In August of 2011, the FDA released a draft document “Guidance for Industry, Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring”. This document answered a number of key questions on the development of risk-based monitoring strategies and plans for investigational studies. The document filled in some of the gaps in the industry’s thinking on what a compliant risk based monitoring program should look like, and companies are in different stages of implementing RBM, however many companies are still wrestling with issues related to setting up such a program.
To help the industry better understand the implications, challenges, best practices and lessons learned on how to effectively implement the FDA guidelines, PHARMICA Consulting is proud to host a Risk Based Monitoring conference for the Life Science Industry.
March 19th, 2013 | Boston, MA
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Conference Director's Opening Remarks
Eric Lake - Partner
Analytical Based Monitoring from Concept to Implementation
Paul Burton, M.D., Ph.D.
Clinical Transformation Leader & Head
Trials Coordination and Site Management: Americas
Risk Based Monitoring and Quality Risk Management
David Knepper - Head of Continuous Improvement
The Risk/Knowledge Based Monitoring Partnership – Clinical Operations and Data Management
Deb Manzo, Sr Director, Clinical Business Operations and Transformation AbbVie Inc
Risk Based Monitoring in Early Stage Development – A Predetermined Risk Assessment Approach to Monitoring Targeted Early Studies
Laura Vessey - Director, Clinical Research – Early Stage Operations
Candance Shelton, Director Clinical Monitoring Services
Merck & Co.
Classifying Significant Postmarketing Drug Safety Issues and FDA's Communication to the Public
Najeem Saleem, Pharm.D. - Post Doctoral Fellow - Safety & Benefit Risk Management
Biogen Idec Inc.