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Update on Brexit: Impact on future and current clinical trials in Germany

As the withdrawal of the United Kingdom from the European Union is coming closer, the Competent Authority in Germany (BfArM) recently published their procedures for the period thereafter.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Jan 8, 2019 5:05:00 PM
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New timelines for the EU Portal and implementation of the EU Clinical Trial Regulation

The EU Clinical Trial Regulation No 536/2014 (CTR), which aims to harmonise the assessment and supervision for clinical trials throughout EU Member States, was originally planned to come into application this month (October 2018). As reported earlier, the implementation of the CTR depends on the availability of a functional EU Portal, the single entry point for submitting clinical trial information in the EU, and database.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Oct 17, 2018 5:12:00 PM
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CGM in pregnant women with type 1 diabetes

The CONCEPTT trial

Pregnant women with type 1 diabetes have an increased risk of preeclampsia, polyhydramnios and caesarean sections. Furthermore, for the infants of pregnant women with type 1 diabetes increased rates of congenital anomalies, premature deliveries, macrosomia, stillbirth and NICU admissions are reported. All these risks are known to increase with higher HbA1c values before or during pregnancy. Therefore the use of continuous monitoring in such patients might be advantageous, aiming for an optimal glucose control during pregnancy.  

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Topics: Clinical Trials in Diabetes, Treating Diabetes, Diabetes Technology

Posted by Dr. Grit Andersen on Jun 26, 2018 5:11:00 PM
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New tracking tool for EMA’s relocation to Amsterdam

Moving to Amsterdam

EMA is moving on in its relocation to Amsterdam; since the  5th of March a new tool gives transparent overview of main milestones and work stream deliverables.

Moving to Amsterdam is planned before 29th of March 2019; however the relocation has to be done in two steps: for 15th of November 2019 a completely new, tailor-made building has been outlined by the Dutch Authorities in the Zuidas business district. The interim period (April to mid November 2019) will be covered by temporary premises in the Sloterdijk area of Amsterdam.

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Topics: Clinical Trials in Diabetes, Clinical trials in Obesity

Posted by Dr. Grit Andersen on Mar 27, 2018 5:19:00 PM
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Implementation of EU directive 536/2014: Ethic committees prepare for the next level

Some decisive steps were taken in Germany towards the implementation of the above-mentioned regulation, especially with regard to the work of the Ethic Committees. The regulation about the evaluation of clinical trials [Verordnung über das Verfahren zur Zusammenarbeit der Bundesoberbehörden und der registrierten Ethik-Kommissionen bei der Bewertung von Anträgen auf Genehmigung von klinischen Prüfungen mit Humanarzneimitteln (Klinische Prüfung- Bewertungsverfahren-Verordnung – (KPBV)], published in July 2017, contains some very specific requirements for Ethic Committees participating within the “Directive working frame”.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Feb 7, 2018 4:40:00 PM
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Non-invasive liver fat and liver stiffness screening at Profil

Profil uses transient elastography with controlled attenuation parameter in order to pre-identify potential trial participants for the presence of liver fat and/or the presence of an intermediate state of liver fibrosis. Dependent on the outcome subsequently MR (magnetic resonance)-based methods and liver biopsy are available for further substantiating the findings. The great advantage of this non-invasive and quick approach is economising trial conduct by reducing the number of more elaborate examinations and controlling the sample size required for a meaningful trial design. This blog text describes the transient elastography method in the context of the increasing interest in treating subjects with NAFLD (non-alcoholic fatty liver disease).

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Topics: Clinical Trials in Diabetes, Clinical Trial Methods

Posted by Dr. Grit Andersen on Sep 28, 2017 5:22:00 PM
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Update to the EU Directive 536/2014 and Brexit

If you have been following our blog, you have been reading quite a lot about the European new clinical trial regulation adopted on 16 April 2014. We have already discussed the changes on clinical trials, the pilot project in Germany and the challenges Germany is facing due to the implementation of this project. 

Since EMA's management board had another meeting last June, we have new updates to share with you! During the last meeting decisions were made regarding the consequences of the Brexit for the EMA, the physical relocation of the Agency and new changes to the directive timeline.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Jul 21, 2017 4:30:00 PM
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First in Human (FIH) Trials: New draft guideline for Risk Mitigation

To provide best achievable clinical safety is always a challenge in first in human trials. Starting with the decision to proceed from preclinical research to the clinical development of a new drug researchers are confronted with many challenges including creating an appropriate study design, preparing the regulatory documents, conducting the clinical trial and, finally, drawing the right conclusions from the data.

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on May 16, 2017 3:40:00 PM
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The New Clinical Trials Regulation EU No 536/2014 - Amendments to the German Drug Law

 

Since the new clinical trial regulation has been adopted on 16 April 2014, Profil has been anticipating the changes to be compliant with the new regulation as soon as necessary.   Through our blog, we have been updating you about the changes on clinical trials, the pilot project in Germany- which allows sponsors to submit clinical trials according the new regulation before it will become applicable (October 2018) - and the challenges Germany is facing due to the implementation of this project.


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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on Mar 9, 2017 5:02:00 PM
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The New Clinical Trials Regulation EU No 536/2014 - Update (02/2017)

When we last posted about the new clinical trial regulations, we promised to give an update to make sure you stay informed about the ongoing change process and any updated timelines. So here it comes. Make sure to read and to sign up for our blog posts, so you won't miss future updates on this important change in regulation. 

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Topics: Clinical Trials in Diabetes

Posted by Dr. Grit Andersen on May 4, 2016 1:00:00 PM
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