GCP Training for Clinical Investigation Teams
Online Training Id: GCP-001
Duration: 3 hrs
This Development program provides the essential Certification in GCP competence for Clinical Investigation teams required by Sponsors organisations before starting Clinical Trails. The program consists of a eLearning lecture which is supported by tutorial webinars based on This ICH E6 GCP Investigator Site Training meets the Minimum Criteria for ICH GCP Investigator Site Personnel Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
The Foundation course is provided in 4 modules;
Good Clinical Practice Overview
The Principals of ICH GCP
Responsibilities of the Investigator Teams
Responsibilities of the Sponsor
Participants in this course will be able to demonstrate an understanding of the background and practical implications of GCP which will require each delegate to undertake an assessment following which a certificate of competency will be awarded thus bridging the gap between theory and practice in their places of work;
The principles of ICH GCP those involved with the conduct of clinical research, and the frameworks and guidelines which govern the set up and conduct of clinical research
Demonstrate and understanding of the roles and responsibilities of different individuals and organisations in clinical research
The role of the Institutional Review Board/Independent Ethics (IRB/IEC)
The role and responsibility of the sponsor
Identify a range of essential documents and the purpose of maintaining a trial master file
Understand the process of receiving informed consent and the roles and responsibilities of those involved in this process
Demonstrate the ability to correctly and accurately complete case report forms and other relevant documentation and understand the process for data query resolution
Demonstrate an awareness of the correct safety reporting requirements that ensure patient safety
Who Should Enroll :
All Personnel involved in Clinical Research
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