Webinar On Risk Management and Risk-Based Monitoring

Event Details

Time: February 2, 2015 from 1pm to 2pm
Location: Online
Street: 5939 Candlebrook Court
City/Town: Mississauga
Website or Map: https://compliancetrainings.c…
Phone: 4169154458
Event Type: webinar
Organized By: Compliance Trainings
Latest Activity: Dec 12, 2014

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Event Description

On Going Christmas Offers: Offer valid till 1 st January 2015

1. Register an attendee for Single Live:

Get 10% of on every Registration

First 10 attendees will receive recording Access to the webinar for No Additional Cost

For Coupon Code call customer support: 416-915-4458

2. Register your Group for Corporate Live:

Get 15% of on every Registration

Every group registrant will receive Recording Access to the webinar for No Additional Cost

For Coupon Code call customer support: 416-915-4458

3. Unlimited viewing for 4 days

4. The discounted amount will appear after entering the Coupon Code in the Secure Check Out Page

Description :

This course provides an understanding of risk management principles and makes the links between study level risk management and the implementation of risk based monitoring.

New regulations with regard to Risk Based Monitoring were released by FDA in August 2013 to build on those for Quality Risk Management (ICH Q9) released in 2005 by ICH and 2006 by FDA. In addition there is permanent pressure on resources for clinical trials and it is vital that those precious resources are utilized there they deliver greatest benefit.

The implementation of risk-based study specific monitoring strategies, plans will be a critical component for every study sponsor to ensure high quality and integrity of data, enhance human subject protection, reduce cost and eliminate inefficiencies across clinical trial process. Thorough identification and evaluation of risks to critical study data, processes and thereby designing appropriate monitoring plan with a balance of centralized & onsite monitoring will maximize the effectiveness of risk based monitoring.

Considering the importance and need of risk-based monitoring currently in clinical trial management, it is recommended to attend this webinar that provides more insight on this new approach.

Areas Covered in the Session :

Regulatory requirement

Broad review of risk based activities

Study level risk management

RBM – adding value to your operations

What may generate risk?

Risk management documentation/risk statement structure

How to get started

Actions and how to manage them

Practical implications

Who Will Benefit:

A must attend webinar for all