News story: Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

first_imgFor current information see Clinical trials for medicines,A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome. With talks ongoing, we remain committed to reaching agreement in the Autumn. However, it’s our duty as a responsible Government to prepare for all eventualities, including ‘no deal’ and that is exactly what we are doing.Although the Government is working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted. The Government has set up the Medicines Supply Contingency Programme to ensure the continued supply of licensed medicines in the UK in the event of a ‘no deal’ Brexit, read this page for more information.We would encourage organisations running clinical trials in the UK to consider their supply chains for IMPs ahead of the 29th March 2019. Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit that we reach March 2019 without agreeing a deal with the EU.It may be necessary to start making any contingency arrangements ahead of the 29th March 2019 to provide assurance to trial participants and for the trials.The life sciences sector may also wish to consider the relevant technical notices published on 23 August, under the heading ‘Regulating medicines and medical equipment’. If you have further queries concerning IMPs please contact [email protected]last_img read more

West Palm Beach Mayor: City Still Open for Business Despite Outbreak

first_imgWest Palm Beach Mayor Keith James has declared a state of emergency due to the coronavirus in his city, but he told Jen and Bill this morning that doesn’t mean that everything has to come to a screeching halt.WPB Mayor Keith JamesThe mayor says the public library is still open and it has to be because many people need to use the computers there to find work and file unemployment claims.Mayor James says the city commission is still gathering and will hold a meeting on Monday while observing the proper social distancing. While bars are closed, restaurants are still open with reduced, wide-spread seating and delivery options.More than 300 coronavirus cases have been confirmed in Florida with 21 Palm Beach County residents now infected with the virus that has already killed more than 100 people nationwide and eight in the state.The new cases revealed Wednesday in Palm Beach County include a 6-year-old boy, the youngest person to test positive for COVID-19 statewide.Florida health officials said it is not known how he contracted the virus. One of the infected residents is not currently living in the county.In addition to the disturbing news that a youngster is infected, the latest numbers released by the Florida Department of Health show that 328 people statewide are now stricken.Listen to Jen and Bill’s full interview with WPB Mayor Keith James here. only drive-through testing center in Palm Beach County announced it is no longer accepting appointments because it doesn’t have the tools it needs.“Until we receive additional test kits, we are unable to further schedule any testing appointments,” said Yolette Bonnet, CEO of FoundCare, which began swabbing people in the parking lot of its Palm Springs office Monday.DeSantis insisted that more kits would be arriving soon.last_img read more