Ensayos clínicos: yo, normas GCP, regulador (EMEA, FDA) inspecciones de BPC. documentos clave.
GCP formación on line (certificación GCP)
1) GCP course for Investigators and CRAs
2) GCP course for Auditors
(see below or for detailed information click here)
GCP training curriculum
(1) GCP training for Beginners
ICH-GCP (E6-R2) international guidelines
1: Introduction to GCP
1.1 Antecedentes
1.2 What is GCP?
1.3 New GCP Guide 2019
1.4 The Principles of ICH GCP – 2019
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Seguro de calidad
2: Competent Authorities (CA) and Independent Ethics Committee (IEC)
2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records
3: Investigator
3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 Records and Reports I
3.11 Premature Termination or Suspension of a Trial
3.12 Progress Reports and Final Report(s) by Investigator
3.13 Archiving
3.14 Considerations for the use of electronic systems in clinical trial management
3.15 Updated information on electronic records and use of EMRs in clinical research.В
4: Sponsor’s Responsibilities
4.1 Quality Assurance and Quality Control
4.2 Contract Research Organizations
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 Manufacturing, Packaging, Labelling and Coding Investigational Products
4.12 Supplying and Handling Investigational Products
4.13 Record Access
4.14 Audit and Inspection
4.15 Noncompliance
4.16 Premature Termination or Suspension of a Trial
4.17 Clinical Trial/Study Reports
4.18 Multicentre Trials
5: Monitor’s Responsibilities
5.1 About this Chapter
5.2 Introducción
5.3 Monitoring I
6: Safety & Adverse Event Reporting
6.1 Adverse Drug Reaction Reporting
7: Clinical Trial Protocol and Amendments
7.1 Trial Objectives and Purpose
7.2 Trial Design
7.3 Selection and Withdrawal of Subjects
7.4 Treatment of Subjects
7.5 Assessment of Efficacy
7.6 Assessment of Safety
7.7 Statistics
7.8 Direct Access to Source Data/Documents
7.9 Ethics
7.10 Financing and Insurance
7.11 Publication Policy
8: Investigator Brochure
9: Essential Documents
9.1 Archiving
9.2 Documents to be Present Pre-Study
9.3 Documents to be Added During the Study
9.4 Documents to be Added Post-Study
10 Examples
10.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials
ICH-GCP (E6-R2) international guidelines
(2) Advanced GCP training
1: Introduction to GCP
1.1 Antecedentes
1.2 What is GCP?
1.3 New GCP Guide
1.4 The Principles of ICH GCP
1.5 Some General Points
1.6 Documentation and Version Control
1.7 Seguro de calidad
2: Competent Authorities (CA) and Independent Ethics Committee (IEC)
2.1 Responsibilities of the CA
2.2 Responsibility of the IEC
2.3 Subject Informed Consent Forms (ICF)
2.4 Composition, Functions, Operations, Procedures and Records
2.5 How to avoid Ethics Committee issues;
2.6. How to minimize safety issues;
2.7. Measures to protect confidentiality of clinical trial subjects;
2.8 Revisions and updates to the section on HIPAA and privacy.В В
3: Investigator
3.1 Investigator Responsibilities
3.2 Investigator Qualifications and Agreements
3.3 Adequate Resources
3.4 Medical Care of Trial Subjects
3.5 Communication with IRB/IEC
3.6 Compliance with the Protocol
3.7 Investigational Medicinal Product
3.8 Randomization Procedures and Un-blinding
3.9 Informed Consent of Trial Subjects
3.10 The best practices in obtaining informed consent;
3.11 How to assess good oversight by a Principal Investigator;
3.12 Records and Reports I
3.13 Premature Termination or Suspension of a Trial
3.14 Progress Reports and Final Report(s) by Investigator
3.15 Archiving
3.16 В Considerations for the use of electronic systems in clinical trial management
