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

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

by GCP Central | Jul 15, 2022 | GCP Central News, updates law & regulations

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...
Why your team needs MDR training: From an Expert

Why your team needs MDR training: From an Expert

by GCP Central | Mar 30, 2022 | GCP Central Products

The transition from the previous MDD to the new MDR brings a period of change. But what impact will this have on research and more importantly, what are the issues faced with non-compliance? With over 20 years of industry experience in biotech, pharma, and medical...
Are you EU CTR Ready? Our must-have Checklist for January 31, 2022.

Are you EU CTR Ready? Our must-have Checklist for January 31, 2022.

by GCP Central | Jan 31, 2022 | GCP Central News

Today’s the day the EU CTR comes into effect. This new legislation will majorly impact organizations involved in the design and implementation of clinical trials. Our previous blog covered the fundamentals of this new regulation and what made it different from...
January 31, 2022: EU CTR goes Live.  Are you ready?

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

by GCP Central | Jan 26, 2022 | GCP Central Products

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...
EU CTR and VGO: what impact do they have on research in the Netherlands? Reflections from the field: Thera Max-Mos, Sanofi

EU CTR and VGO: what impact do they have on research in the Netherlands? Reflections from the field: Thera Max-Mos, Sanofi

by GCP Central | Dec 13, 2021 | GCP Central News

On November 1, 2021, the new Local Feasibility Procedure and the use of the Research Institute Suitability Statement (VGO) will be in place. This is mandatory for drug research.  We spoke with Sanofi’s Thera Max-Mos, Head Clinical Study Unit ai, NL, to...
ECTR And MDR: Marieke Meulemans Presenting At The SCRS European Site Solutions Virtual Summit

ECTR And MDR: Marieke Meulemans Presenting At The SCRS European Site Solutions Virtual Summit

by GCP Central | Apr 20, 2021 | GCP Central News

We’re proud to announce that Marieke Meulemans will present  “ European Clinical Trial Regulation (ECTR) and Medical Device Regulation (MDR)” on April 21st, 2021, with co-panelists  Rianne Tooten and Isabelle van der Haegen. This session will be held between...
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