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Suensonsgade Andriani granado Frederiksberg C 1909 90882024

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9088-2024 Rapporterede numre

Suensonsgade
Andriani
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Frederiksberg C 1909
90882024

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Frederiksberg C 1909



Første søgedato : 27/07/2018 01:51:42
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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
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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.

Operation PANGEA 2022: 500 packages seized in the customs and 35 websites reported to the police for illegal trading in pharmaceuticals
The last days of June saw the roll out of the 2022 version of the Interpol-managed Operation Pangea XV – a global initiative targeted illegal trade with medicines and medical devices. The Danish Medic

Land Vejledende Nummer
Frankrig 33 +330882024
Tyskland 49 +490882024
England 44 +440882024
Spanien 34 +340882024
Italien 39 +390882024
Schweiz 41 +410882024
Portugal 351 +3510882024
Holland 31 +310882024
Belgien 32 +320882024
Marokko 212 +2120882024
Tunesien 216 +2160882024
Algeriet 213 +2130882024
Irland 353 +3530882024
Elfenbenskysten 225 +2250882024
Mali 223 +2230882024
Danmark 45 +450882024
Rusland 7 +70882024
Kina 86 +860882024
Mexico 52 +520882024
Tjekkiet 420 004200882024
Moldova 373 003730882024
Malta 356 +3560882024
Luxembourg 352 +3520882024
Bosnien 387 +3870882024
Hviderusland 375 +3750882024
Norge 47 +470882024
Bulgarien 359 +3590882024
Ukraine 380 +3800882024
Slovakiet 421 +4210882024