3.17 Updated information on electronic records and use of EMRs in clinical research.В
4: Sponsor’s Responsibilities
4.1 Quality Assurance and Quality Control
4.2 Contract Research Organizations
4.3 Trial Design
4.4 Trial Management, Data Handling and Record Keeping
4.5 Investigator Selection
4.6 Financing
4.7 Notification/ Submission to Regulatory Authorities
4.8 Gaining CA approval in the EU
4.9 Confirmation of Review by IRB/IEC
4.10 Information on IMP
4.11 What clinical trial processes should be covered by SOPs;
4.12 The impact and principles of good vendor oversight;
4.13 Optimal management of IMP;
4.14 How to avoid Ethics Committee issues;
4.15 Ensuring data quality by enhancing data management systems.
4.16 Manufacturing, Packaging, Labelling and Coding Investigational Products
4.17 Supplying and Handling Investigational Products
4.18 Record Access
4.19 Audit and Inspection
4.20 Noncompliance
4.21 Premature Termination or Suspension of a Trial
4.22 Clinical Trial/Study Reports
4.23 Multicentre Trials
5: Monitor’s Responsibilities
5.1 About this Chapter
5.2 Introducción
5.3 Monitoring I
5.4 Understand current thinking on risk based monitoring approaches and develop appropriate monitoring strategies for your study
5.5. Develop superior strategies for selecting sites, recruiting patients and motivating investigational sites
5.6. Significantly improve your performance as a monitor to an advanced level
5.7. Use effective planning and tracking tools to maximize efficiency as a monitor
5.8. Develop strategies for dealing with complex monitoring issues
5.9.Gain expertise in monitoring oversight activities
6: Safety & Adverse Event Reporting
6.1 Adverse Drug Reaction Reporting
7: Clinical Trial Protocol and Amendments
7.1 Trial Objectives and Purpose
7.2 Trial Design
7.3 Selection and Withdrawal of Subjects
7.4 Treatment of Subjects
7.5 Assessment of Efficacy
7.6 Assessment of Safety
7.7 Statistics
7.8 Direct Access to Source Data/Documents
7.9 Ethics
7.10 Financing and Insurance
7.11 Publication Policy
8: Investigator Brochure
9: Essential Documents
9.1 Archiving
9.2В В Documents to be Present Pre-Study
9.3 Documents to be Added During the Study
9.4 Documents to be Added Post-Study
10. GCP audits and inspections;
10.1The difference between audits and inspections;
10.2 The types of inspections at a sponsor or CRO or investigational site;
10.3 How best to prepare for an inspection;
10.4 Best practice for conduct during an inspection;
10.5 Common inspection findings and how to prevent their occurrence;
10.6 How to respond to inspection findings;
10.7 Construction of a plan for corrective and preventative actions.
10.8 The most common findings in Health Authority GCP inspections;
10.9 Review the regulations and guidance that governs clinical research compliance
10.10 Discuss GCP Auditing as a profession and how it differs from monitoring
10.11 Determine who gets audited and key factors and metrics for assessing when or why to audit
10.12 Explore how the FDA,EMEA,MHRA and local RB trains its inspectors to audit Clinical Investigators (Sites), Sponsors, and В Institutional Review Boards (IRBs)
10.13 Apply a quality-systems framework for assessing data and systems
10.14 Implement data trend analysis to identify regulatory risks
10.15 Develop practical auditing skills using real-life audit examples
10.16 Participate in role-play to enhance communication proficiency (Intake and Output)
10.17 Communicate comprehensive findings with writing exercises and group discussions
11 Examples
11.1 Practical examples of good (and poor!) practice in relation to conducting clinical trials
12. Pharmacovigilance for Clinical Trials
A training package has been developed on the basis of the documents developed by Miembros del Comité Directivo de ICH. Queremos agradecer a:
Dr. Peter Arlett
Jefe de Sector de Farmacovigilancia y Gestión de Riesgos
Agencia Europea de Medicamentos Londres, Reino Unido
Dr. Tomás Salmonson
Agencia de productos médicos
Unidad de Investigación Clínica y Preclínica Uppsala, Suecia
Dr. Christine-Lise Julou
Federación Europea de Farmacia
Asociaciones Industriales – EFPIA Bruselas, Bélgica
Dr. AndrР№ W. Broekmans
Instituto de Investigación Schering Plough Países Bajos
Señor. Shinobu Uzu
Ministerio de Salud, Labor & Bienestar Tokio, Japón
Dr. Satoshi Toyoshima
