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Requirements for Electronic Signature of Clinical Trial Applications Submitted In Fully Electronic Format

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 22 December 2020

Important Information for Applicants for Clinical Trials through the Voluntary Harmonisation Procedure - Brexit and Christmas Break 2020/2021

VHP procedures since 23rd October 2020

IMP with GMO for the treatment of COVID in CT 12.11.2020

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

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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

 
 

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