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Kristianiagade Azenor fique Copenhagen K 1027 89826085 Waoo!

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Første søgedato : 25/07/2018 00:57:26
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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
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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.

Land Vejledende Nummer
Frankrig 33 +339826085
Tyskland 49 +499826085
England 44 +449826085
Spanien 34 +349826085
Italien 39 +399826085
Schweiz 41 +419826085
Portugal 351 +3519826085
Holland 31 +319826085
Belgien 32 +329826085
Marokko 212 +2129826085
Tunesien 216 +2169826085
Algeriet 213 +2139826085
Irland 353 +3539826085
Elfenbenskysten 225 +2259826085
Mali 223 +2239826085
Danmark 45 +459826085
Rusland 7 +79826085
Kina 86 +869826085
Mexico 52 +529826085
Tjekkiet 420 004209826085
Moldova 373 003739826085
Malta 356 +3569826085
Luxembourg 352 +3529826085
Bosnien 387 +3879826085
Hviderusland 375 +3759826085
Norge 47 +479826085
Bulgarien 359 +3599826085
Ukraine 380 +3809826085
Slovakiet 421 +4219826085