The EU legal representative plays a unique role in the life sciences industry and requires a distinctive skill set – with a background in regulatory affairs and quality assurance, but from inside the good clinical practice (GCP) sphere. Now, with the added complexity of the Clinical Trials Regulation and the Medical Devices Regulation, the role has become even more specific.
With that in mind, IDEA recently recruited a QA expert with experience in all parts of the organisation where stringent management systems are supposed to be in place – manufacturing plants, laboratories, chemical development process, quality, CMC and pharmacovigilance.
“Experience has shown us that the legal representative really needs to understand the ins and outs of how a trial should work in the EU.”
The legal representative needs to stay on top of multiple clinical study questions:
- Who is running the studies?
- How are they being run?
- Who is ultimately responsible for the sponsor’s pharmacovigilance systems?
- Who is managing the patient data?
More and more companies are facing penalties for GDPR breaches, so the legal representative needs to make sure those elements are being properly managed.
Knowing how EU trials work
Experience has shown us that the legal representative really needs to understand the ins and outs of how a trial should work in the EU. They need to understand how to support quality systems and standard operating procedures.
The legal representative requirement, from what I understand, stems from German regulation, where sponsors always need a named person who is responsible if something goes wrong. Many other EU countries supported that idea because you need someone within the jurisdiction to not only be responsible, but to understand what those responsibilities are.
Meeting local standards
Consider, for example, a medical device made in China, India, the United States, Australia or anywhere in the world. However good that device is, it isn’t necessarily made to the standards of an EU country and isn’t inspected by local officers as would be the case for EU-based companies. So, there needs to be something in place to ensure that a product coming into the EU to be tested on EU citizens, is safe, has been built properly, and is being tested appropriately in accordance with EU standards. Furthermore, there needs to be assurance that the company, or representative, who is responsible for the product has proper oversight over what is happening within the jurisdiction in which the product is being tested.
Under the MDR and CTR, our QA to the QA will be laser-focussed on key questions such as:
- What do your quality management systems (QMS) look like?
- How well do you understand the regulations you’re operating under?
- And how was your management system built to facilitate you managing this study in countries outside of your home territory?
Asking the right questions
Quite often, smaller/virtual trial sponsors will need to outsource almost everything. But who is checking that you have outsourced to someone who’s doing it right? How are you qualifying your partners? What return are you getting on those investments?
- Are you going to have a fully compliant study?
- Can your QMS pick up if there’s investigator fraud going on, for example, if an investigator site is not recruiting real patients?
- Is it able to pick up something in the manufacturing process that could cause you problems down the line?
- Are there going to be issues or product recalls?
Indeed, how effective and how much value are you getting out of your vendors in general? Because that’s what your QMS should be able to tell you.
While running a clinical trial in the EU is not significantly different to running one in the U.S., or many other countries, there are 27 countries to navigate in the EU, 24 official languages and cultural differences in every country. It helps if your QA system, and the person providing oversight of that, is able to take all of that into account.