blog & news

CONTINUOUS LEARNING: ONE OF OUR BUILDING BLOCKS

CONTINUOUS LEARNING: ONE OF OUR BUILDING BLOCKS

Continuous learning is not just a trendy term. It stands for continuing education, which, compared to older learning methods, is a much more efficient way to keep knowledge and qualifications up to date. You also stay abreast of new developments more easily. We embrace this way of learning and are increasingly implementing it in our training courses.

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Navigating the European Medical Device Regulation Changes: A Guide for Clinical Research Professionals

Navigating the European Medical Device Regulation Changes: A Guide for Clinical Research Professionals

In clinical research, staying up to date with regulatory changes is paramount to ensuring the safety and efficacy of medical devices. With the implementation of the European Medical Device Regulation (MDR), effective from May 26, 2021, significant shifts have occurred in the landscape of medical device trials. These changes dictate the timelines and protocols for new trials and necessitate adjustments to existing ones.

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MDR VS MDD: WHAT YOU NEED TO KNOW

MDR VS MDD: WHAT YOU NEED TO KNOW

The Medical Device Directive (MDD) has governed medical device regulation within the European Union since its inception in 1993. However, the evolution of technology and the healthcare landscape has rendered the MDD outdated. Consequently, a pressing necessity arises for a more comprehensive regulatory framework attuned to contemporary technological advancements.

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FAQ: HOW CAN I open My Certificate?

FAQ: HOW CAN I open My Certificate?

This month’s frequently asked question: Why can’t I open my certificate?  With the upcoming ICH GCP R3 update, and the need for innovative and up-to-date training, it’s also essential to have access to your certificates, and know how long they’re valid for.  

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ICH GCP R3 – What should we expect? Part 2 

ICH GCP R3 – What should we expect? Part 2 

Since ICH-GCP (or officially, ICH E6 R1) was first drafted more than 20 years ago, the complexity of clinical trials has increased, with the design of trials, technology use, and data quality and collection changing to the evolving face of research.  

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ICH-GCP R3: What should we expect? Part 1 

ICH-GCP R3: What should we expect? Part 1 

The first update to ICH-GCP (r2) was published in 2016 and focused on a risk-based approach to clinical trials and their design and conduct. However, since the publication of this update, clinical trials have continued to evolve with new designs and technological innovations. The upcoming update of ICH GCP (Good Clinical Practice), the E6(R3), will be designed to advance the concept of risk-based approach further and encourage relevant parties to utilize it. 

In Part 1 of this series, we will talk about the overall changes expected in ICH-GCP R3, and in Part 2, we will explore the changes to the annexes.

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HOW LONG IS MY GCP CERTIFICATE VALID?

HOW LONG IS MY GCP CERTIFICATE VALID?

How long is my GCP certificate valid? This is one of our frequently asked questions. While some companies offer certificates for 2, 3or 4 years, at GCP Central we take our training a little more indepth.  In this article, we’ll go over some key factors about our GCP training, and explore the depths of how long our training lasts.

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Implementing CTIS: What you Should Know

Implementing CTIS: What you Should Know

This is the first in a series of articles where GCP Central goes in-depth into the challenges, learnings, and critical findings of implementing the new European Clinical Trials Regulation (EU CTR). In this instalment, we reflect on the Clinical Trials Information System (CTIS), the unique single-entry point and database for clinical trials, and the issues surrounding the slower system adoption.

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Checking In – Are You Inspection Ready with MDR and EUCTR?

Checking In – Are You Inspection Ready with MDR and EUCTR?

In the past few months, 2 new regulations have been put into place in the world of clinical trials. The EU Clinical Trials Regulation and the Medical Devices Regulation (MDR) (EU 2017/745) have been implemented. This has created a new need for training teams to streamline trials, and be compliant.  

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January 31, 2022: EU CTR goes Live.  Are you ready?

January 31, 2022: EU CTR goes Live. Are you ready?

On the 31st of January, 2022, the European Commission’s new clinical trial legislation will come into effect. With the hope of creating a better environment to conduct clinical trials within the EU, the European Clinical Trials Regulation (EU CTR 536/2014) creates a uniform standard that all future trials will need to adhere to when conducting trials for medicinal products for human use.  

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Which course is right for me? Plans unveiled for course title updates

Which course is right for me? Plans unveiled for course title updates

Did you know that over the past year, we have increased the number of courses we offer by 400%? As our company has grown, so has our GCP training course portfolio, providing a more extensive range of courses catering to both the Dutch and English-speaking research communities Our commitment is to provide a better way of training, and we are changing our course titles to help you more easily find the course you need.

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