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Adapting Risk Management Principles to Nontraditional R&D Settings
Session Chair(s)
Michael Hamrell, PhD, RAC
President
MORIAH Consultants, United States
Headline risk is of perpetual concern for companies in the biopharmaceutical and biotechnology markets. As regulatory scrutiny directed toward companies that develop vaccines, immunotherapies, recombinant DNA/gene therapies, and other biologically-derived products increases, so does public awareness of the importance of biosafety and biosecurity. Product integrity is more important than ever, and is a direct function of quality programs. This session will discuss quality assurance/quality control programs that would benefit from a robust and integrated risk management program.
Learning Objective : Identify the major components of a robust risk management program; Assess QA/QC programs that would benefit from an integrated risk management platform; Integrate fundamentals of risk management (biosafety, biosecurity) into existing QA/QC programs.
Speaker(s)
Risk Management Considerations in Clinical Trials for Serious Diseases
Michael Hamrell, PhD, RAC
MORIAH Consultants, United States
President
Site-Specific Risk Management for Human Gene Therapy Trials
Chris Jenkins, PhD, MPH
Clinical Biosafety Services, LLC, United States
Principal Partner and Chief Gene Therapy Biosafety Officer
Considerations on the Design of Phase 2 Efficacy Studies for Ebola Therapeutics: Industry Perspective
Thomas Moensch, MD
Mapp Biopharmaceutical, Inc., United States
Chief Medical Officer
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