June 28-29, 2019
Monitoring with auditor's eye (online)
Register
June 28-29, 2019
Monitoring with auditor's eye (online)
What makes this training special
  • In recent years, new monitoring methods are being introduced actively (for example,
    risk-based monitoring); study protocols are flowing with procedures, and the technical
    part of studies is becoming more complicated
  • The monitors' workload is growing; for the reasons of profitability and cost-
    effectiveness, role of the monitor is being downplayed to easy and quick comparison
    between the source documents and data in the case report forms, as well as to making
    high number of visits and encouraging the investigators to enroll more patients rapidly
  • But the monitors play a key role in the process of a clinical trial conduct. If you look
    closer, not only do they control, but also assure the study quality
  • During this training, we will return the monitors to their important place in the system of clinical trial quality management and give them auditors' instruments (not only eyes, but also real working instruments and methodology) to use during routine visits (site selection, initiation, monitoring and close-out)
  • We will also review a series of practical cases, main system findings, errors, and trends, which are being discovered by auditors and inspectors worldwide. We well learn how to avoid them in real practice
  • We will also review a series of practical cases, main system findings, errors, and trends, which are being discovered by auditors and inspectors worldwide. We well learn how to avoid them in real practice
Who will benefit from this training?
This course is intended for managers and experts in quality management, auditors, pharmaceutical companies and CRO employees, as well as for the investigators
Program
June 28-29, 2019
Day 1
09:00- 10:30
Day 1
09:00- 10:30
International and local trends in legal regulation of clinical trials
Maxim Bunimovich, independent international GCP auditor, QA consultant,
trainer (TMQA)

10:30—10:45
10:30—10:45
Coffee break
10:45—11:45
10:45—11:45
New approaches to monitoring, risk-based monitoring experience
11:45–13:00
11:45–13:00
Clinical trials monitoring according to ICH GCP. Monitor's role
Maria Leer, clinical research quality assurance manager in one the largest global
pharmaceutical companies

13:00—14:00
13:00—14:00
Lunch
14:00—15:30
14:00—15:30
Quality management systems in clinical research. Quality control and quality assurance. Place of monitoring
15:30-16:30
15:30-16:30
Investigational site selection. Workshop
16:30—17:30
16:30—17:30
Investigational site initiation. Workshop
Day 2
09:00- 10:30
Day 2
09:00- 10:30
Investigational site monitoring. Procedures of source data review and CRF review with source data verification (SDR vs. SDV). Investigational product accountability. Workshop
10:30—11:00
10:30—11:00
Coffee break
11:00—12:00
11:00—12:00
Monitoring using electronic source documentation
12:00—13:00
12:00—13:00
How to effectively manage discrepancies and what is the plan of Corrective and Preventive Actions (CAPA)? Workshop
13:00–14:00
13:00–14:00
Lunch
14:00—15:00
14:00—15:00
Effective communication with the investigational site. Monitor as a coach and monitor as a psychologist. Workshop
15:00—16:30
15:00—16:30
Investigational site close-out. Workshop
16:30—17:30
16:30—17:30
Preparation for an audit or an inspection role of the monitor. Workshop
What to expect
New vision
We will revise the monitor's role and lead the trial quality to a new level
Real instruments
We will give real working instruments to the auditor
Real cases
We will teach you to avoid typical errors using real-life examples
Our team
Key experts in clinical trials conduct, quality
assurance, quality control, and auditing,
members of the British Association of
Research Quality Assurance (RQA)
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
companies
Maxim Bunimovich
Independent GCP consultant
QA consultant, trainer (TMQA), with significant experience in audits and inspections of investigational sites in
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
Преподаватели курса
Ключевые эксперты в области проведения клинических исследований, обеспечения и контроля качества и проведения аудитов, члены Британской Ассоциации специалистов в области качества научных и клинических исследований (RQA)
Maria Leer
Manager
Clinical research quality assurance manager in one the largest global pharmaceutical
companies
Maxim Bunimovich
Independent GCP consultant
QA consultant, trainer (TMQA), with significant experience in audits and inspections of investigational sites in
different countries worldwide, as well as practical experience in the construction of quality management systems for CROs and sites
Book a webinar
More questions? Send us a message to
trainingcenter@crptrials.com or call
+79218760091, +79627058240
June 28-29, 2019
Two days of new knowledge, methods and hints for your work
Starting at RUR 9000
The price is RUR 9000 for a physical person and RUR 15000 for legal entities. Group discounts
Online
The training is web-based. Number of places is not limited.
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