adminMTE_04792023-03-31T09:04:26+00:00May 6th, 2021|Categories: Europe, MDR, Regulatory|Tags: Clinical Trial, Europe, Germany, MDR, Regulatory|
The medical device regulation EU 2017/745 allows Member States some adjustments for local implementation. If you sponsor a trial in Germany, you must learn what are the new ordinances and guidelines for the implementation of the MDR. [...]
k.janecek2024-02-29T13:51:45+00:00June 2nd, 2020|Categories: Europe, Regulatory, Western Europe|Tags: Clinical Trial, Germany, Regulatory|
*** Deutsche Sprache unten *** MPG Basic Course for Investigators, Deputies and Members of the Clinical Study Group - NEW at the Meditrial Academy Berlin The MPG basic course based on the recommendations of the German Federal Medical Association [...]
k.janecek2024-02-26T11:08:52+00:00May 22nd, 2020|Categories: Clinical Trial, Covid-19, Europe, Regulatory|Tags: BfArM, Clinical Trial, Covid-19, Germany, Regulatory, Western Europe|
BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte) and PEI (Paul-Ehrlich-Institut) provided supplementary recommendations to the guideline on management of clinical trials during COVID-19 released by the European authorities on 20th March 2020. Key points of BfArM and PEI recommendations on [...]
adminMTE_04792024-02-26T11:15:21+00:00May 20th, 2020|Categories: Europe, Regulatory, Western Europe|Tags: BfArM, Clinical Trial, DIMDI, Europe, Germany, Regulatory, Western Europe|
DIMDI (Deutsche Institut für Medizinische Dokumentation und Information) and BfArM (Federal Institute for Drugs and Medical Devices) will join to become one agency on May 26th, 2020. Once DIMDI is merged into BfArM, the name that has been in [...]
adminMTE_04792024-02-26T11:10:55+00:00March 18th, 2020|Categories: Europe, Western Europe|Tags: Clinical Trial, Covid-19, Europe, Germany, Helpline, Western Europe|
Germany reacts to the pandemic with high attention to ongoing clinical trials. According to the government authority BfArM, protocol deviations and changes may occur with the dynamic risk situation and restrictions due to Coronavirus SARS-CoV-2. A dedicated email, CT-COVID@bfarm.de, [...]
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