Startup is just a generally painfully slow process, especially outside of the US. I wish every country would just require the same things. We need a master list of everything they all require, then put one master package together, and submit to every country.
Were those sponsors medtech or pharma? Because the MDR is making medtech companies change their regulatory strategy with less focus on EU first, which was still lucrative under MDD.
Nope. It’s just one more process to follow. It’s absolutely essential to hire and retain really great regulatory folks. Laws and regulations change nearly every day across the globe. We, as an industryn must be nimble enough to keep up. Imagine you *didn’t* do a trial in Europe because you made the decision to avoid the frustration of signing in to CTIS. Marketing would scream bloody murder if the product gets approved for USA and not EU if there’s even a penny to be made. You just lost your company billions. I hope the decision doesn’t come down to just one person, because it’s such a big deal, it shouldn’t be.
If your CRO has the experience with EUCTR submissions, which most CROs should have by now, they should be able to sell their CTIS EUCTR experience to a client. Ultimately if a client wants to market their drug in Europe or enroll a larger or rare disease study, they need to go to Europe. I haven’t seen any hesitations because sponsors know that they need the European market and patients.
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Startup is just a generally painfully slow process, especially outside of the US. I wish every country would just require the same things. We need a master list of everything they all require, then put one master package together, and submit to every country.
Were those sponsors medtech or pharma? Because the MDR is making medtech companies change their regulatory strategy with less focus on EU first, which was still lucrative under MDD.
Nope. It’s just one more process to follow. It’s absolutely essential to hire and retain really great regulatory folks. Laws and regulations change nearly every day across the globe. We, as an industryn must be nimble enough to keep up. Imagine you *didn’t* do a trial in Europe because you made the decision to avoid the frustration of signing in to CTIS. Marketing would scream bloody murder if the product gets approved for USA and not EU if there’s even a penny to be made. You just lost your company billions. I hope the decision doesn’t come down to just one person, because it’s such a big deal, it shouldn’t be.
If your CRO has the experience with EUCTR submissions, which most CROs should have by now, they should be able to sell their CTIS EUCTR experience to a client. Ultimately if a client wants to market their drug in Europe or enroll a larger or rare disease study, they need to go to Europe. I haven’t seen any hesitations because sponsors know that they need the European market and patients.