PharmaSchool Course: Certificate in Risk-Based Monitoring

Description:

Risk-based monitoring is required by latest regulatory changes because it improves patient safety and data integrity. This unique course is specially designed to upgrade your skills to central CRA, or risk manager, by providing easy-to-understand key concepts in combination with a workshop. This is a two day, intensive, practical programme covering the regulatory requirements for Risk-Based Monitoring and incorporating workshops using actual clinical trial data.

Who should come?

This course is aimed at those who will be involved in implementing a risk based approach to monitoring as required by ICH GCP (R2) This could include:

  • Current monitors
  • Individuals training to become central monitors
  • CRA Managers
  • Project Managers
  • Data Managers
  • Medical Monitors

Course Objectives:

By the end of the programme attendees will be able to:

  • Outline the regulatory requirements for Risk Based Monitoring
  • Review a protocol and establish a list of risks with their risk indicators for such a protocol
  • Implement a holistic RBM in a clinical research setting avoiding the most common pitfalls for a clinical trial

Faculty and Course Overview:

Jo Burmester, Director Global Operations, PharmaSchool - RBQM Theory and Regulatory Requirements
Dr. Johann Proeve, Chief Scientific Officer, Cyntegrity - data-driven risk management, KRIs, QTLs, thresholds
Dr. Artem Andrianov, Managing Director, Cyntegrity - practical workshop - risk assessment and risk control with an automatic RBM system

Practicalities:

Date: 30-31 January 2018
Location: London, UK
Cost: Early bird rate (book before 1 December) 1290 / Regular rate 1490
Included: Both days attendance, Tea/coffee/lunch, workbooks and follow up resources
Not Included: Travel, accommodation

Book a place on this Course

Please use the form below to book a place on the Certificate in Risk-Based Monitoring Course. Once you have completed the details you will be able to either pay online, request an invoice to yourself or your company, or you can print the invoice and send to us together with payment.

Your Name:
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Phone:
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Course:
Certificate in Risk-Based Monitoring

Date:
30th and 31st January 2018

No. of places:
 
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