The Focus of PharmacoVigilance as an integrated risk-benefit evaluation
Online Training Id: GVP-001
Geographical Region: International
This course gives an overview about the legal background of Pharmacovigilance regulation, and will review the new regulations for Good Vigilance Practice, the PharmacoVigilance System, Master file, and the duties & responsibilities of the Qualified person (PhV).
The presenter will review the NEW regulations relevant to Pharmacovigilance systems in Europe and the actions necessary to prepare the Pharmacovigilance System Master File (PSMF).
Dr Borislav Borissov MD, is the former Executive Director (1998 to 2004) of the Bulgarian Health Authority and was responsible for all interactions with the EU Commission, EMEA, CADREAC, WHO and EU competent authorities. He is an expert dealing with the highly prescriptive requirements of the EU Regulatory Authorities and the FDA for Pharmacovigilance. He is a registered SME in Europe and EudraVigilance user with who is a Qualified Person for Pharmacovigilance for XEVMPD and E2B reporting.
He has extensive experience developing and executing clinical trial protocols, medical writing, consultation, and project management. He has conducted or been involved in many scientific assessments with the competent authorities (CAs) in Europe. An expert in the development of the eCTD for submission in EU and Middle East; he has a conducted many Regulatory, Good Clinical Practice and Pharmacovigilance training programs in throughout Europe including Serbia, Bosnia as the UK, Greece, Switzerland, and in the in Middle East. He is fluent in English, French, and Russian.
Dr. Boris Borissov MD
CLINICAL RESEARCH –PHARMACOVIGILANCE