Bulgaria changes the structure of its ethics committees in clinical trials
The Bulgarian Drug Law amendments published on 12-Oct-2018 introduced the biggest changes in the field of clinical trials in many years. Apart from sy...
With the implementation of the new pharmacovigilance legislation we have trained our experts to maintain compliance with the current drug safety/pharmacovigilance obligations:
– Appointment of local contact person for pharmacovigilance matters and deputy officer (24/7 service);
– Weekly literature screening and translation services;
– Communication point between the local authorities, local healthcare professionals, patients, client’s sales force and client’s QPPV;
– Follow up of Individual Case Safety Reports;
– Pharmacovigilance Trainings of client’s sales force;
– Implementation of local SOPs.
The Bulgarian Drug Law amendments published on 12-Oct-2018 introduced the biggest changes in the field of clinical trials in many years. Apart from sy...
The Announcement of the EMA Management Board earlier in May 2017 confirmed the full functionality of the EudraVigilance database. Hence, the transitio...
Starting from 13 June 2016 onwards the transitional rules for submission of PSURs to the National Competent Authorities are no longer applicable. MAHs...
Based on the application of Article 57(2) of Regulation (EC) No 726/2004, as of 1 February 2016 the marketing authorisation holders of medicinal produ...