Take the Risk out of Risk Based Monitoring – Learn What Industry Leaders Are Doing to Implement Inspection-Ready Risk Based Monitoring Practices

Overview: 

Industry leaders have embraced Risk Based Monitoring (RBM) as a method for:

• Improving clinical trial efficiency
• Streamlining resource utilization, and
• Delivering clinical trial cost savings.

However, implementing RBM is not without risk, including regulatory inspection risk.  With the release of the EMA Reflection Paper in 2011 and the FDA Guidance in 2013 the use of RBM is increasing globally and regulatory agencies are now assessing the RBM practices implemented by sponsors. Are you ready?

This webinar will use the lessons learned from the early adopters of RBM, as well as, current industry best practices to inform those currently using RBM or those considering implementing RBM. Practical tools and actionable steps will help guide the implementation of a successful and inspection ready RBM program.

Learning Objectives – Attendees will be able to:

• Understand RBM in the wider Clinical Quality context
• Understand the key concepts and tools used for RBM
• Identify common RBM failures and how to avoid them
• Identify success factors and best practices used by industry leaders
• List 5 steps to ensure RBM practices are inspection ready

Who should attend:

Clinical research professionals with a basic knowledge of ICH-GCP principles. Some knowledge of RBM is preferred but not required.

Participation Benefits:

Practical tools and industry best practices for implementing an inspection-ready RBM program.

Speaker:

Susan Gould, MBA, MS

Principal Consultant

Halloran Consulting Group

Bio: Sue is a Principal Consultant at Halloran Consulting Group. She is an expert on clinical quality, compliance, and technical execution, with over 20 years of experience in the Medical Device and Pharmaceutical industries. She focuses on Quality Systems Regulation (QSR), Phase I-IV Clinical Trials, and Human Factors Evaluations.

Date & Time: March 30th, 2016 at 8:00 AM & 11:00 AM EST

Webinar tuition:

Individual: $360 members/$420 non-members

Group: $960 members/$1140 non-member

Earn CEUs:

Participants are eligible to receive CEUs upon attendance and successful completion of a web-based assessment within 30 days after the webinar. CEUs are not granted after the 30-day assessment deadline. SCDM is authorized by IACET to offer 0.2 CEUs for this program.

Registration link: https://www.mci-registrations.com/scdm/courses.aspx?course=WEBMAR16&grp=true

For more information, please contact info@scdm.org