Good Clinical Practice- GCP

GCP-001:GCP Training for Clinical Investigation Teams​

Online Training Id: GCP-001

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

Learning Objectives:

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

Author:

Dr. Boris Borissov MD  CLINICAL RESEARCH –PHARMACOVIGILANCE

 

 

 

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.

GCP-002:Complying with GCP – “The 12 rules” and a bit more

Online Training Id: GCP-002

Geographical Region: International

Level: Basic

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/

 

CPD Credit hours: 90 mins

Author:

Dr. Boris Borissov MD  CLINICAL RESEARCH –PHARMACOVIGILANCE

 

 

 

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.

GCP-003:RISK BASED MONITORING and Clinical Data Transparency

Online Training Id: GCP-003

Level: Intermediate

Under the current GCP umbrella, applying a risk-based approach to the monitoring and site management activities should be based on a given project’s risk profile. This course will outline the techniques of RISK BASED MONITORING methodology which describes the steps taken to assess risk, to determine Critical Data and Processes, and to mitigate those risks through the utilization of the Integrated Quality Risk Management Plan (IQRMP). Well-designed protocols and case report forms (CRFs) are considered important foundational influencers with an impact on quality and efficient monitoring.

Learning Objectives:

  • Describe the concepts and activities of a Risk-Based Monitoring approach

  • Investigate the regulatory and industry rationales for Risk-Based Monitoring

  • Recognize where risk-based decision making fits into the clinical quality system

  • Identify risks for a project related to monitoring

  • Identify components to include in building the project profile risk score

  • Apply risk factors to various study decisions, i.e., monitoring plan, site assignments, and frequency

Who Should Enroll:

All those involved in Clinical Research – Sponsors / CROs (e.g. CRAs, PMs, CRA Managers)

Author:

Paula Valeria Casasco  EXECUTIVE DIRECTOR OF PICRIS

 

Prior to founding Pi-CRIS, Ms. Casasco grew from key clinical research positions towards management functions within International Pharmaceutical and CRO companies. She developed functions on a regional basis, throughout Latin-America. Her last position before becoming an independent consultant was Latin-American Quality and Training Manager for a major European Pharmaceutical Company.

With more than 15 years of experience in clinical research, she contributes to education within the clinical research industry coordinating and delivering training programs for foundations and universities. Currently guess editor of Barnett GCP Question and Answers guide 2014 & 2015 Edition (chapter Latin America).

Ms. Casasco has conducted over 25 GCP audits within the last 3 years, as well as designed Quality Systems for Clinical Research Units and prepared sites for inspections.

She has a degree in Molecular Biology and a Master in Business Administration. Prior to enter the clinical research field, Ms. Casasco had a fellowship at the NIDR, National Institutes of Health, Bethesda, Maryland, USA.

GCP-004:What to expect from a GCP audit/inspection?

Online Training Id: GCP-004

Available: From January 2017

A GCP audit is conducted with the aim of determine whether or not the clinical trial is/was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of the main auditing techniques used by an auditor and/or a regulatory authority’s inspector as well as the most frequent findings from Clinical Investigational Sites.

Learning Objectives:

  • Discuss how quality assurance differs from quality control and who should be  responsible for each

  • Describe the typical GCP audit steps and conduction

  • Outline best practices when receiving a GCP audit/inspection

  • Review recent noncompliance trends and regulatory focus for Sites and  Sponsors

Who Should Enroll:

All those involved in Clinical Research, particularly QA auditors, CRAs, PMs, SCs and investigators– Sponsors / CROs (e.g. CRAs, PMs, CRA Managers)

Author:

Dr. Gary Bird  PH.D.

 

 

Thomas G. (Gary) Bird, Ph.D. is co-founder of PharmaConsult Global, Ltd., an international cooperative supplying GXP quality consulting services and  President, PharmaConsult-US, LLC. He served as Director of Corporate Quality for GTx, Inc. (Memphis, TN, USA) from 2003 until 2013 and was responsible for confirming all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) related activities were conducted in compliance with appropriate laws and regulations. 

He developed all Quality Systems to support the growth of the small pharmaceutical company and led an NDA submission team.  Prior to joining GTx, he was with Eli Lilly and Company from 1995 to 2003, serving as Senior Quality Advisor for Biotechnology in Corporate Quality Assurance and Senior Regulatory Consultant, CMC Regulator Affairs. 

He was with the FDA from 1990 to 1995 in both CDER and CBER where he was Assistant to the Deputy Director.  During his time with Lilly and FDA he represented both PhRMA and the FDA in the International Conference on Harmonization negotiations on four (4) different agreed guidances. 

He approved and signed documents on behalf of both organizations.   He was secretary for all ICH Working Committees for documents on which he worked including Biotech Stability (Q5C), Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E); Specifications:  Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Q6B) and  The Common Technical Document for CMC Submissions (M4).   Dr. Bird holds a Ph.D. in Biochemistry/Entomology from Mississippi State University.

This Package Includes:

  1. GCP Training for Clinical Investigation Teams

  2. Complying with GCP – “The 12 rules” and a bit more

  3. Risk Based Monitoring and Clinical Data Transparency 

  4. What to expect from a GCP audit/inspection?

GBP 75.00
GBP 100.00
GBP 150.00
To be advised upon registration

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