully mitigate them. When it came to the final voting, determining the overall 'opinion' on the guidelines, the majority of attendees (51%) felt that they included both constructive and disruptive aspects, whereas nearly half (48%) felt that they were broadly constructive. Stefano Possano of the European Medicines Agency summarised the opinion of the majority of attendees when he said, "This kind of forum is required to avoid misunderstandings in the interpretation of the first-in-human guidance, we should come back and reconvene more regularly."
The EUFEMED executive thanks attendees and speakers for contributing to the great success of this forum.
ive years ago I was lucky enough to be involved in a project that resulted in publications
I am continually reminded that I must work toward better relationships with my sons than the one I had with my dad.
In the past, Halloween has meant the end of the crop and the start of the dark, cold winter.
We all need heroes - people who can champion our cause - helping the world to understand our rationale
Rational Vaccines (RVx) announces MHRA Innovation Licensing and Access Pathway (ILAP) approval for their live attenuated.
The proceedings of the Association for Human Pharmacology in the Pharmaceutical Industry (AHPPI)
I am shamelessly referencing our Insider’s Insights (IIs) to Dr Who’s TARDIS – our latest edition
Concerns about readiness of the European Medicines Agency’s (EMA) Clinical Trials Information System persist as the.
Scientific knowledge should be accessible to all and if you are those communicating science
Finding the best vehicle in which to publish your research findings is a perennial challenge.
Have you seen our latest Insider's Insight on Case Reports? Once a staple of medical journals,
Welcome to the seventh issue of the Refractory Asthma Stratification Programme (RASP-UK) newsletter
I have never been great at conferences. People don’t believe me but I am painfully shy and far too worried about what.
It was encouraging to see so many partners at the 2017 General Assembly meeting last December
The clinical stage biotechnology company developing breakthrough therapies for patients suffering with cancer,
Since 2013 we have been sharing our understanding on key issues with friends and clients via our Insider’s Insights.
The UK's world-class human challenge study gives us new information about SARS-CoV-2 cases that were mild in 36 healthy.
We recently encouraged writers (of all kinds) in our recent Insider’s Insight to experiment with large language.
Investigator sites are very important to clinical studies because they make sure that new drugs are safe and work well.
The largest pharmaceutical companies not surprisingly rely on the largest contract research organizations
Experience at Niche has taught us that clinical study protocols are born in the white-hot fire
Every year, a huge amount of scientific data is released. It's out there, but how do you find it?
Frights create a happy Halloween by providing the thrill of fear in a controlled and safe environment, turning what.
Get our latest news and publications
Sign up to our news letterResources
Social
Contact us
Address
Niche Science & Technology
Unit 26 Falstaff House
Bardolph Road
Richmond TW9 2LH
United Kingdom
