Writing this the evening of attending the conference – this year in Brighton, may not be the best time to write the review due to travel disruption! Signal outage at Blackfriar, I had to uber up to London to make the connection home. Not the worst travel story I have by far, but those stories would be for another blog!
Keynote, the conference kicked off with a riveting keynote address by Fabrizio Maniglio (Director Industry and Business Development, Honeywell). Fabrizio gave an insightful delivery of “first principles thinking” by striping away at complex issues back to basic elements to ensure that quality is not just preserved but continuously refined. I especially enjoyed the illustrations of companies who failed to thrive (a healthy reminder) and that it takes a team of different thinkers (historian, innovator and challenger) to bring forth a successful project.
Informative Regulatory Update by Chrissy Cochran, Director at the Office of Bioresearch Monitoring Inspectorate, FDA. The update was peppered with good humour, especially given the political voting coinciding with the conference! But what struck me about Chrissy’s update is that there was a clear message of offering support and communication channels should there be questions. Whether this is input to help resolve a dispute that a Sponsor is having with an Investigator site (a common theme seemed to be that oncology sites are refusing Sponsor/Monitor visits in ICH-GCP studies) or perhaps location of guidance material – Chrissy seems to be instilling a sense of an open-door policy with options for industry to approach and ask questions. This has certainly always been my experience of the FDA-CVM and something that I have come to appreciate over the years.
