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Pharma: Clinical Research; Good Clinical Practice

by Eugene Zadorin

Languages: English

Price (from): €1 / day

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About the trainer:

Dr.Zadorin Eugene, Ph.D., MBA
International BioPharmaceutical Association,
GersonВ Lehrman healthcare Council, First Clinical Research LLC Speakers
Bureau, head of the Department of Clinical Research of NBScience, Zintro Inc. (USA)


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Pharma: Clinical Research; Good Clinical Practice by Eugene Zadorin

About the training

#GCP and CRA certification   #GCP knowkedge

In this course you will learn:

What is GCP?

1.3 New GCP Guide 2024

1.4 The Principles of ICH GCP – 2024

1.5 Some General Points

1.6 Documentation and Version Control

1.7 Quality Assurance

Responsibilities of the CA

2.2 Responsibility of the IEC

2.3 Subject Informed Consent Forms (ICF)

Composition, Functions, Operations, Procedures, and Records

Investigator Responsibilities

Investigator Qualifications and Agreements

Adequate Resources

Medical Care of Trial Subjects

Communication with IRB/IEC

Compliance with the Protocol

Investigational Medicinal Product

Randomization Procedures and Un-blinding

Informed Consent of Trial Subjects

Records and Reports I

Premature Termination or Suspension of a Trial

Progress Reports and Final Report(s) by Investigator


Considerations for the use of electronic systems in clinical trial management

Updated information on electronic records and the use of EMRs in clinical research.





  • ICH-GCP (E6-R2) international guidelines

  • Competent Authorities (CA) and Independent Ethics Committee (IEC)

  • Investigator

  • Sponsor’s Responsibilities

  • Monitor’s Responsibilities

  • Safety & Adverse Event Reporting

  • Adverse Drug Reaction Reporting

  • Clinical Trial Protocol and Amendments

  • Investigator Brochure

  • Essential Documents

  • Archiving

  • Examples

Main benefits

  • #Wide collection of the biggest experts
  • #Filters for all kinds of needs
  • #User friendly platform
  • #Fast and cheap
  • #Highest level of proficiency

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