Complying with GCP – “The 12 rules” and a bit more
Online Training Id: GCP-002
Geographical Region: International
Level: Basic
Duration: 1 hr 30 mins
A practical course, designed to sponsors and investigators as well as their third parties and research staff members. Includes the most common rules to avoid non-compliance, known as “The 12 rules”.
Learning Objectives:
To become familiar with the investigator and sponsor’s responsibilities, as well as to learn The 12 rules how to ensure ICH GCP compliance.
Who Should Enroll :
Investigators and members of the research staff, sponsors and their representatives and partners /CROs, SMOs, Project coordinators, Data managers and others
Author:
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
