Risk Assessment: Laying the Foundation for RBM

Life Sciences, Clinical Trials, Pharmaceutical Regulation, Pharmaceutical,
  • Thursday, November 14, 2013

Global regulatory authorities have opened the door for sponsors of new medications to apply innovative strategies to monitoring clinical trials using a risk-based approach (RBM) that focuses oversight activities on managing the likely risks to patient safety and data quality.

Guidance, recommendations, and positions are available from numerous authoritative sources, but until now, RBM methodologies have not been able to answer the fundamental regulatory question: How can you demonstrate that you have identified and adequately monitored all of the critical processes and data points in the trial of question?

This program will present a systematic approach to the risk assessment of clinical trials, using methodologies that have been accepted by regulatory authorities as the basis for approvals in other healthcare categories and in other industries. The output of the systematic risk assessment drives the development of specific project plans for a new generation of RBM, to ensure successful implementation and execution of clinical trials.


Michael Macri, Director, Strategic Services,inVentiv Health Clinical

Michael Macri has been in the BioPharmaceutical industry for over 25 years working in Clinical Operations. His expertise includes design, implementation and execution of clinical trials. He began his career at a large Pharmaceutical company in Data Management and then moved to a Clinical Operations. He spent 14 years at a leading Biotechnology company and held a number of positions, including CRA, Study Manager, Project Manager, Regional Manager, and Director of Clinical Field Operation. Michael Joined the CRO industry in 2008 where he was an Area Director responsible for leading site management activities across the Western United States for a large Pharmaceutical company, including oversight of site management activities for oncology studies. Michael has significant experience in strategic planning, problem solving, communication, teamwork, and line management. In addition, he has experience with all phases of Clinical trials, CRO selection and oversight, and organizational change management. Michael has a BS in Medical Technology from Quinnipiac College, an MBA from Sacred Heart University, and he is a certified Project Management Professional. In his current role as Director, Strategic Services, Michael is responsible for leading a global initiative in Risk-Based Monitoring at inVentiv Health clinical.

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Jeffrey Fetterman President, ParagonRx International, an inVentiv Health Business

Jeffrey Fetterman is President of ParagonRx International, a company that develops and operates programs to guide appropriate use of medicines and devices.

He is co-author and co-editor of two books: A Framework for Pharmaceutical Risk Management, that documents a process for the design and implementation of risk management programs for drugs with safety concerns, and Pharmaceutical Risk Management: Practical Applications, that offers pragmatic approaches to fulfill evolving regulatory requirements on the topic.

In previous work, he co-founded Empower Health, a business that integrated care management tools and services to improve clinical health outcomes of people with chronic illness. Fetterman has extensive Pharmaceutical industry experience, having led marketing, medical education, strategic planning, and business development organizations at DuPont Pharmaceuticals and DuPont Consumer Health.

His original work was in the field of nuclear engineering, in which he led the startup safety assessment of a nuclear reactor operated for the Department of Energy. He is an Adjunct Professor in the Lehigh University Healthcare Systems Engineering program that applies industrial systems improvement methods to the complex healthcare system. He is also a board member for First State Innovation which fosters entrepreneurial businesses in the Mid-Atlantic region. He holds a B.S. in Chemical Engineering from Lehigh University and an M.B.A. from Katz School of Business at University of Pittsburgh.

Message Presenter

Who Should Attend?

  • Clinical monitoring professionals
  • Clinical trial quality professionals
  • Clinical Research Associates
  • Project Managers
  • Study Managers in Clinical Operations
  • Clinical Data Managers
  • Biostatisticians

Xtalks Partner

inVentiv Health

inVentiv Health Clinical, formerly PharmaNet/i3, is a leading provider of global drug development services to Pharmaceutical, biotechnology, generic drug, and medical device companies. With 7,000 employees in more than 70 countries, inVentiv Health Clinical offers therapeutically specialized capabilities for all phases of clinical development, bioanalytical services, and strategic resourcing.

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