Trainings and Seminars

        1 GCP trainings

           ESMAR provide workshops and trainings for clinical monitors and investigators in the field of clinical trials.

 

           Our Training programs:

Basic course for organization and conduct of clinical trials:

Good Clinical Practice (ICH GCP)

Courses duration: 2 weeks (49 hours)

-        Organization of the clinical trial conduct

-        Ethics issues of the clinical trial conduct

-        Roles and responsibilities of all parties involved in the clinical trials. Audit. Monitoring

-        Essential documents of the clinical trial

-        Good Clinical Practice (ICH GCP)

-        Pharmacovigilance. Recording of adverse events in the course of the clinical trial

-        Regulatory Requirements for the Conduct of Clinical Trials in Russia /Ukraine

CRA Training Program.

Courses duration: 2.5 months (129 hours).

-        Clinical Monitor as a part of study team

-        Organization and conduct of feasibility and study initiation

-        Regulatory requirements for the clinical trial conduct in Russia and Ukraine and submission of documents (optionally)

-        Logistics of the investigational medical product and clinical study materials

-        Working with files (TMF, ISF)

-        Performance of monitor’s visits (evaluation, initiation, monitoring, close-out)

-        Drug accountability at the site

-        Requirements for the source study documents and data verification procedure

-        Pharmacovigilance. Recording of adverse vents in the clinical trial

-        Audits and inspections

-        Statistical issues and data management processes in clinical trials.

 

 

Site Personnel Program

Courses duration: 2 months (84 hours) 

 

Trainings on equipment in clinical trials.

Courses duration: one-day workshops.

-        Trainings on equipment in clinical trials.

-        Training cycles on basics of ECG, spirometry etc.

-        Training on therapeutic fields regarding to the trend of the study.

 

2. Organization of Investigators’ Meetings, workshops and conferences

ESMAR conducts Investigators’ meetings for new clinical trial project and international conferences in the field of clinical pharmacology of the new medical products and pharmaceutical medicine.

-        The detailed plan of the future event and meeting’s clear budget

-        Search and booking of the place which would be suitable for conduct of the conference (hotel, convention hall etc.)

-        Accommodation services for the participants

-        The required technical equipment

-        Booking and purchase of the tickets (air, railroad), transfer

-        Food for the participants, catering, banquets and coffee breaks.

-        Distribution of invitations (informing of all the event participants about place and time of the event using the previously prepared lists)

-        Visa support

-        On-line registration, Web-translation, webinars, telehealth care conferences

-        Rendering services of translators, interpreters, simultaneous interpreters

-        Assistance in preparation of presentation materials, preparation of all types of standard and exclusive printed production, multimedia presentations, booklets, visit cards, news-bulletins and other types of print media materials

-        Photographing and video shooting, recording on DVD or memory card