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25569023 Talværdi
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Bryghusgade De Iríbar mamodaly Copenhagen K 1098 25569023 Unotel

25569023

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2556-9023 Unotel Rapporterede numre

Bryghusgade
De Iríbar
mamodaly
Copenhagen K 1098
25569023
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(2556)9023
2556-9023
25569023
004525569023
+4525569023
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5569023
25569023
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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 +335569023
Tyskland 49 +495569023
England 44 +445569023
Spanien 34 +345569023
Italien 39 +395569023
Schweiz 41 +415569023
Portugal 351 +3515569023
Holland 31 +315569023
Belgien 32 +325569023
Marokko 212 +2125569023
Tunesien 216 +2165569023
Algeriet 213 +2135569023
Irland 353 +3535569023
Elfenbenskysten 225 +2255569023
Mali 223 +2235569023
Danmark 45 +455569023
Rusland 7 +75569023
Kina 86 +865569023
Mexico 52 +525569023
Tjekkiet 420 004205569023
Moldova 373 003735569023
Malta 356 +3565569023
Luxembourg 352 +3525569023
Bosnien 387 +3875569023
Hviderusland 375 +3755569023
Norge 47 +475569023
Bulgarien 359 +3595569023
Ukraine 380 +3805569023
Slovakiet 421 +4215569023