blog & news
Case Study: Controlled validation management of the myGCP application with ION Pharma
Originally posted on the ION Pharma website here. The goal: To empower myGCP, a regulatory intelligence learning...
GCP Central, e-learning provider for clinical research, joins Reducate EdTech Group
Utrecht, September 11th, 2024 – Reducate EdTech Group, a leading player in professional online continuing education, announced the acquisition of Amsterdam-based GCP Central today. Reducate serves more than 175,000 professionals in more than 40 different professions with eCPE.
GCP Central and NFU Launch Innovative eBROK® Course for Continuous Learning in Clinical Research
GCP Central is proud to announce the launch of the eBROK® course that was built for the Netherlands Federation of University Medical Centres (NFU).
Implementation of ICH GCP E6 (R3) Update: Key Points and Process Overview
The update to the ICH E6(R3) guideline is currently in its final stages. Step 3 and 4 are, as currently discussed in the ICH Assembly meeting in Japan, expected around October 2024. If that timeline indeed is met, the updated Good Clinical Practice Principles and Annex I will be adopted in October 2024. This allows for regional implementation to commence from that point, which could be within a timeframe of 1 month, depending on the region.
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.
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.
Interview with Prisca van Leeuwen: “Having your own little store in the store”
Prisca van Leeuwen is the one subjected to our Q&A this time. This good-humored pharmacy assistant from the Groene Hart Hospital has a passion for clinical trials.
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.
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.
FAQ: Transition to EU CTR – No need to panic!
We are getting more and more questions about the EU CTR. The transition period is about to end, and we ‘re noticing it. That’s why we would like to share with you the most critical issues:
NFU assigns development of future-proof eBROK® course to GCP Central
The Nederlandse federatie van umc’s (NFU) (English: Dutch Federation of University Medical Centers) has awarded GCP Central the contract to develop further and maintain the e BROK® course from 2024 to 2027.
Interview with Jacintha Ronden: “The best thing about doing research is still the collaboration.”
This time, we spoke to Jacintha Ronden of Cardialysis. We congratulated her on her promotion from project manager to department manager last week.
ICH-GCP R3: Why Innovative ICH-GCP Training Matters
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.
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.
Interview with Jiska Meijer “Looking in depth and daring to make mistakes”
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.
You win some, you lose some.
Last year we, Marieke Meulemans (CEO of GCP Central) and Valerie Prins (now copywriter of GCP Central), had a...
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.
Decentralized Clinical Trials – The Research of The Future
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?
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.
Interview With Manon Haanepen-Witkamp: “Nothing Is Standard Here And I Like That”
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.”
Meet The Team: Introducing Wan Yen, Business Developer
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.
Mygcp powerapp: acknowledge your knowledge part 3
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?
MyGCP Powerapp: Acknowledge Your Knowledge Part 2
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.
Interview with Anne van der Plas: “All the little steps are fascinating.”
“I liked how you set it up; you really get involved in thinking about the topic.”
MyGCP Powerapp: Acknowledge your knowledge
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
Medical Device Regulation: The Need for Clinical Expert Involvement
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).
EU CTR And CTIS: First Learnings From Working With CTIS And When Known Issues Will Be Solved.
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.
Implementing the EU CTR: Publishing Clinical Trial Reports and Transparency
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.
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.
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.
Why your team needs MDR training: From an Expert
The transition from the previous MDD to the new MDR brings a period of change. But what impact will this have on...
Are you EU CTR Ready? Our must-have Checklist for January 31, 2022.
Today's the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the...
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.
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.
ECTR And MDR: Marieke Meulemans Presenting At The SCRS European Site Solutions Virtual Summit
We’re proud to announce that Marieke Meulemans will present “ European Clinical Trial Regulation (ECTR) and...
Is Continuous Learning The Answer? Join Marieke Meulemans Live and Discover The Answer
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.
Expanding Our Course Catalog with a New German Refresher ICH GCP Course
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).
Introducing Our New Good Manufacturing Practice (GMP) Online Course
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.
Software Update 2.11: What’s New in myGCP?
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.
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 New ICH-GCP Course for Sponsors in International Clinical Trials
Announcing the latest addition to the GCP Central online course offerings: Expert ICH GCP Course for Sponsors in International Clinical Trials.
Your GCP Learning Preferences Discovered
As learning methods change and the pressure to manage time efficiently evolves, so does the need to provide effective,...
The Most Popular International myGCP Courses Of 2020
2020 has been an unprecedented year of change; companies, organizations, and individuals needed to evolve and adapt...
Simple Steps To Creating Your myGCP Account
Managing our time effectively at work is a constant challenge, made even more...
GCP Central Launches Online CFR training Course For Clinical Trials In The USA
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 …
Announcing the launch of our refreshed website
It's official, after months of hard work and dedication, it's time to launch our refreshed website. We wanted to make...
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.
Validation in 6 Steps: How to Validate Computerized Systems in Clinical Research
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…
