More and more Language Services Providers (LSPs) are entering the regulatory area who, in turn, outsource this work to their in-country network. The people who actually do the label review are removed from the pharmaceutical company or CRO by up to four degrees and the end-client has no visibility at all of who is doing this work.
Read MoreThe complexity of the regulatory approval process for labels increases with each clinical phase, as patient numbers increase, from 10-20 patients in Phase 1 to 100-200 people in Phase II, to as many as 10 000 patients in a Phase III trial. As many Phase III trials are conducted across an increasing number of countries, the complexity of dealing with multiple regulatory agencies is magnified.
Read MoreOver two-thirds of clinical studies are carried out outside of the USA. It is not unusual for Phase III trials, in particular, to be carried out in over 30 countries across five continents. More study sites outside of North America and the UK and EU region are being introduced each year, including in countries like Georgia and Guatemala.
Read MoreAt a press conference in May 2017, Jean-Claude Juncker, outgoing president of the European Commission, quipped “Slowly but surely, English is losing importance”, before switching to French for the main part of his speech. Clearly, he was having a dig about the UK’s withdrawal from the EU, which, by 2017, was already proving to be an exhausting, tedious process for all sides.
Read MoreMost of us will agree that there are some things whose importance should transcend politics and borders. There are some basic human rights, such as safety, protection from harm, access to shelter, food, and medicines.
Read MoreThere are some things that most of us take for granted. If we go to the supermarket, we’ll be able to stock up on essentials, such as bread, Irn Bru and, of course, Monster Munch. If we go to a café, we expect to choose and consume any item on the menu.
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