EMA and FDA Inspections Trailer



hi everyone I hope you guys are having a nice day over in the States I'm actually located in Europe I live in Macedonia I'm an American citizen we moved back as a family in 2007 and I have a lot of experience both hosting EMA and FDA inspections I worked in the United States I'm in Quality Assurance since 1995 so it's 20 years going on so that's a little bit of information about myself so I would just like to get the class started okay so today's class we're going to be talking about similarities and differences between EMA and FDA inspections and the learning objects objectives obviously are what those differences and similarities are I'm also going to talk a briefly about MHRA in serious breach requirements this is very specific to the UK to England itself and then we'll go through some typical inspection kind of findings the agenda today is really we're going to talk about who the regulators are and the focus really is on the Europeans and the Americans Canada is there but we're really not going to be talking about Canada today then we're going to talk about preparation and logistics of the inspections themselves we'll only touch about briefly about how you as a sponsor should prepare then what kinds of things the inspectors are actually looking at during a sponsor inspection what happens during post inspections and then what's going on in the industry today especially with the regulator's themselves and between them so who are the regulator's well we have the US Food and Drug Administration obviously for those of you guys in the United States this should be very familiar then we don't have any not in Europe we have the European Union and European Medicines Agency and we also have the MHRA and the reason that I put them in there specifically is that they are actually the regulatory agency or health agency there although they're also called the health agency or the competent authority those are all similar terms and mean the same thing in the industry so you may have heard all three terms being used and the MHRA inspectors are really the go-to teachers of the rest of the European Union they've had more experience they've been doing inspections a lot more you'll hear a lot about your your companies or your affiliates or your partners having inspections in the UK and so they are really the leaders in thought and in processes so what do we think about one evening think about the inspections themselves well there's certainly lots of different types of inspections there's good manufacturing practices there's good vigilance practices but we're going to focus today on good clinical practices and so with regard to all of the agencies its what are what is the intent of the inspection and basically it's to ensure that the studies are conducted not only to the local regulations and the global guidances that are out there but also to protect the rights safety and welfare of human research subjects and this is obviously typical and we we should all know this when they do the inspection they're really looking to make sure that the data can support the sponsor systems and the application so a lot of the inspections have been pre approval the United States we have the new drug application NDA once that's submitted for marketing approval in Europe we call it a marketing approval application or an maa so there's some terminology differences but basically it's the agencies are going to come out and inspect you as sponsor of this study and inspect your sites that have done the studies on your behalf and does the data support what you your claims are in terms of efficacy and safety so what are the regulations and I'm not going to go into in depth in this you can obviously go to the Google and look up the Code of Federal Regulations for the FDA you know fda.gov you could Google EMA and get the directives and so but what's the differences and yet with the FDA they put out draft guidances or rasp things that are gonna go into law and ask for feedback from industry EMA does the same as does the MHRA the EMA they don't actually post any laws they're called directive and what the European Union states are supposed to do is apply those directives into local legislation so they have each number state and there's 28 of them and they include countries such as Germany France me and so on they have one year from the time that the directive is issued to make it into local legislation and this is what the local inspectors then need to follow as well as what the investigators the clinical trial investigators need to adhere to once they're put in place we do have IC h e6 as guidances and a lot of the categories and information within IC h are actually adopted into those directives with the MHRA their laws are actually called statutory instruments and they're numbered and if you you could also go and look up that information online as well

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