2014 - Risk Management and Risk-Based Monitoring

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
Clinical Research Associates
Monitors
Data Management Team
Project Management Statisticians
Clinical Research Outsourcing
Drug Suppliers
All clinical research professional embarking on a risk-based approach
Price Tags:
Live
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
Speaker Profile
Jane Tucker :
Over the past 28 years Jane has moved from routine data cleaning activities, via computer system validation onto training and data quality activities, eventually specializing in Quality Risk Management. Jane has worked for a variety of large pharmaceutical companies and CROs before retiring from GlaxoSmithKline. Jane now operates as a Risk Management Trainer and Consultant, specializing in Study Level Risk Management and Risk Based Monitoring as well as facilitation of risk assessment workshops.
Sue Fitzpatrick :
Sue Fitzpatrick joined the Pharmaceutical Industry in 1980. She has been responsible for the management and audit of CRAs and clinical trials in a wide range of therapeutic areas. As former Head of Education and Training at the Institute of Clinical Research she was responsible for the provision of training courses for the industry and postgraduate courses in collaboration with several UK Universities.
Reach Us
Compliance Trainings
5939 Candlebrook Ct,
Mississauga, ON L5V 2V6,
Canada
Customer Support : #416-915-4458
Email : support-AT-compliancetrainings.com.