Webinar Topic
Risk-based and Remote Monitoring
Webinar Date & Time
23 July 2019 from 10:00 AM to 11:30 AM (CEST)
Webinar Overview
With the increasing complexity of the clinical trials, a need has surfaced for emphasising critical vs less important aspects of clinical trial management. Analysis for the efficacy of the traditional approach to monitoring of clinical trials demonstrated an unfavourable ratio between efforts and effect. ICH GCP E6 R2 defines innovative approaches, which include Quality Risk Management, Quality-By-Design, prioritised resourcing and risk-based monitoring. This webinar will focus on risk-based monitoring as a principal measure for improving the quality and effect of the outcome of the clinical trials monitoring, whilst respecting resourcing needs. Other main topics will include remote and centralized monitoring and their role in the risk-based approach.
Presenters
Goran Vesov
Quality Assurance and Training Director
OPTIMAPHARM
- Assurance and Training Director
- Almost 20 years’ career in Clinical Trials (18 in Quality and Training)
- Background: MD, Specialist in Paediatrics, MSc in Paediatric Endocrinology/Genetics
Ana Stojkovic
Country Manager
OPTIMAPHARM
- Country manager, leading Clinical Operations team in Croatia and Slovenia
- Almost 17 years in field of Clinical Trials (GSK, OPTIMAPHARM), Clinical Operations, Quality/ Trainings
- Background: Doctor of Dental Medicine, Master degree in Periodontology/Infectiology, Integrative psychotherapist
- Both pharma and CRO expertise, experience with FDA inspections, CRA/GCP Training creation and conduct
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
22 July 2019
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Confirmation
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