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...this page of the EMA website. It can be considered that the majority of Annex 16 applies to IMPs. Any exceptions to this, or any specific requirements relating to IMPs,...
...to view, but this placed an extra burden on already stretched investigator sites. Protocol-required visits could be done via phone or a video call, so participants could be followed, but...
...out centrally. This is aided by the Agency’s Sentinel system which contains details of all UK Marketing Authorisations, site licences, and Inspections. The scope of the on-site activity has also...
...a company or at a site, including operations and their culture, is essential before agreeing a contract. Failure to properly examine other areas of a business can result in failing...
...minimising the number of site personnel involved in facility tours, and rigorous health screening for symptoms and infections. Inspectors will also comply with any government or site-specific restrictions in place...
...also to investigator sites for all clinical trials involving investigational medicinal products (IMP). With 4 weeks to go until the symposium, I wanted to share with you the latest updates...
...of sites including pre-clinical sites, manufacturing facilities, clinical trial sites, pharmaceutical company offices and medicines distribution sites. With our whole fleet of inspectors grounded, swift action in innovating the way...
...are working on updating our national legislation and associated guidance, so we are thinking about any learnings from the pandemic as we do this. In addition, we are also looking...
...the process can be found on the EMA website European Medicines Agency, London MHRA Audit The audit, from 12th to 16th October, was conducted by a team of 3 assessors;...
