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65581363: Identificer ejeren af ​​65581363

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Stockholmsgade Sabine veliot Copenhagen K 1276 65581363 Fullrate

65581363

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202.106.94.50
100.7.2.28
90.84.24.204
170.167.81.81
15.9.12.33

6558-1363 Fullrate Rapporterede numre

Stockholmsgade
Sabine
veliot
Copenhagen K 1276
65581363
Fullrate

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5581363
65581363
Fullrate
Copenhagen K 1276



Første søgedato : 19/03/2018 01:28:11
Sidste søgedato : 27/11/2022 16:21:11

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Change of practice for the Danish Medicines Agency’s inspections
The Danish Medicines Agency is now implementing the digital signing system called Penneo. As of 1 November 2022, we will be using digital signatures to sign all inspection reports.

2022 deadline for submitting applications concerning marketing authorisations and clinical trials
The deadline for submitting applications concerning marketing authorisations and clinical trials is December 20th 2022. The Danish Medicines Agency is closed for the Holiday Season, from December 24th, 2022, until January 1st, 2023, both days included. Applications concerning marketing authorisations and clinical trials need to be submitted before December 20th, 2022. We will consider applications submitted after December 20th, 2022, as if they have been received January 2nd 2023.

Current Danish QRD template to be used in connection with the granting of marketing authorisations
Going forward, the current Danish QRD template is to be used for submissions of translations for new marketing authorisations under the mutual recognition procedure or the decentralised procedure as w

Invitation to EMA Organisation Management Service (OMS) Trouble Shooting Sessions for CTIS users
Before applying for clinical trials with investigational medicin products under the EU Clinical Trials Regulation no. 536/2014 (EU CTR), sponsors and trial sites have to be registered in EMAs Organizational Management Service (OMS). EMA is now inviting all sponsors and trial sites to online trouble shooting sessions, where they can submit questions in advance (see tabel below) concerning organisation and site registration in OMS.

Expression of interest for onsite participation in ACT EU workshop on Decentralised Clinical Trial guidance on October 4th 2022 – Response deadline is September 06th 2022.
New and innovative clinical trial designs and methodologiesprovide opportunities and challenges for the EU clinical trials environment. The EU decentralised clinical trials (EU DCT) project aims to address some of these challenges, in line with the European Medicines Agencies Network Strategy to 2025 and European Commission’s Pharmaceutical Strategy for Europe. Since March 2022, the Clinical Trials Coordination Group (CTCG) under the Heads of Medicines Agencies (HMA) have been responsible for the project management of the EU Decentralised Clinical Trials (EU DCT) project, with Ditte Zerlang Christensen of the Danish Medicines Agency (DKMA) as the project manager. The ACT EU Programme will host a multi-stakeholder workshop on DCTs on behalf of the EU DCT project, bringing together participants from all areas of the research community to share perspectives on this type of clinical trials. The multi-stakeholder workshop will be an onsite meeting hosted by EMA on October 4th 2022. A live broadcast of the workshop’s plenary session will be provided, open to all interested parties.

Land Vejledende Nummer
Frankrig 33 +335581363
Tyskland 49 +495581363
England 44 +445581363
Spanien 34 +345581363
Italien 39 +395581363
Schweiz 41 +415581363
Portugal 351 +3515581363
Holland 31 +315581363
Belgien 32 +325581363
Marokko 212 +2125581363
Tunesien 216 +2165581363
Algeriet 213 +2135581363
Irland 353 +3535581363
Elfenbenskysten 225 +2255581363
Mali 223 +2235581363
Danmark 45 +455581363
Rusland 7 +75581363
Kina 86 +865581363
Mexico 52 +525581363
Tjekkiet 420 004205581363
Moldova 373 003735581363
Malta 356 +3565581363
Luxembourg 352 +3525581363
Bosnien 387 +3875581363
Hviderusland 375 +3755581363
Norge 47 +475581363
Bulgarien 359 +3595581363
Ukraine 380 +3805581363
Slovakiet 421 +4215581363