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...
We provide solutions for your pharmacovigilance system at national level in Bulgaria and Romania.
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.