Test clinici: io, norme GCP, normativo (EMEA, FDA) ispezioni GCP. documenti chiave.

formazione GCP on-line (certificazione GCP)

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1) GCP course for Investigators and CRAs

2) GCP course for Auditors

(see below or for detailed information click Qui)

 

GCP training curriculum

(1)GCP training for Beginners

1: Introduction to GCP
1.1 sfondo
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 Quality Assurance

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 Considerazioni per l'utilizzo di sistemi elettronici in gestione degli studi clinici
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 Le organizzazioni di ricerca a contratto
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 Produzione, Confezione, 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 introduzione
5.3 Monitoring I

6: Sicurezza & 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 statistica
7.8 Direct Access to Source Data/Documents
7.9 Etica
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 (e poveri!) pratica in relazione alla conduzione di studi clinici

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(2) Advanced GCP training

1: Introduction to GCP
1.1 sfondo
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 Quality Assurance

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 Le organizzazioni di ricerca a contratto
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 Produzione, Confezione, 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 introduzione

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: Sicurezza & 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 statistica

7.8 Direct Access to Source Data/Documents

7.9 Etica

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), sponsor, 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 (e poveri!) pratica in relazione alla conduzione di studi clinici

 

12. Farmacovigilanza per Clinical Trials

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A training package has been developed on the basis of the documents developed by ICH membri del comitato direttivo. We wish to thank to:

 

Dr. Peter Arlett
Head of Sector for Pharmacovigilance and Risk Management
European Medicines Agency London UK

 

Dr. Tomas Salmonson
Medical Products Agency
Preclinical and Clinical Investigation Unit Uppsala, Svezia

 

Dr. Christine-Lise Julou
European Federation of Pharmaceutical
Industries AssociationsEFPIA Brussels, Belgio

Dr. AndrР№ W. Broekmans
Schering Plough Research Institute The Netherlands

 

Sig. Shinobu Uzu
ministero della Salute, Labour & Welfare Tokyo, Giappone

 

Dr. Satoshi Toyoshima
Pharmaceuticals and Medical
Devices Agency (PMDA) Tokyo, Giappone

 

Sig. Kazutaka Ichikawa
Japan Pharmaceutical Manufacturers
AssociationJPMA Tokyo, Japan Mr. Kohei Wada
Asia Clinical Development Department
Daiichi Sankyo Co., Ltd. Tokyo, Giappone

 

Dr. Justina A. Molzon
Center for Drug Evaluation and Research (CDER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

 

Dr. Robert A. Yetter
Center for Biologics Evaluation and Research (CBER)
Food and Drug Administration Rockville, MD, Stati Uniti d'America

 

Dr. Alice Till
Science Policy and Technical Affairs
Pharmaceutical Research and Manufacturers of AmericaPhRMA
Washington DC, Stati Uniti d'America

 

Dr. Peter K. Honig
Worldwide Regulatory Affairs and Product Safety
Merck Research Laboratories North Wales, PA, Stati Uniti d'America

 

Mme Alicia D. Greenidge
International Federation of Pharmaceutical
Manufacturers AssociationsIFPMA Geneva, Svizzera

 

Dr. Odette Morin
Director of Regulatory and Scientific Affairs
International Federation of Pharmaceutical
Manufacturers AssociationsIFPMA Geneva, Svizzera

 

Sig. Mike Ward
International Policy Division
Bureau of Policy and Coordination
Therapeutic Products Directorate
Health Products and Food Branch Health Canada

Dr. Lembit Rago
Quality Assurance and Safety : medicinali
HTP/EDM/QSM
World Health Organization Geneva, Svizzera

Dr. Petra Doerr
Swissmedic, Swiss Agency for Therapeutic Products
Berne, Svizzera

1) GCP course for Investigators and CRAs

 

I formatori per i paesi dell'Europa orientale:

 

Dr. Werner Gielsdorf, HSC- Germania

Direttore Generale di progetto TACIS della Commissione europea in CSI, Responsabile di UNCTAD, WTO, ITC ,

Stati Uniti, Banca Mondiale, UNCTAD / OMC,

allenatore della GCP, GLP, PIL,GMP

 

Dr.Zadorin Eugene, dottorato di Ricerca, MBA
Biofarmaceutica Associazione Internazionale,
, GersonВ Lehrman healthcare Council, I primi Clinical Research LLC Altoparlanti
ufficio,head of the Department of Clinical Research of NBScience, Zintro Inc. (Stati Uniti d'America )

 

accreditamento

accreditamento internazionale è stato richiesto da:
HSC-Germania ,NBScience

 

certificazione GCP

GCP certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated job-related knowledge and skills. certificazione del NBScience è concessa in riconoscimento della documentato e verificato esperienza di lavoro e performance di successo su un esame a scelta multipla.

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Programma:

 

Main principles of Good Clinical Practice (GCP).

Regulatory acts of the European Union and International Conference of Harmonization (io).

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.

Consenso informato .

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. certificazione GCP.

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2) On-line corso di formazione in materia di revisione ed ispezione GCP

 

(for detailed information click Qui)

Panoramica :

This GCP auditing course is designed to provide practical training resulting in a harmonised, metodologia di audit comune in Europa. Il ICH GCP guideline implemented in the EU, Giappone e Stati Uniti è ampiamente incorporati in linee guida di tutto il mondo. audit dei sistemi, previously seen as advanced auditing, sono diventati un compito fondamentale di molti gruppi di audit e sono un elemento essenziale delle ispezioni in Europa.

The course material is regularly updated with the objective of experience sharing and a common professional approach in order to pave the way for mutual recognition and acceptance, reducing costs and stimulating efficiency, allowing faster medicinal product development to the benefit of the patients and health care.

 

On-line corso di formazione in materia di revisione ed ispezione GCP

 

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