I'm sure that everyone works hard and tries to do their best. Still, no matter how hard we work, the best thing we can say about our daily grind is that we did our job. However, every once in a while, things come together in a way that makes something stand out from "the norm." What we make isn't always just the sum of its bits.
Don't get too excited, because it's usually the work of a group of people. But it's still great to be a part of something great. A paper I had the pleasure of working on with a group of top professionals in the field was released yesterday in the journal Frontiers in Pharmacology [1]. European Federation for Exploratory Medicines Development (EUFEMED) is a non-profit group that wants to make the process of developing new drugs in Europe better in the early stages. EUFEMED held a meeting in Leuven, Belgium, on September 19, 2018, called "The new FIH EMA guideline: Disruptive or constructive? ", so that parties could talk about how the guideline would affect operations. The updated EMA Guideline on how to find and reduce risks for First-in-Human and early clinical trials with investigational goods came out on July 20, 2017. The idea came from the desire to get sponsors, agencies, and service providers in the pharmaceutical business to talk to each other.
Since the guidelines started to be used on February 1, 2018, it was thought that by the time of the meeting, many early phase parties would have enough first-hand experience to talk about how they thought they would affect things. Over 100 people came to the event. Active-directed polling with the sli.do online tool was used so that the public could decide what would happen on the show. Attendees were polled electronically throughout the meeting. The organisers were looking for their opinion, knowledge, and insights about the guidelines as well as any problems they may have had when they first started working with the updated recommendations.
The meeting was open, and the conversations were helpful, friendly, and lively. While I was taking notes on the meeting, my pen ran out, and the person from the EMA sitting next to me said that he had never seen anyone write so much in one meeting because there was so much "good stuff" being said.
By the end of the meeting, most people agreed that the changes that needed to be made, which were covered by the new rules, had both good and bad parts. The meeting itself was not valuable; what made it useful was the ongoing conversation and networking between groups that might have thought of themselves as being in different "camps." The majority of people agreed that stakeholders need to keep being involved and talking, especially when it comes to important safety problems. This way of doing things lets partners share best practices without being asked.
Because the talks were written down, we now have a useful record of them, and I have something to brag about. As Chairman of the AHPPI, I'm proud of what our members and those from the MHRA who came to the meeting did. Thank you to everyone who helped and took part.
References
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