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Information on documentation to be submitted for clinical trials on medicinal products for the treatment of COVID-19

Questions and Answers on the Use of Advanced Therapy Medicinal Products with Out-of-Specification Release Test Results

Opinion of SÚKL's Department of Clinical Trials on Medicinal Products on Ongoing Clinical Trials and To-Be-Commenced Clinical Trials in Light of the COVID-19 Epidemiological Situation of 25 June 2020, last updated 28 August 2020

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Brexit – on 7 May 2020, the European Commission published an updated notice to stakeholders

Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic vydané EMA a GCP IWG, verze 3. ze dne 28.4.2020

VHP - Voluntary Harmonization Procedures – re-engaging in VHP

Q&A from workshop 11.11.2019

Amendment to the Reimbursement Decree effective as of 1 June 2019

Safety Features on the Packaging of Authorised Medicinal Products vs. Clinical Trials on Pharmaceuticals

Voluntary Harmonization Procedure (VHP)

Whole section

BREXIT – Important Notice to Sponsors of Clinical Trials on Pharmaceuticals

Genetically Modified Organism (GMO) aspects for investigational medicinal products

Information for sponsors of clinical trials/submitters of Development Safety Update Reports (DSURs)

Amendments to protocol and updates to clinical trial dossier following the issuance of authorisation/approval of the conduct of the clinical trial

 
 

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