blog & news
This time, we spoke to Jacintha Ronden of Cardialysis. We congratulated her on her promotion from project manager to department manager last week.
why do we also emphasize things like quality training and the validity of GCP certificates? Here’s an overview of why innovative ICH-GCP training matters.
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.
The third person to speak in this series is Jiska Meijer, a general practitioner with a PhD, co-founder of GPRI and deputy head of general practitioner training at the UMCG since the beginning of this year.
Last year we, Marieke Meulemans (CEO of GCP Central) and Valerie Prins (now copywriter of GCP Central), had a...
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.
More and more studies are being conducted involving staff who don’t handle all aspects of GCP, especially in Decentralized Clinical Trials. There is a lot of uncertainty about what these people need to know about Good Clinical Practice.
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.
And that is precisely Manon’s strength. She derives great pleasure from the fact that there is “There is always something new, there is always something to figure out. Nothing is standard here and I like that then.”
With extensive experience in pharmaceuticals and Good Clinical Practice, Wan Yen joined our team recently as a Business Developer. This blog will take a few moments to learn more about her, her experience, and what she hopes to bring to GCP Central.
We will soon be launching our new myGCP Powerapp. We are incredibly excited about it and will give you an insight into its development in this blog. Why this app?
The Medical Device Regulation: Why a Delay in Implementation, and What is The Impact on Your Clinical Trials?
With the European Commission recently adopting a proposal to give a longer transition time to adapt to the Medical Device Regulation (MDR), important questions to pose are why this delay and how does it impact your clinical research-related work?
This 3-part series will take you through the app’s whys and hows and the pilot experiences. You could read in the previous part about our motivation to develop the powerapp. Now we take a closer look at how the app works.
“I liked how you set it up; you really get involved in thinking about the topic.”
We’re close to launching our new myGCP Powerapp and are incredibly excited about it. We’d love to give you some insight into the app’s development in this blog
In this guest blog from Esther Daemen, we look at the need for the involvement of clinical experts in developing new medical devices, from concept to completion, and the importance of adhering to the new Medical Device Regulation (MDR).
This is the third and final part of 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 look at issues encountered in this first year of working with CTIS and essential information about how to cope with these.
It is essential that the results of clinical trials are publicly available. To ensure clinical trials (and their sponsors) are trusted, but most of all, to prevent participants from unnecessary studies. Let us find out where data from clinical trials within the EU can be accessed.
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.
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.
The transition from the previous MDD to the new MDR brings a period of change. But what impact will this have on...
Today's the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the...
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.
EU CTR and VGO: what impact do they have on research in the Netherlands? Reflections from the field: Thera Max-Mos, Sanofi
We spoke with Sanofi’s Thera Max-Mos, Head Clinical Study Unit ai, NL, to discuss these changes. We look at the impact this has had on the study and any teething problems in the procedure. She also shares her thoughts on the upcoming EU CTR introduction.
We’re proud to announce that Marieke Meulemans will present “ European Clinical Trial Regulation (ECTR) and...
Continuous learning Is a revolutionary concept, but when It comes to the world of GCP training, It has the potential to change everything. Rather than marking a checkbox every year, those Involved In clinical research could use bite-sized learning moments and optimize their learning.
Is Continuous Learning The Answer To A GMP and GLP Compliant Workforce? Live Webinar With Marieke Meulemans
Utilizing different approaches to GMP and GLP training can improve learning retention, reduce the time and money spent on retraining, and improve your team’s results. Your company can respond faster and be more flexible when it comes to changes in the industry.
Our Refresher ICH GCP Course is designed for study nurses and members of an investigational team who need to refresh their knowledge of the German Medicines Act (AMG) applicable to clinical drug research with human subjects (Arzneimittelstudien).
Our new Good Manufacturing Practice (GMP) online course covers the legal requirements and best practices for quality oversight on external manufacturing. Learn more about it here.
In our ongoing commitment to high-quality GCP training, as well as providing you with the latest updates available, myGCP will undergo a software update
Join our Live webinar: CFR (Code of Federal Regulations) and what it means for you. We’ll be live on Thursday, January 28th, at 4:00 PM CET.
Announcing the latest addition to the GCP Central online course offerings: Expert ICH GCP Course for Sponsors in International Clinical Trials.
As learning methods change and the pressure to manage time efficiently evolves, so does the need to provide effective,...
2020 has been an unprecedented year of change; companies, organizations, and individuals needed to evolve and adapt...
Managing our time effectively at work is a constant challenge, made even more...
Introducing the newest online course from GCP Central – Basic CFR Course for Clinical Trials In The USA. Learn about the principles of the Code of Federal Regulations that are required for the conduct of clinical trials in the USA …
It's official, after months of hard work and dedication, it's time to launch our refreshed website. We wanted to make...
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.
The Validation of software tools used in the conduct of clinical trials is listed as a requirement described in ICH-GCP guidelines. Learn more about the six steps of the Validation process here…
How can validation of your own or your vendor’s system help to ensure good quality clinical trials? Download GCP Central’s latest whitepaper here.
In the current COVID-19 crisis, where research has taken a central focus, and a lot of other studies have been halted. Discover why online learning is now more crucial than ever.
In the current crisis, hospitals are overburdened, and people have to stay at home as much as possible. How are we dealing with study visits and other aspects of the trials? Introducing the latest in the GCP Central webinars: Clinical trials during Corona: A risk-based approach in the interest of patients and data.
At GCP Central, our commitment is to providing quality training to our users. We appreciate feedback, and use this to improve our learning system, myGCP. After all, one of the most effective ways to learn is to be continuously updated with new knowledge and improve your skills based on this.
On the 10th and 11th of February, GCP Central (alongside Seuss+) attended the European Conference on Clinical Research...
This is a commonly asked question from medical and research professionals and in some cases a slight grey area. There...
GCP Central’s eBook: “An Introduction to Continuous Learning” uncovers insights and benefits of continuous learning and how it improves clinical trials.
We're pleased to announce that we're going live with our first webinar - How you can drive better quality clinical...
Are you ready for the European Clinical Trial Regulation (ECTR)? GCP Central launches 5 different ECTR training courses within myGCP
The 2020 implementation of the European Clinical Trials Regulation (ECTR) will bring big changes to the way that...
Another installment from our popular “Meet the Team” feature, this week we’re catching up with Saskia, who joined GCP Central earlier this year as Content & training manager. Join us as we find out all about Saskia’s role at GCP Central.