GCP training for professionals of pharmaceutical industry (basic course).

8 - 9 June 2012, Moscow.

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Fotos from the training on a facebook page.

Principles of observational studies

Seminar for the specialists in marketing and clinical studies. 9 April 2012, Moscow.

  • Importance of epidemiology for pharmaceutical market.
  • Observational studies in medical science and in pharmaceutical business.
  • Types of observatio    Standard GEP (Good Epidemiological Practice).
  • Observational studies and legal rules.
  • Data management and statistical analyses in observational studies.
  • Ethical aspects of observational studies.
  • Publication of the results. Standard STROBE (STrengthening in the Reporting of OBservational studies in Epidemiology).

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Photos

"GCP for investigators. Introductory level" Haematology Scientific Centre of RAMS 2-3 March 2012.

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Photos on a facebook page

'GCP for investigators. Introductory course'. Federal Centre of Children Haemotology, Oncology and Immunology. Moscow, 24-25 February, 2012.

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Fotos

Seminar 'Studies of Drugs Equivalence'. Moscow, 29 August 2011.

Program

  • New generic drugs: history, conglicts and trends.
  • Principles of drug equivalence assessment.
  • Biosimilars. Features of investigation and registration.
  • GLP (Good Laboratory Practice) in bioanalytics.
  • Bioanalytical laboratory – view from the trench.
  • Legal rules and BABE studies.
  • Clinical part of BABE study.
  • Therapeutical equivalence studies.
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GCP for study nurses. 11-12 August 2011.

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Fotos

GCP training in Vishnevsky's Institute of Surgery.

Moscow, 16-17 August, 2011.

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Fors

  • Data management&Statistics

    Data management

    • Paper and web-based CRF
    • Data base (SQL)
    • Double entry
    • System of QA/QC data entry process
    • Coding
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  • Study concept&protocol

    • Study concept development
    • Collaboration with medical experts
    • Protocol writing
    • Protocol reviewing/adaptation
    • Protocol translation/verification
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  • Monitoring&Audit

    • Monitoring is performed by high qualified and experienced CRAs internal system of CRA training most CRAs have MD qualification
    • Regular internal audit of office,clinical sites and laboratory clinical facilities
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  • Consulting

    • Assistance in the process of registration
    • Document preparation/submission
    • Monitoring of the registration process
    • Drug supply / customs procedures / local partner depoy
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  • Trainings

    • Statistical model development
    • SPSS, SAS
    • Statistical analyses/statistical report
    • Possibility of DSMB organization
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  • Phase I/PK Units

    • I-st phase
      • First-into-Man
      • Microdosing studies
      • Interaction studies
    • Special populations PK studies
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  • IVRS

     
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  • Final Report

    • Statistical report
      • Final study report
      • ICH E3 standard
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  • Phase II-IV

    • Development&Writing
      • protocol
      • case report form (CRF)
      • database
      • investigator's brochure
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  • PK Units

    • 2 Hospital based units for PK-sessions
    • Wards with possibility of simultaneous dosing in 18 patients
    • Trained medical staff
    • Core medical team experience in PK studies since 2008
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  • Study Management

    • Project management
    • Logistic solutions
    • Payment optimisation
    • PK units/PK session organisation
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  • Observational studies

    Seminar for the specialists in marketing and clinical studies. 9 April 2012, Moscow.

    • Importance of epidemiology for pharmaceutical market.
    • Observational studies in medical science and in pharmaceutical business.
    Learn more >>