On 16 September 2014, a new revision of Module VI on Management and Reporting of Adverse Reactions to Medicinal Products came into effect. GVP Module VI has been revised to provide clarification on the clock start for reporting…
MHRA clarifies expedited reporting requirements for clinical trials
Published by MHRA on 09-Apr-2014 Individual case study reports (ICSRs) are being wrongly expedited to the MHRA as spontaneous cases. The guideline on good pharmacovigilance practices (GVP) Module VI – Management and reporting of adverse reactions to medicinal products; section…