New Belgian law related to clinical research just published

22nd May 2017

 

Dear BeCRO Members,

 

Yesterday, the new law has finally been officially published.

This law will prepare our country for the implementation of the Clinical Trial Regulation

DOWNLOAD HERE :

22052017-MB-BS-essaiclinique-klinischeproeven-Small.pdf

Patient information on biosimilars

Clinical research news

We are pleased to inform you that the European Commission has published 6 new language versions of the patient information document "What you need to know about biosimilar medicines", so that patients now have access to unbiased and reliable information in English, French, German, Italian, Polish, Portuguese and Spanish. The information document can be downloaded and printed here: Commission publishes Q&A on biosimilar medicines for patients.

 

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Impact of BREXIT on EMA

Clinical research news

Read here the latest article on impact of Brexit on EMA, from APPLIED CLINICAL TRIALS DIRECT:

EMA Admits Brexit May Cause Significant Disruption

Dec 20, 2016

By Philip Ward

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Draft Guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products

December 2, 2016

Clinical research news

The EMA has issued a draft guideline on strategies to identify and mitigate risks for first-in-human and early clinical trials with investigational medicinal products.

 

 

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Change to Annex VI

August 25, 2016

Clinical research news

Dear BeCRO Members,

You will be aware of the concerns with the CTR Annex VI and its potential impact on

industry and patients.  EFPIA is the leading party advocating this concern.

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