The UK has long been renowned for its commitment to innovation and progressive regulatory approaches to pharmaceutical development. There were concerns that separating from the European Union would hinder the UK. However, one welcome, if unexpected, consequence of Brexit has been the emergence of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) as an […]
In the field of rare disease innovation, there has been a tendency to put off planning for the EU, perhaps due to concerns over the requirements or uncertainty as to how to navigate its complex, multi-national landscape. This has, unfortunately, led many sponsors to see “Europe as a problem for later” (or “a problem for […]
While there is much focus on transparency in the Clinical Trial Regulation, it’s important that sponsors understand their data transparency obligations for trials that were conducted in the EU and that will be wrapped up under the Clinical Trial Directive. Sponsors are expected to ensure results from those studies that do not need to transition […]
The Clinical Trials Regulation (CTR) has added some complexities for non-EU sponsors, including with regard to the role of the legal representative. Sponsors who are not based in the EU must appoint a representative within the EU to act as a legal representative. While this has always been a requirement, under the CTR the legal […]
Before making a submission to the CTIS, sponsors transitioning clinical trials previously approved under the EU Clinical Trials Directive must take several preparatory steps. These can be time consuming and are not always well-understood so it’s important that you take time to prepare yourself before making the transition. To get started, you will need to […]
There is a lot for sponsors to think about before they can even start transitioning their clinical trials to the Clinical Trial Regulation (CTR) and accessing the various portals. First, there are practicalities of how they will manage their ongoing studies to ensure they are suitable to transition to CTR. While this is something most […]
Why IDEA set out to provide sponsors with a trusted, independent EU legal representative While the Clinical Trials Regulation has clarified the role of the legal representative, IDEA Regulatory’s founder Dr Francisco Harrison recognised early on that it was more complicated and involved than many sponsors and CROs interpreted it to be. Having supported clients […]
Despite having talented teams, small companies are forced to work with limited resources and access to specific expertise. They often lack the resources and experience in navigating specific regulations, the nuances of working in different countries and have limited time to spend on regulatory intelligence. Working with a regulatory expert who is familiar with your […]
It’s hard to consider a bright side to the current coronavirus pandemic the world finds itself in, but the delays and temporary suspension of many clinical trials do present an opportunity to step back and address gaps in many trial processes. The question, then, is how can you use this time efficiently and effectively to […]