in adolescents, which should be reflected in the protocol. the need for informing participants to seek advice about donation and cryopreservation of germ cells in line with this guidance prior treatment if applicable, has been added to the section on the need for sexual counseling of study subjects, e.g.after the relevant systemic exposure to the medicinal product has ended for exposure to other types of genotoxicants than aneugenic compounds, the duration for applying highly effective contraception measures for women of childbearing potential, has been extended from 1 month to 6 months (one folliculogenesis cycle).Update to document has been adopted and implemented on Recommendations related to contraception and pregnancy testing in clinical trials, version 1.1 | pdf.Best Practice Guide for sponsors of transition multinational clinical trials | pdf.Recommendation Paper on the Initiation and Conduct of Complex Clinical Trials | pdf.Link to National guidance on CT management during the COVID-19 pandemia | pdf.Update of the guidance 28 April 2020 available here Guidance to sponsors on how to manage clinical trials during the COVID-19 pandemic | pdf.Guidance document for sponsors for a Voluntary Harmonised Procedure for the assessment of multinational Clinical Trial Applications, Version 5, October 2020 | pdf.European Union Member States participation in VHP and VHP-related activities, October 2020 | pdf.European Union Member States national pilot projects in support of the transition to the new Clinical Trial Regulation EU 536/2014, October 2020 | pdf.VHP procedures in preparation and in case of a no-deal Brexit | pdf.Results of the Voluntary Harmonisation Procedure 2009 - 2020, February 2021 | pdf.VHP - Brexit and Christmas Break, October 2020 | pdf.Conclusion of the Voluntary Harmonization Procedure project, July 2021 | pdf.Technical notice to sponsors regarding continuous compliance with the EU legislation for clinical trials following the withdrawal of the United Kingdom from the EU | pdf UK/ EU transition period will end on December 31 2020. Periodic Safety Update Reporting (PSUR) - Synchronisation and Work-sharing.Task Force (veterinary) on Antimicrobial Issues.Pharmacovigilance Working Party - veterinary.Homeopathic Medicinal Products Working Group.
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