Farmacia y Medicina
Agencia de dispositivos (POR FAVOR) Tokio, Japón
Señor. Kazutaka Ichikawa
Fabricantes de productos farmacéuticos de Japón
Asociación – JPMA Tokyo, Japón Mr. Kohei Wada
Departamento de desarrollo clínico de Asia
Daiichi Sankyo Co., Limitado. Tokio, Japón
Dr. Justina A. Molzon
Centro de Evaluación e Investigación de Drogas (CDER)
Administración de Alimentos y Medicamentos de Rockville, Maryland, Estados Unidos
Dr. Robert A. Yetter
Centro de Evaluación e Investigación Biológica (CBER)
Administración de Alimentos y Medicamentos de Rockville, Maryland, Estados Unidos
Dr. Alice Till
Política científica y asuntos técnicos
Investigación Farmacéutica y Fabricantes de América – PhRMA
Washington DC, Estados Unidos
Dr. Peter K. miel
Asuntos Regulatorios Mundiales y Seguridad del Producto
Merck Research Laboratories Norte de Gales, Pensilvania, Estados Unidos
Ms. Alicia D. Greenidge
Federación Internacional de Farmacia
Asociaciones de fabricantes – IFPMA Ginebra, Suiza
Dr. Odette Morin
Director de Asuntos Regulatorios y Científicos
Federación Internacional de Farmacia
Asociaciones de fabricantes – IFPMA Ginebra, Suiza
Señor. Mike Ward
División de Política Internacional
Oficina de Políticas y Coordinación
Dirección de Productos Terapéuticos
Productos de salud y rama de alimentos Health Canada
Dr. Lembit Rago
Garantía de calidad y seguridad : Medicamentos
HTP / EDM / QSM
Organización Mundial de la Salud Ginebra, Suiza
Dr. Petra Doerr
Swissmedic, Agencia Suiza para Productos Terapéuticos
Berna, Suiza
1) GCP course for Investigators and CRAs
Entrenadores para países de Europa del Este:
Dr. Werner Gielsdorf, HSC- Alemania
Gerente general del proyecto TACIS de la Comisión Europea en la CEI, Gerente de UNCTAD, EN ESO, ITC ,
YO, Banco Mundial, UNCTAD / OMC,
entrenador de GCP, GLP, PIB,GMP
Dr.Zadorin Eugene, Doctor, MBA
Asociación internacional biofarmacéutica,
, GersonВ Lehrman healthcare Council, First Clinical Research LLC Speakers
Oficina,head of the Department of Clinical Research of NBScience, Zintro Inc. (Estados Unidos )
Acreditación
Se ha solicitado acreditación internacional de:
HSC-Alemania ,NBScience
certificación GCP
GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. La certificación de NBScience se otorga en reconocimiento de la experiencia laboral documentada y verificada y el desempeño exitoso en un examen de opción múltiple.
Programa:
“Main principles of Good Clinical Practice (GCP).
Regulatory acts of the European Union and International Conference of Harmonization (yo).
Responsibilities and the rights of the parties participating in clinical trials.
Interaction of Sponsor and Investigator.
Responsibilities of Investigator, Sponsor according to principles of Good Clinical Practice (GCP)
“Ethical aspects of clinical trials of medical products.
Informed consent .
File of Investigator; keeping of documentation.
Legal and regulatory base of clinical trials of medical products in Europe.
FDA and EMEA.
The basic requests to the documentation for clinical trials of medical products.
Regulatory inspections of FDA and SPhC.
Types of inspections.
Responsibilities of Sponsor, Investigator and Inspector at the time of audits.
“Specific clinical trials and GCP regulations in your country”
Testing. certificación GCP.
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2) On-line curso de formación sobre la auditoría e inspección GCP
(for detailed information click here)
Visión de conjunto :
Esta auditoría GCP curso está diseñado para proporcionar una formación práctica que resulta en una armonizado, metodología de auditoría común en Europa. los I GCP guideline implemented in the EU, Japón y EE. UU. Se están incorporando ampliamente en las directrices de todo el mundo. Auditorias de sistemas, previously seen as advanced auditing, se han convertido en una tarea básica de muchos grupos de auditoría y son un elemento esencial de las inspecciones en Europa.
El material del curso se actualiza regularmente con el objetivo de compartir experiencias y un enfoque profesional común para allanar el camino para el reconocimiento y la aceptación mutuos, reduciendo costos y estimulando la eficiencia, permitiendo un desarrollo más rápido del medicamento en beneficio de los pacientes y la atención médica.
On-line curso de formación sobre la auditoría e inspección GCP
