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Dinner Short Course: How to Implement RBM on a Budget
Organized by Cambridge Healthtech Institute (CHI), to be held at the 6th Annual Clinical Trial Innovation Summit.
WHERE: The Westin Copley Place, Boston, MA
With the FDA and EMA Risk-Based Monitoring (RBM) guidance's as well as the upcoming ICH E6 (R2) changes, the clinical research industry is looking for ways to ensure they meet the regulatory and GCP requirements for the adequate monitoring of clinical trials. There are many technology companies that provide RBM-type of services, but it can get costly and it can be challenging to assess what is most critical to have in order to meet the minimum requirements for RBM. Many organizations do not have large budgets and endless resources to implement such a program. This course will provide the participants with a deeper understanding of RBM and be able to implement RBM with a limited budget and resources.
Key Learning Objectives/Why You Should Attend:
-- Understand the minimum requirements for RBM to meet ICH E6 (R2) changes
-- How to assess your organizations needs and requirements for RBM
-- Identify the impact of RBM to your organizations current workflow
-- How to assess techniques, tools, and technologies for RBM and how to decide what is right for your organization
-- Write an RBM implementation plan
-- Write a risk-based monitoring plan
Course Agenda Overview:
-- Completion of an "Organizational Assessment Tool" for your organization
-- Identify the critical findings of your organization that may impact your implementation of RBM
-- Assess the various techniques, tools, and technologies for RBM and decide on what is right for your organization
-- How to write an RBM implementation plan
-- How to write a risk-based monitoring plan
Brian Nugent, Director, PALM, Clinical Operations, Gilead Sciences
Angie Maurer, RN, BSN, MBA, Clinical Operations Consultant, PALM/Clinical Operations, Gilead Sciences
For more information, visit http://www.clinicaltrialsummit.com.
How to Register:
About Cambridge Healthtech Institute (www.chicorporate.com)
Cambridge Healthtech Institute (CHI), founded in 1992, is the industry leader in providing superior-quality scientific information to eminent researchers and business experts from top pharmaceutical, biotech, and academic organizations. Delivering an assortment of resources such as events, reports, publications and eNewsletters, CHI's portfolio of products include Cambridge Healthtech Institute Conferences, Barnett Educational Services, Insight Pharma Reports, Cambridge Marketing Consultants, Cambridge Meeting Planners, Knowledge Foundation and Cambridge Healthtech Media Group, which includes Bio-IT World and Clinical Informatics News.
Cambridge Healthtech Institute (CHI)