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Preparing for ICH-GCP E6(R2): A Former GCP Inspector Answers Your Compliance Questions


Clinical Trial

As this new rule will have an impact on all stakeholders in the clinical trials process – including study sponsors, contract research organizations (CROs), and investigator sites – it’s important that the guidelines are fully understood before GCP inspectors begin implementing them.

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February 21, 2017 | by Sarah Hand, M.Sc.

On the 14th of June, 2017,* the revised ICH-GCP E6(R2) guidelines will go into effect in the EU. Regulatory agencies around the world – including the FDA, EMA and Japanese Health Authority – are expected to adopt the new Good Clinical Practice regulations.

As this new rule will have an impact on all stakeholders in the clinical trials process – including study sponsors, contract research organizations (CROs), and investigator sites – it’s important that the guidelines are fully understood before GCP inspectors begin implementing them. To help investigator sites prepare to comply with the revised guidelines, cloud-based technology company Intralinks, hosted a webinar on what was changing in ICH-GCP E6(R2), compared to previous versions of the rule.

I had a chance to speak with Gunnar Danielsson, a former GCP Inspector for the Swedish Medical Products Agency and European Medicines Agency, who now helps the industry and academia as an independent consultant.

Danielsson will also be participating in Intralinks’ upcoming webinar, “ICH-GCP E6(R2) – Live Q&A with GCP Inspector and Investigator Site Perspectives.” Register for this webinar by following the link, and feel free to submit your own questions about ICH-GCP E6(R2) in advance of the event.

Once ICH-GCP E6(R2) takes effect, how do you think it will change the perspective of an inspector when they’re doing the GCP audit following these new guidelines?

If you look at what has been added to the R2, apart from added clarification of the requirements of electronic systems, it stresses the responsibilities of oversight both by investigators as well as sponsors and control of vendors. This includes control of data, study staff, documents and the quality systems that should be implemented. I think that the main purpose of the revised regulation is to ensure that you increase the quality of the study by ensuring that all stakeholders – whether it be the investigator, ethics committee, sponsors or CROs – all jointly take responsibility for study quality.

The pharmaceutical industry is very conservative when it comes to how they interpret regulations and guidance. Do you see these changes as part of encouraging the industry to focus more on what the intention is, and not just on the actual letter of the law?

I really hope so, because the intention of the risk based approach is to encourage sponsors to concentrate on what is important. Having said that, I totally agree with you that the pharmaceutical industry is very often doing their utmost to complicate things, and I worry that some sponsors are going to implement some very complicated risk-based quality management system that is taking away the whole idea of concentrating on the importance.

I've already heard rumors about companies setting up projects in which they are writing a vast number of SOPs in order to put this one regulation into place. That’s where the danger lies, because the whole intention is to simplify the process by doing only what is important.

If someone is going to register and join this webinar and they think that they're ready for E6(R2), what questions should they be asking themselves – or asking of their organization – to determine if they really are ready for these changes?

Well from the sponsor side, I would say that it's a question of oversight. Irrespective of whether you're a big pharmaceutical company or a small biotech company, how do you ensure that that you have oversight of all the different aspects of conducting a clinical trial?

In my opinion, the majority of these new guidelines are about oversight and control. You need to ask yourself how you can ensure that the system put in place can control what is important, without hindering your operation.

For more information on their upcoming webinar, I spoke to Andrew Mitchell, Director of Life Sciences at Intralinks.

For attendees that may have participated in your last webinar on the same topic, what can they expect will be different about this webinar?

The goal of this webinar is to answer real-world questions about the revised guideline. The previous webinar was focused on explaining what has changed with ICH-GCP E6(R2), and discussing its impact from the perspective of the investigator site.

When we followed up with attendees after that event, a lot came back and said that it was really helpful but they now have more questions, and could we organize a follow-up session.

As the implementation date for ICH-GCP E6(R2) approaches and sites are going to start being inspected, organizations want to make sure they’re fully prepared and not feel like they're at risk.

In that regard we are really fortunate to have Gunnar join Dan and myself to share his insight. He’s conducted countless GCP inspections around the world and was on the European agency working groups that determine how regulatory agencies should interpret and enforce regulations.

Do you have more questions about ICH-GCP E6(R2)? Submit your queries in advance of Intralinks’ upcoming webinar to get expert insight.

*Editor's Note: Date of implementation updated to reflect effective date in EU.

Keywords: GCP, CRO, FDA



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