Industry Insights

Inspection readiness is an ongoing task, as it involves not only mock inspection preparation but also efforts to ensure a consistent culture of readiness. Whether your inspection is around the corner or further in the future, attend this mock inspection workshop day for confidence in:

• How to effectively prepare for a mock inspection, including back office organisation
• Mock-interviews and how you can train potential interviewees
• How to turn a tricky inspection around by exploring how you can adapt during your inspection
• Successfully implanting follow-up activities
• The differences between a mock inspection and a real inspection

If you would like more information on the event including the 2 main conference days, click here for full details.

Inspections can occur at any time; therefore the preparation can be daunting. With acute consequences, it is crucial that best practices are in place to ensure that your recorded data and documentation is compliant when the inevitable inspection comes around. This interactive, expert-led training course will give you the opportunity to put your current strategies to the test, and bring you up to speed on the most pressing data integrity challenges, practices and expectations.

In order to prepare, pharmaceutical companies must understand the requirements and expectations of inspectors and how these can be satisfied. Pharma IQ asked Edyta Zbirog-Lukawska, Central Europe Quality and Compliance Adviser (Affiliate Process and Training Adviser), Roche, her top 5 tips to becoming GCP inspection ready.

We need to embrace the ‘Quality by Design’ mindset and embed quality in each and every task from the beginning”, says Edyta when telling Pharma IQ of her first tip. “By thinking about quality from the beginning, we can ensure inspection readiness at every stage of the study, and not be stressed out when the inspection is announced!”

Choosing the right Quality Management System plays an integral role in the inspection readiness journey and making sure that your company is following Good Clinical Practice. As one of the respondents mentioned:

"it minimises human error and improves transparency"

This infographic explores what companies want when it comes to choosing a QMS. We asked the industry experts if they could design their perfect QMS, what features they would like and what factors they look for when selecting a QMS. 

Download the infographic to find out more >>

Find out more in the full event blog here, or the event programme here.

With recent changes amongst GCP Guidelines, including the amendment of ICH E6 it is now more critical than ever to keep up to date and ensure a consistent culture of inspection readiness.

Ahead of GCP inspection Readiness Summit 2019, we have created a checklist to help you on your journey to be compliant and maintain a culture of quality. 

Download this handy checklist for a clear and concise guide to prepare for your next inspection >>

In the constantly evolving pharmaceutical regulatory environment, ongoing GCP inspection readiness is vital to ensure the successful launch of products.

We wanted to understand where the industry is positioned in regard to inspection preparedness and the key pain points which are preventing the maintenance of a readiness culture within both Sponsors and CROs.

We surveyed a number of clinical trial professionals about their organisation's readiness for inspections and have put them into this handy market report.

When a culture of readiness is embedded within an organisation, the greatest level of inspection readiness can be maintained.We wanted to gain a greater understanding of the most important elements to consider when creating a culture of readiness including the training, documentation maintenance and vendor management during the clinical trial. 

In this exclusive interview with Nancy Meyerson-Hess, Chief Compliance and Regulatory Officer, eMQT and Former Head of Clinical Operations and Compliance, Grünenthal we discuss the challenges and solutions of creating and maintaining a a culture of Clinical Trial Inspection Readiness. 

Ahead of GCP Inspection Readiness 2018 we have compiled a sample of this year's attendees. Take a look at who you can expect to meet, hear insights from and network with across the three-day event on the 20-22 November in Brussels, Belgium.

If you would like more information about the event including our full list of speakers, sessions and opportunities then please download the agenda here.

If you were handed with a notice for a clinical trial inspection plan right now, how would you react? - With a feeling of asserted confidence or a rush of slight concern? Wherever you think you would stand on this spectrum, use this infographic to learn from your peers’ mistakes. Pharma IQ invites the expertise of Andy Fisher Senior GCP Inspector MHRA on a list of common TMF failings.

Alongside a number of other EU member states, Andy was recently involved in drafting guidance that the EMA is due to publish shortly. This draft guidance for TMF will replace what is currently in volume 10.