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GCP Training

GCP Training

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SMO-Pharmina offers GCP Training Program, that is recognized by the Professional Development Council of the Ministry of Labor, Health and Social Affairs of Georgia. Also our ICH E6 GCP Investigator Site Training is recognized to meet 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 listeneres, who successfully complete the training are  granted with international Certificate.

GCP Training - includes an overview of 13 principles of Good Clinical Practice according to E6 (R2) 2016 guideline and covers following topics:

  1. Introduction to GCP and Clinical Trials
  2. Roles and Responsibilities of Clinical Trial Parties
  3. Independent Ethics Committee 
  4. Roles and Responsibilities of Investigator
  5. Informed Consent
  6. Management of Investigational Product
  7. Patient Safety and Adverse Events
  8. Randomization/Unblinding, CRF completion, etc. 
  9. Handling and archiving of medical records  and essential documents
  10. Importance of Protocol and Investigator Brochure
  11.  Audit and Monitoring

Along with theoretical material, the program includes practical tasks and group activities that are prepared taking into consideration 11 years of experience and responds to the needs of the local Investigators.

The training course is prepared in Georgian and is conducted by highly qualified and certified trainers, who hold several international GCP certificates, and continue practice in clinical studies.

GCP Principles