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Westend Piredda le rouzo Aalborg Øst 9220 37034344 Minitel

37034344

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004537034344
+4537034344
tel:+4537034344
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7034344
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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
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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 +337034344
Tyskland 49 +497034344
England 44 +447034344
Spanien 34 +347034344
Italien 39 +397034344
Schweiz 41 +417034344
Portugal 351 +3517034344
Holland 31 +317034344
Belgien 32 +327034344
Marokko 212 +2127034344
Tunesien 216 +2167034344
Algeriet 213 +2137034344
Irland 353 +3537034344
Elfenbenskysten 225 +2257034344
Mali 223 +2237034344
Danmark 45 +457034344
Rusland 7 +77034344
Kina 86 +867034344
Mexico 52 +527034344
Tjekkiet 420 004207034344
Moldova 373 003737034344
Malta 356 +3567034344
Luxembourg 352 +3527034344
Bosnien 387 +3877034344
Hviderusland 375 +3757034344
Norge 47 +477034344
Bulgarien 359 +3597034344
Ukraine 380 +3807034344
Slovakiet 421 +4217034344