Pharma: Clinical Research; Good Clinical Practice
by Eugene ZadorinLanguages: English
Price (from): €285 / day
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 2019
1.4 The Principles of ICH GCP – 2019
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
Archiving
Considerations for the use of electronic systems in clinical trial management
Updated information on electronic records and the use of EMRs in clinical research.
...
AND MANY MORE TOPICS WILL BE COVERED
285 Euro/ participant
Program
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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