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Asylgade Thimothée madeleine Copenhagen V 1764 42806258 Unotel

42806258

brugere rapporterede dette som svindel 004542806258

202.107.91.47
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90.85.24.204
170.162.86.86
15.10.13.32

4280-6258 Unotel Rapporterede numre

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Thimothée
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Copenhagen V 1764
42806258
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42-80-62-58
42 80 62 58
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2806258
42806258
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Copenhagen V 1764



Første søgedato : 08/09/2018 00:10:26
Sidste søgedato : 27/11/2022 14:54:35

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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.

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

New Data Ethics Charter provides a framework for the Danish Medicines Agency’s use of health data
The Danish Medicines Agency has adopted a Data Ethics Charter consisting of seven principles of data ethics. The charter is to set high ethical standards for the protection and handling of the health data included in the scientific and statistical analytical work performed by the agency.

The Danish Medicines Agency will be closed on Friday 10 June 2022
The Danish Medicines Agency will be holding its staff convention and will be closed on  Friday 10 June 2022 However, we process urgent applications for compassionate use permits (applications for d

New executive order raises fees in the area of the Danish Medicines Agency
Higher fees become payable for medicinal products and pharmaceutical companies as a result of a new executive order entering into force on 1 May 2022. The last time the fees were adjusted was in 2017.

Management of clinical trials in light of the current situation in Ukraine
The current situation in Ukraine can have an impact on the conduct of clinical trials. It can affect both the supply of trial-related drug products and the collection of critical data. Therefore, an initial guidance on the management of clinical trials in light of the situation have been issued by the European Commission (EC), the European Medicines Agency (EMA) and the Clinical Trials Facilitation and Coordination Group (CTCG).

Land Vejledende Nummer
Frankrig 33 +332806258
Tyskland 49 +492806258
England 44 +442806258
Spanien 34 +342806258
Italien 39 +392806258
Schweiz 41 +412806258
Portugal 351 +3512806258
Holland 31 +312806258
Belgien 32 +322806258
Marokko 212 +2122806258
Tunesien 216 +2162806258
Algeriet 213 +2132806258
Irland 353 +3532806258
Elfenbenskysten 225 +2252806258
Mali 223 +2232806258
Danmark 45 +452806258
Rusland 7 +72806258
Kina 86 +862806258
Mexico 52 +522806258
Tjekkiet 420 004202806258
Moldova 373 003732806258
Malta 356 +3562806258
Luxembourg 352 +3522806258
Bosnien 387 +3872806258
Hviderusland 375 +3752806258
Norge 47 +472806258
Bulgarien 359 +3592806258
Ukraine 380 +3802806258
Slovakiet 421 +4212806258